30 jobs found in bothell

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: We are seeking a highly motivated individual to join our Potency Assay development team in a full-time position. The Potency Assay development team is responsible for the development, qualification and implementation of cell-based assays, binding assays as well as other methods to support the characterization and advancement of therapeutics in the Seattle Genetics pipeline. The candidate will work with the manager to develop assays and generate data to support several on-going stability and development studies. The successful candidate will have strong data analysis and time organization/management skills with attention to detail with desire to achieve team and individual goals. Responsibilities: Perform various assays, including ELISA or cell-based assay Participate in general lab maintenance such as stocking, maintaining equipment and buffer preparation Present data at group meetings May be involved in the development of cell-based potency bioassays or binding assays Requirements: Good communication and interpersonal skills are required Function independently as well as actively participate in team responsibilities Meticulous attention to detail, quality and compliance following assay procedures, data reporting and execution of experiments Must be comfortable working in a fast-paced environment and capable of multitasking ELISA experience and/or knowledge of theory desirable Previous laboratory experience in a development setting is desirable Mammalian cell culture or sterile culture technique experience is desirable Education: A bachelor's degree in Biology (or related field) and 2+ years of laboratory experience would be an asset As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113807499

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Quality . Bothell, Washington Description Summary: Seattle Genetics is seeking an energetic, passionate, and experienced quality professional who will join the Global Quality team in the Quality Systems group. As a QA Sr Associate, this position will be responsible for implementing and overseeing the Digital Archivist activities related to the development of archival policies and procedures for legacy and new records within the GMP Quality file area. This position will work to establish and maintain a scalable and efficient system for storing and accessing data and will report to a Senior Manager of Quality Systems. Responsibilities: Overall responsibility for the management of the physical file rooms and digital record archives including; management of the physical file room, receipt and cataloging of received files, retrieval and logging of requested files, general owner oversight of the electronic archival system As part of team involving Quality Systems Validation and IT, identify, decide on, implement, and maintain a comprehensive electronic archival solution Subject matter expert for the electronic archive solution to be called on during audits and inspections Oversee personnel performing the day to day archival functions Understands and applies the regulations governing the Archive function according to cGxP regulatory requirements Stays abreast of emerging technologies and makes recommendations especially as it relates to file formats, asset migration, and new technologies Conduct archive room verification Engage with off-site digital and physical storage facilities, ordering items as necessary and integrating those assets into archive system Participate in cross-functional team responsible for operational programs and continuous improvement activities, particularly within the areas of responsibility Write/revise quality procedures or other department operating procedures Requirements: Bachelor's degree (Library Science preferred) and 8+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry Basic knowledge of cGxP regulations for documentation practices is highly desired The successful candidate will be able to maintain a high degree of confidentiality and professionalism Able to work well with employees at all levels of skill and authority throughout company Superior attention to detail and organizational skills, immediate response action to tasks and personnel requests for assistance Ability to handle changing priorities if needed in a fast-paced environment Strong written and oral communication skills required Strong computer skills and working knowledge of general MS Office applications Additional Skills Desired: Able to organize information in a consistent and readily retrievable manner Enthusiasm for the work and ability to proactively implement continual improvements desired Strong team player that can also work independently to achieve objective Instills Trust, Directs Work, Drives Engagement, Plans and Aligns As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113775346

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Executive . Bothell, Washington Description Summary: As an Administrative team, we are a group of individuals that love what we do and enjoy the people we work with. We know that the relationships we build are genuine and positively contributes to our work environment. We are intentional in cultivating a culture that is inclusive, collaborative, and celebrates our individual initiatives. To be successful in this role you'll need to be flexible, self-motivated, detail-oriented, and provide exceptional support to the Vice President and their division. You'll be a positive and professional role model in the organization and possess strong decision-making skills, be forward-thinking, collaborative, and have a reputation for problem-solving and troubleshooting in an evolving business environment. Responsibilities: Primary support to the Vice President of Corporate Communications. You will be responsible for creating and maintaining the rhythm of the business through proactive planning and execution of administrative support to ensure a seamless experience for leadership and all employees within the division Proactively manage and maintain VP's complex calendar on a daily, monthly, quarterly, and annual basis to ensure accurate scheduling and prioritization Organize complex and extensive domestic and international travel, which requires assembling travel packets and arranging all travel logistics Manage multiple department budgets and expenses in compliance with company policy; review and approve invoices and account reconciliation. Also includes timely preparation of expense reports Adhere to and execute administrative procedures for the team staying within corporate policy Responsible for flawless planning and execution of onsite and offsite meetings, events, and conferences Assist employees with conference registration and help maintain professional memberships and group rosters for subscriptions Manage sponsorship requests and contracts in the appropriate internal systems Ensure a positive employee experience through the successful onboarding of new hires by making sure all necessary documents and office equipment are in place Backup support for CFO's office and CFO's Executive Assistant Assist with other projects and work as needed and assigned Collaborate with other administrative staff to support department and/or company-wide events and various other initiatives as needed Requirements: 5 - 7 years in an administrative role supporting senior management in a fast-paced, technology-driven environment Ability to apply knowledge of the business and integrate into daily tasks to achieve successful outcomes in cross-functional projects and activities Excellent organizational and interpersonal skills are required Ability to prioritize work and deliver projects completed and on time while facing multiple distractions and interruptions Demonstrates and role models confidence, emotional intelligence, and professionalism Ability to pay close attention to detail when working with complex schedules or projects and react with an appropriate sense of urgency to situations or events that require a quick response or turnaround Ability to independently problem-solve to quickly resolve issues to maintain business continuity The ability to maintain a positive attitude with the ability to adapt quickly to changing priorities; must work well under pressure The desire to learn and grow with the business Able to work successfully in a team environment by building effective working relationships internally and externally with all levels of employees with different working styles and perspectives Promote the Mission, Vision and Values of Seattle Genetics in all areas of responsibility May require travel up to 2-4 times per year for company events and various projects Highly proficient in MS Office products (Outlook, Word, Excel, and PowerPoint); SharePoint a plus Ability to work overtime as needed Education: Associates degree (or equivalent work experience) with 5+ years of experience required Bachelor's degree preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113775403

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Quality . Bothell, Washington Description Summary: Seattle Genetics is seeking a proven senior leader to head the company's Quality organization for Antibody Drug Conjugates, Antibodies, small molecules and other biologics. The role is a member of the executive leadership within Seattle Genetics and a core member of the Tech Ops leadership team. This role will lead the Quality Unit, in order to oversee and manage all aspects of Quality, both internally and externally, for established commercial products, a robust and expanding clinical stage portfolio, and associated with global product launches of the portfolio of products. The role is responsible for establishing and ensuring the operations of Seattle Genetics across the product portfolio and throughout the product lifecycle are commensurate with prevailing and emerging regulatory expectations and industry standards and are founded in strong science. This individual leads a growing team of 110 professionals in the US and Europe, across the functions of Quality Control, Quality Compliance, Quality Systems, Quality Operations and Product Quality. The leader, in collaboration with key peers and stakeholders, create an environment that supports the values of the wider organization including; Learning culture, Speak up mentality, Risk-based thinking, Data-driven decisions and Continuous Improvement. Responsibilities: Active member of the Seattle Genetics Tech Ops Leadership Team engaging with the other members to define the strategy for Tech Ops and ensuring the strategy is supported by Quality through right assignment of resources to provide sufficient quality oversight, timely resolution of issues, and early intervention to assure adequate compliance Direct the Quality Leadership Team and Extended Quality Leadership Team to define the strategy for the Quality Unit and create an agile and flexible global organization, ensure appropriate response to emerging trends and issues, and drive sustainable levels of quality throughout the Seattle Genetics organization Coach, mentor and lead the quality unit, ensuring appropriate organizational structure and levels of accountability to achieve rapid decision-making, streamlined and efficient execution of business strategy and plans, and effective escalation of issues In conjunction with Tech OPs, Research, Development and Commercial functions, provide SME input to and implement robust Quality Oversight systems and technical assessments for Due Diligence, initial qualification, and on-going relationships with Contract Manufacturers and Strategic Partners for clinical and commercial products. Ensure the oversight is in line with emerging regulatory and industry practices and standards Participate at a leadership level to provide strategic CMC guidance for commercial and clinical development teams and allocate resources to support program goals Provide leadership, input, guidance and expertise in establishing Quality Operations in x-US regions to support clinical and commercial efforts and ensuring robust, compliant patient supply Provide leadership and direction for significant events (deviation, adverse events, non-compliance status, other) that could adversely affect product quality, compliance status, or pose significant business risk. Maintain timely and clear cross-functional communication for quality-related topics, including progress on strategic priorities, resolution of issues, emerging trends regarding product performance and compliance. Support/supervise any authority communications and ensure that all BDPRs and other mandated reportings occur on time and with high quality of content Ensure that all CMC functions at all locations are meeting global standards and principles with respect to organization, personnel qualification, training, procedures, processes, performance and productivity Oversee the application and continuous improvement of quality system policies and procedures for assessment and oversight of governed operations, embedded in a culture of risk-based thinking, curiosity, and with an eye towards scalability and flexibility of processes to meet the evolving needs of the business Establish key objectives and metrics for evaluation of the effectiveness of the Quality management Systems and supporting functions and lead Quality Management Reviews including regularly scheduled Executive Committee Quality Reviews Develop and manage strategic plans and budgets for global quality operations Lead and develop a team of senior quality professionals allowing for career progression and succession planning Ensure that Quality programs and units support business objectives Requirements: 20+ years of experience in related commercial and clinical Quality leadership covering GxP quality assurance in both tactical and strategic capacities Extensive background, experience and knowledge of the biologic drug development process. Additional experience in small molecule drug development is a strong plus Established expertise in GxP systems. Extensive knowledge of global regulations and standards Established experience in hosting and managing regulatory inspections from global health authorities including PAIs and periodic quality systems inspections Experience managing quality aspects of global biologics manufacturing network, particularly with managing CMOs Strong people leadership skills including the ability to effectively manage and mentor employees at senior levels (i.e. Director and above). Experience managing and leading an international-based staff, particularly in the EU, is a strong plus. Experience as a change agent is also desirable Proven ability to plan and budget resources effectively across multiple departments with competing priorities Other required leaderships skills are the ability to make tough decisions in a timely manner and the ability to influence executives on critical issues Education: Must possess a degree in related life sciences technical field. An advanced, post-graduate degree is highly desirable As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113775430

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: Seattle Genetics is looking for a motivated Research Associate II to work in Potency and Impurity Assays group. The primary responsibility is to perform routine testing for process-related impurities including HCP, Protein A, glucan and IGF1 LongR3 and deliver quality data. This person will also participate in development and qualification of impurities characterization and quantification method. The desired candidate should have a strong background in protein biochemistry or related discipline and the ability to work both independently and in a collaboration manner. Responsibilities: Perform process-related impurities sample testing, analyze and compile data Assist method development and qualification to meet program needs and timelines Transfer impurity methods and reagents to internal or external manufacturing facilities Summarize and present experimental finding in team meetings, participate in discussions and author tech report Requirements: BS in Biology, Molecular Biology, Cell Biology, Biochemistry, or related field with 2+ years working experience in pharmaceutical or biotechnology industry Proficiency in running ELISAs Practical experience in assay development, method troubleshooting skill and qualification Strong attention to detail Team player, comfortable achieve goals in a team environment and interacting with members within the group and across different departments of the company Excellent organization and time management skills Strong written and verbal communication skills Additional Desired Skills: Experience with JMP or other data analysis or statistical programs (e.g. Excel Macro) Experience with ELISA automation As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113775507

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Translational Sciences . Bothell, Washington Description Summary: We are seeking a highly motivated individual to provide vision, strategy, and leadership in driving the implementation of precision medicine approaches for Seattle Genetics' development programs. This will entail devising and testing patient selection strategies and, when appropriate, the development of companion diagnostics, with the overall goal of identifying the right patients for our promising drug candidates. Collaborating with other groups in Translational Medicine and Clinical Development and with Research, the Diagnostics & Biomarkers group devises and executes strategies to understand mechanisms related to drug response and resistance and to evaluate clinical biomarkers in forming relationships between dose, pharmacodynamic responses, and clinical endpoints. Responsibilities: Develop, articulate, and lead the execution of overarching strategies for elucidating biomarkers of drug response and resistance and the clinical testing of associated hypotheses for patient selection Lead collaborations with senior leaders in Research, Translational Medicine, and Clinical Development to identify potential tumor and immune correlates with response for research-stage programs to inform early development strategies Maintain state-of-the art knowledge in the area by liaising with key opinion leaders on the use of diagnostic approaches and the use of biomarkers, particularly for targeted oncology and immuno-oncology therapies Provide oversight of the development, validation, and execution of clinical biomarker assays, balancing the use of Contract Research Organizations (CROs) with, as appropriate, a strategic build-up and use of internal capabilities In close collaboration with the Clinical Development Operations, Biometrics, and Bioinformatics functions, manage the timely testing of clinical trial samples and the analysis and reporting of the associated data Maintain oversight of companion diagnostic partner evaluation & selection, completion of the associated work at CROs, and related regulatory activities Requirements: PhD, MD, or MD/PhD with 8+ years of experience (or equivalent) in a relevant scientific field (e.g. pathology, immunology, oncology, molecular biology, genetics) Deep understanding of cancer biology, clinical oncology and/or immunology Experience with the research and development of biologic therapeutics or similar academic experience, biomarker assay development, validation & execution in clinical trials Experience and expertise in the development of companion diagnostics with direct involvement in regulatory submissions and interactions with regulatory authorities is preferred; but not absolutely necessary Expertise and extensive experience with the development and validation of protein- and/or nucleic acid-based assays such as Flow Cytometry, IHC, PCR, genomic profiling and gene expression analysis Understanding of clinical operations with the ability to implement well-designed experiments within a clinical trial environment An understanding of translational approaches as applied to clinical trial design and regulatory processes, proof-of-concept studies, and the implementation of biomarkers and diagnostics Excellent communication & organizational skills with a strong business acumen; able to convey complex scientific and business issues to devise, reach agreement on, and implement solutions Ability to collaborate, lead, influence, and motivate others As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113741995

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Drug Safety & Pharmacovigilence . Bothell, Washington | South San Francisco, California Description Summary: The Sr. Safety Scientist will report to the Head of Safety Surveillance and Epidemiology in Drug Safety and Pharmacovigilance and will be primarily responsible for the support of the signal management activities for medical products under development or post marketing. Safety Scientist conducts aggregate analysis for signal detection, signal analysis, signal evaluation and risk management. Responsibilities: Support safety surveillance activities and contribute to safety analysis and risk management planning for designated products Track, detect and evaluate safety signals in consultation with the SERM leads Prepare safety evaluation reports for safety signals or other issues (e.g., product quality) Support the preparation and maintenance of safety sections of Company Core Data Sheet, Investigator's Brochure and ICF for assigned products Prepare and review periodic aggregate safety reports (PADER, PSUR/PBRER, DSUR, IND Annual Report, 6-month line-listings) Support SERM lead in the development and/or execution of RMP, REMS, and Benefit risk analysis Contribute to safety content in the review of clinical protocols and study reports, as needed. Support the SERM Lead in responding to safety requests for assigned product(s) from regulatory authorities, affiliates and other internal functions Represent Drug Safety in cross-functional team meetings for designated product(s) Attend weekly internal safety meetings (Safety Surveillance & Epidemiology and Global Safety Team) and cross-functional meetings to discuss safety concerns and analytic plan Present signal analysis strategy and results to joint safety meetings with co-license partners Requirements: Medical/Clinical degree including MD, PharmD, MPH/PhD, or BS RN degree Minimum of 4-5 years of industry experience or clinical trials research experience in drug safety, epidemiology and/or risk management is desired Oncology safety science experience preferred Experience as a safety epidemiologist or appropriate epidemiology qualification will be desirable Good Knowledge of FDA and EMA drug safety and pharmacovigilance regulatory guidance Good knowledge of drug safety/pharmacovigilance practices and tools (e.g., ARGUS database, TIBCO Spotfire, MedDRA, Medidata) Good medical and scientific judgement, attention to detail and excellent interpersonal skills, including ability to work effectively cross culturally and cross functional Prefer experience in managing direct reports and projects, independently As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113684403

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Drug Safety & Pharmacovigilence . Bothell, Washington Description Summary: The Drug Safety Systems Specialist is a business analysis role in the Drug Safety Systems team that will focus on tasks related to the management and business utilization of the drug safety database, drug safety data and reports. Responsibilities: Business support activities related to the safety database including understanding and documenting business requirements and configuration management Collaborating with IT, internal key stakeholders and external business partners to coordinate the appropriate deliverables for drug safety business requirements and data requests Recommending technical solutions and reports to Drug Safety colleagues by analyzing the needs of the business and aligning with available tools and data Assisting with the implementation and maintenance of tools and systems to support business processes Coordinating Drug Safety Operations report requests and assists with determining needs for aggregate safety data Managing Drug Safety Systems access requests Requirements: Bachelor's degree required Business and data analysis skills in pharmaceutical or related space Business requirements gathering and specification development Creating test scenarios and executing test protocols Strong understanding of Microsoft Office tools including Word, Excel, Power Point and Visio; Excel skills to including pivot tables and functions Time management skills with ability to handle time sensitive deadlines and quickly pivot when unexpected events or changes present themselves Excellent communication (written and oral) and collaboration with technical and non-technical audiences Desired proficiency and experience: 2+ years in in the pharmaceutical industry preferably in one of the following areas: Drug Safety, Clinical Operations, or Regulatory Affairs Direct experience with systems and data that support Drug Safety (e.g., Argus, ARISg) SQL Skills Report development using business intelligence tools with structured data sets As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113684348

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Regulatory Affairs . Bothell, Washington Description Summary: The Regulatory Affairs Specialist supports a senior regulatory professional by executing against the global regulatory plan for one or more products. The successful candidate will develop an understanding of regulatory guidance and precedent in the oncology setting in order to provide effective regulatory and operational support for routine regulatory submissions. Responsibilities: Responsible for preparing and managing routine regulatory submissions for investigational oncology products May serve as Regulatory representative on cross-functional study team meetings May perform regulatory research and assessments to inform global regulatory plans May assist in preparation of responses to health authority requests and preparations for health authority interactions Requirements: Bachelor's degree in a life sciences discipline General knowledge of the US drug development process and regulatory requirements Excellent written and verbal communication skills Strong organizational skills; able to manage conflicting priorities and adhere to tight timelines Proven ability to work with a high level of integrity, accuracy, and attention to detail As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113684553

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Clinical Research . Bothell, Washington Description Summary: This position is for Medical Director/Senior Medical Director within the ENFORTUMAB VEDOTIN Genitourinary program. This position will be responsible for supporting clinical trials and the Genitourinary development strategy for ENFORTUMAB VEDOTIN. The successful candidate will report to the Global Development Lead and should have demonstrated proficiency in leading clinical trials and supporting development programs. The successful candidate should also be adept at managing relationships across collaborations and with the external clinical community. Responsibilities: Establish and drive teams to execute the strategic long-term vision for the program Lead clinical study teams and ensure appropriate medical monitoring for ongoing clinical studies Lead development and maintenance of clinical documents (e.g. protocols and amendments, investigator brochures, clinical study reports) Lead development of clinical study documents to be used in regulatory interactions and filings Develop manuscripts, abstracts and presentations for scientific meetings Advise on current and future clinical development plans within internal and joint development teams Evaluate safety, pharmacology, and efficacy data from ongoing and completed studies to inform clinical strategy Conduct literature reviews and prepare summaries to support clinical development strategies Requirements: MD or MD/PhD 3-5 years industry experience in oncology drug development Has a strong leadership presence and the ability to work effectively with other clinical and scientific leaders Demonstrates a passion for helping patients with cancer and for the science of oncology Has a collaborative style with internal company leadership, external development partners and investigators/medical professionals Is a team player, works well in a team environment, both as a leader and a key contributor Has a global perspective and mindset, with the ability to work effectively with colleagues from myriad cultures, backgrounds and geographies Clinical oncology experience; Board certification in oncology with experience in genitourinary malignancies is preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113684226

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Regulatory Affairs . Bothell, Washington Description Summary: Seattle Genetics is seeking a highly motivated Project Manager who will be responsible for managing and coordinating the late stage research through clinical development Global Regulatory Teams within Regulatory Affairs. This position serves as an essential partner of and support for the Global Regulatory Lead, and as a liaison between the Regulatory Affairs team members and senior management. Responsibilities: Managing and coordinating regulatory team meetings, and preparing agendas, recording meeting minutes and tracking action items Develop, maintain, track, and manage high-quality program timelines, dashboards, team sites and the Regulatory Submission Request information when required, to enable accurate team reporting and decision making Use project knowledge and facilitation to enable effective teams and meetings Communicate and present program status, issues and opportunities to stakeholders Identify critical path issues, risks, resource needs and alternative scenarios to achieve objectives Manage team-level and corporate processes effectively, using strong project and process knowledge to drive team deliverables Apply project management expertise, methodologies, and department standards Contributes to the functional excellence of Regulatory project management by participation in the development and continuous improvement of processes, procedures, and tools related to program and portfolio management practices Requirements: Requires a BS degree, advanced degree preferred, in life sciences or business-related field Minimum of 4 years in a project management function, and 2 years in a pharmaceutical or biotechnology environment Demonstrated understanding of Regulatory and/or drug development processes Excellent customer service skills, which enable successful collaboration with stakeholders Strong organizational, project and time management skills Effective communication skills, both written and verbal Takes accountability for all project management aspects and works collaboratively with team leader Expert use of interpersonal skills and influence to accomplish work without formal authority and to ensure optimal team performance Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders Sound judgment, problem solving, matrix management, and collaboration in selecting methods and techniques for obtaining solutions to problems Solutions-oriented with strong problem-solving skills Ability to work effectively with cross-functional teams in a highly matrixed organization Demonstrated experience coordinating interdisciplinary teams Experience with MS Office programs, and Microsoft Project (preferred) As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113684611

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Finance & Accounting . Bothell, Washington Description Summary: Seattle Genetics, located in Bothell, WA, is seeking a payroll professional who has multi-state payroll processing experience. You will be responsible for the accurate and timely processing, calculation, payment, recording, filing, reporting of multi-state, Canada payrolls and respective payroll taxes for salary and hourly employees in accordance with company policies and procedures, employment laws and regulations, and tax regulations (federal, state and local). As an ideal candidate, you will be able to demonstrate attention to detail, the ability to develop positive working relationships, and a desire for professional growth. This position will also serve as a technical resource for the Payroll team and assist with the implementation of a new Payroll system. Responsibilities: Process multiple state, semi-monthly payroll for 1500+ employees using Ultimate Software Maintain all payroll data, ensuring the highest level of accuracy and confidentiality Research, investigate and resolve payroll discrepancies by collecting and analyzing information Confirm and/or submit quarterly and annual tax reports/statements generated by Ultimate Software (state tax reports, 940's, 941's, W-2's, etc.) Review, reconcile and enter timesheet corrections for each pay period Follow up with Employees for Time and Attendance submissions Maintain, enter and audit new or modified information Respond timely and professionally in response to employee and manager questions and issues Work closely with the HR team Prepare payroll and other journal entries Assists in payroll general ledger accounts reconciliations where applicable Process off cycle pay runs and process manual checks when required Follow policies and procedures; make recommendations for changes in polices/procedures and to increase efficiency Maintain the highest level of confidentiality and protection of all payroll and employee related data/information Assist with implementation of new Payroll system and be a technical resource for team Other duties may be assigned Requirements: 5+ years prior payroll experience Multi-state payroll processing knowledge Familiarity with related Federal and State wage and hour laws Heavy attention to detail required Ability to research, reconcile and resolve payroll discrepancies within tight deadlines Strong organization, communication and problem solving skills Working knowledge of MS Office products with strong proficiency in Excel Additional general accounting experience highly desirable Ultimate Software experience preferred Education: Bachelor's degree or equivalent work experience preferred Certified Payroll Professional (CPP) designation preferred As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113584416

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Commercial . Bothell, Washington Description Summary: The ADCETRIS brand team is looking for an in-line marketing team member to lead the execution of key promotional tactics associated the personal channel, which includes sales, managed markets, programming and other channel related responsibilities. Primary accountabilities of this position will include launch planning, assisting with ADCETRIS brand strategy, definition of channel strategy and tactics, execution of branded and disease education tactics, message development, and sales training facilitation. This position will report to the Associate Director of ADCETRIS Marketing and collaborate closely with senior leadership within Sales, Managed Markets, Market Planning, and other relevant cross-functional partners Responsibilities: Participate in commercial tactical planning and execution for new launch indications for the ADCETRIS brand Contributing to brand strategic decisions based on market research, competitive intelligence, advisory boards, and emerging clinical data Leading tactical projects through the legal, regulatory, and medical review process Partnering with sales organization to deploy and train on brand strategy, messaging, and field tactics Identification and mitigation of critical issues that impact the project timelines Managing program budgets and developing metrics to ensure success of commercial investments Working collaboratively and effectively with all internal and external partners and stakeholders Preparing and presenting key business updates to company Senior and Executive Management Requirements: Bachelor's Degree or equivalent; MBA, Pharm.D., Ph.D. or other related graduate-level degree preferred Minimum of 3 - 5 years of commercial biotech or pharmaceutical experience Oncology experience strongly preferred Demonstrated ability to develop actionable insights from complex clinical data and market research Knowledge of OPDP regulations and FDA promotional policy Strong leadership and ability to influence without authority across functional stakeholders to set direction, align work efforts, and ensure strong execution Working knowledge of product development, regulatory, clinical and medical affairs Ability to establish and foster relationships with key internal and external stakeholders Experience with the management of external agencies as well as project plans and budgets Excellent oral, written and presentation skills Ability to travel approximately 20% of the time As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113584455

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Drug Safety & Pharmacovigilence . Bothell, Washington | South San Francisco, California Description Summary: This position will be responsible for supporting the Safety Evaluation & Risk Management (SERM) lead, or Program Head in the signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seattle Genetics, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Drug Safety department and function in a company matrix team environment interacting with several key internal stakeholder groups including; Development-Clinical Research, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal. Responsibilities: May represent Drug Safety in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues Review and provide analysis for the support of key study-related documents, e.g. IB, ICF, SMC/IDMC Provide SERM lead support in protocol development to ensure alignment with the current development product adverse event profiler, risk management plans and effective collection of safety data May represent SERM in data standards committee Participate in the Signal Management System with supervision from the SERM lead or Program Head, with regular review of safety data for assigned products for identification and evaluation of new safety signals Support safety data review - to include individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources May support medical review of individual safety reports from clinical trials or post-marketing sources Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR) Participate in production and maintenance of risk management plans and safety communication (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties Requirements: MD (board certified/board eligible or ex-US equivalent) Proficiency in use of Excel and Microsoft Office Minimum 3 years of relevant safety pharmacovigilance training in a pharmaceutical company. Oncology safety science experience preferred Clinical research experience desired Exposure to clinical data collection, assessment and analysis Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally Excellent written and spoken English As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113584502

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Clinical Development Operations . Bothell, Washington | Seattle, Washington Description Summary: The CDA II is capable of leading Data Management aspects of a clinical study with some support and oversight. The CDA II has a working knowledge of FDA regulations and general industry standards and supports departmental infrastructure development. Responsibilities: Manage/coordinate work performed by vendors/CROs as appropriate to ensure quality of product With minimal oversight, develop DM documents including but not limited to DMPs, CRFs, CRF Completion Guidelines, Edit Checks, UAT specifications, centralized monitoring plans, data flow and integrity plans, blinding plans, and data review plans Run SAS programs, review SAS logs, and generate output. Program SAS Non System Edit Checks (NSECs) and/or SAS Data Listings as appropriate for SAS skill level With minimal oversight, lead data cleaning activities such as but not limited to Study Team data reviews, Non-system Edit Check Output review, SAE reconciliation, and non-CRF data reconciliation With minimal oversight, manage the database lock process in an efficient and timely manner DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports, experience, knowledge, and other resources to efficiently lead and coordinate all data management activities. Ensure study team members from different functional areas understand and deliver components affecting data to ensure successful execution of deliverables. Provide solutions for data management issues that arise during study conduct Perform medical coding utilizing MedDRA and WHO-DRUG, as appropriate Develop and assist in maintenance of department tools, templates, guidelines, SOPs, and systems Demonstrates "everyday leader" qualities Qualifications: BA/BS in relevant field and 2-5 years experience. Years of experience may substitute for education Requires effective organizational and communication skills Technologically savvy; quickly picks-up new information, standards, regulations, tools, methods or software as it relates to position and profession Detail oriented; performs quality and accurate work Thorough knowledge of FDA regulations and ICH GCP guidelines and the DM Lifecycle Subject matter expertise may substitute for broader DM lifecycle knowledge Preferred: Previous experience with RTSM/IWRS and ePRO systems. Database development experience SAS programming experience Knowledge and understanding of DM Lifecycle associated with P1-P3 studies, including pivotal, blinded, and randomized trials Previous relevant EDC experience Previous vendor/CRO management As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113584559

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Sales . US Field Based Description Summary: The Division Manager will be accountable for attaining sales forecast goals across all territories within the division, which includes the states of new New York, Connecticut, Massachusetts, New Hampshire, and Maine. They will lead a team of high performing Sales Representatives as well as manage all account activity within their division. The Division Manager will provide motivational leadership and strategic direction to the Sales Representatives in order to achieve performance objectives. Responsibilities: Recruit, coach, develop and retain top performers in their respective division Set ambitious division goals and identify strategic business opportunities Develop and execute a tactical business plan for division Ensure all goals for division are met or exceeded; perform quarterly business reviews and provide leadership and strategic direction to Sales Representatives in order to achieve performance objectives Work with Sales Representatives in division on a consistent basis, evaluating their interaction with key customers, providing them with coaching and feedback on sales presentations Work collaboratively with other Division Managers, serve as a resource within the region and leverage the expertise of others Ensure the needs of all internal and external customers are being met by building relationships and delivering innovative solutions Work closely with Sales Director, peers and the home office to achieve sales objectives Assist in development of division budgets and continue to evaluate and ensure fiscal targets are met Qualifications: Bachelor's degree Minimum of 5 years' experience in pharmaceutical sales or healthcare; must have at least 3 years leading oncology Sales Representatives in field sales Demonstrated leadership, communication and presentation skills Proven record of high performance, consistent results and development of sales representatives Oncology experience is required Breast Cancer experience is highly preferred Oral Oncolytic experience is highly preferred Strong knowledge of hospitals and hospital selling preferred Sales Training, Sales Operations or Marketing experience is a plus Thorough understanding of customer segments and division market dynamics within therapeutic area Previous experience in a startup organization a plus Previous launch experience preferred 60% Travel required Some nights and weekends required As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113555670

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Process Sciences . Bothell, Washington Description Summary: Seattle Genetics is seeking a Research Associate to participate in the development of drug programs in a high-throughput core lab. Responsibilities: Conduct experiments, process/analyze data and report results to relevant parties to support manufacturing process development. Requirements: 0-5 years of protein analytical experience in the academic setting or biotechnology/pharmaceutical industry Fundamental knowledge of protein chemistry and knowledge related to the detection of protein posttranslational modifications and chemical degradations using bioanalytical techniques Skills including hands-on analytical experience with some HPLC, electrophoretic and other analytical methods (e.g. SEC, RP, CEX, CE-SDS, iCIEF) will be preferred Strong organization and time management skills with attention to detail and desire to achieve team and individual goals Education: BS or MS in pharmaceutical chemistry, chemistry, biochemistry, biological sciences or a related discipline As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113555687

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Facilities & Engineering . Bothell, Washington | Bothell, Washington Description Summary: The Instrumentation Technician supports the Facilities & Engineering team. The Instrumentation Technician is responsible for performing calibrations, repairs, installations, troubleshooting and documentation of instruments used in GMP, GLP, R&D laboratories, utilities systems and GMP manufacturing plant. This position reports to the GMP Equipment Supervisor, Facilities & Engineering. This position is classified as essential personnel and as such, is required to work with minimal amount of absences and during all site closures as required except in the event of a major disaster when access to the facilities is prohibited by governmental emergency personnel. Responsibilities: Perform instrument calibrations for process, utility and analytical equipment and systems Troubleshoot and repair site instrumentation and control system issues Perform advanced maintenance and repair activities on equipment and systems used in Manufacturing, Analytical Laboratory or other areas of the Bothell site Support freezer, refrigerator and incubator maintenance Assist in managing and scheduling the vendors performing Seattle Genetics Equipment Maintenance and Calibrations Assist with the equipment enrollment process in the CMMS & Starlims (equipment labeling, parts, tasks, personnel, procedures, measurement data templates, etc.) Ensure activities are accomplished in a safe manner Ensure work is completed in accordance with procedures Ensure work activities are completed correctly Maximize right the first time execution Work in a highly productive and efficient manner to maximize the quantity of activities completed Ensure work is appropriately communicated to system owners and key stakeholders Ensure work order documentation is completed accurately and completely Identify waste, work flow interrupters, and other opportunities for improvement, recommend solutions, and assisting with implementation Identify opportunities to learn new skills and actively participate in development that will improve overall team performance Provide support when required - this may be outside of normal working hours including nights, weekends and holidays Participate in an On-call rotation for equipment monitoring & alarms Requirements: Associate's degree and 2 years of Maintenance or Instrumentation experience OR 2 years in a technical school setting with hands-on experience OR High school diploma / GED and 4 years of Maintenance or Instrumentation experience Education: Associate's degree in Maintenance or Instrumentation and Controls As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113555752

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Sales . US Field Based Description Summary: The Division Manager will be accountable for attaining sales forecast goals across all territories within the division, which includes the states of Florida and Georgia. They will lead a team of high performing Sales Representatives as well as manage all account activity within their division. The Division Manager will provide motivational leadership and strategic direction to the Sales Representatives in order to achieve performance objectives Responsibilities: Recruit, coach, develop and retain top performers in their respective division Set ambitious division goals and identify strategic business opportunities Develop and execute a tactical business plan for division Ensure all goals for division are met or exceeded; perform quarterly business reviews and provide leadership and strategic direction to Sales Representatives in order to achieve performance objectives Work with Sales Representatives in division on a consistent basis, evaluating their interaction with key customers, providing them with coaching and feedback on sales presentations Work collaboratively with other Division Managers, serve as a resource within the region and leverage the expertise of others Ensure the needs of all internal and external customers are being met by building relationships and delivering innovative solutions Work closely with Sales Director, peers and the home office to achieve sales objectives Assist in development of division budgets and continue to evaluate and ensure fiscal targets are met Requirements: Bachelor's degree Minimum of 5 years' experience in pharmaceutical sales or healthcare; must have at least 3 years leading oncology Sales Representatives in field sales Demonstrated leadership, communication and presentation skills Proven record of high performance, consistent results and development of sales representatives Oncology experience is required Breast Cancer experience is highly preferred Oral Oncolytic experience is highly preferred Strong knowledge of hospitals and hospital selling preferred Sales Training, Sales Operations or Marketing experience is a plus Thorough understanding of customer segments and division market dynamics within therapeutic area Previous experience in a startup organization a plus Previous launch experience preferred 60% Travel required Some nights and weekends required As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113555801

Seattle Genetics Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law. Clinical Development Operations . Bothell, Washington | Seattle, Washington Description Summary: Seattle Genetics is seeking a highly motivated Biomarker Data Specialist II to join our Clinical Data Management team. In this role, you will be responsible for managing the process of external data transfers, reconciliation of vendor data with clinical data, coordinating lab vendor start-up, and performing vendor oversight. You are the ideal candidate for this position if you have a strong understanding of clinical laboratory and biomarker testing typical in an oncology setting and are adept at handling lab data. The ideal candidate also possesses a working knowledge of FDA regulations and general industry standards and can support departmental infrastructure development. Responsibilities: Independently oversee laboratory data management procedures including authoring data transfer plans, data review plans and overseeing the transfer, processing and storage of data Utilize templates and standard guidelines to initiate documents while exercising critical thinking and discretion to tailor documents to study needs With minimal oversight, manage multiple project streams, each with their own timelines, objectives, deliverables, and stakeholders. Internal stakeholders may include Clinical Pharmacologists, Biomarker & Bioinformatics scientists, Clinical Specimen Coordinators, Clinical Project Managers and others. External stakeholders may include vendor representatives such as Project Managers, Data Analysts and others Lead and conduct data cleaning activities for vendor data reconciliation. Evaluate options and exercise discretion to choose efficient and effective issues resolution paths Advise and coordinate with clinical project managers, scientists, external vendor contacts, programmers, analysts and other stakeholders regarding timelines and deliverables Create detailed specifications for tabular and unstructured data with minimal oversight by working with various stakeholders to ensure appropriate metadata variables and fit-for-purpose data structure that meets end user needs Run SAS programs, review SAS logs, troubleshoot minor errors, and generate output Demonstrate leadership and problem-solving skills when working with vendors and collaborators to efficiently drive projects forward, overcome challenges and advocate for quality data Provide feedback on contracts and study documents to ensure alignment with stakeholders needs, internal processes and vendor capabilities Support processes and infrastructure for managing external data, including creating templates, flow charts, wikis and other guidance documentation; participate in working groups to develop and implement new processes and applications Investigate and resolve data discrepancies by working with external labs and internal stakeholders, as well as sourcing appropriate resources Assist in maintenance of department tools, templates, guidelines, SOPs, and systems Requirements: 2-7 years of relevant experience BA/BS in relevant field; years of experience may substitute for education Laboratory background and/or strong knowledge of commonly tested biomarkers in the oncology setting; latest and advanced analytical tools and assays Effective project management and time management skills; able to prioritize successfully Prior experience writing specification documents and/or work instructions Proficiency with data sets and Excel, understanding of data relationships and metadata Confident in overseeing vendors and communicating with experts to drive quality deliverables Technologically savvy; quickly picks-up on new information, standards, regulations, tools, methods or software as it relates to position and profession Detail oriented; performs quality and accurate work with minimal oversight Excellent written/verbal communication skills Can identify opportunities for efficiency improvements and simplification, recognizes appropriate resources for deliverables, has effective organizational skills Interpersonal skills; encourages collaboration, is a team player and is cooperative, builds constructive and effective relationships, is approachable, communicates effectively Flexible, easily adapts to change, and is energized by challenges and problem-solving Can learn new skills and knowledge, able to offer new ideas but also willing to adapt style to existing process as appropriate Preferred: Previous Electronic Data Capture (EDC) experience Working knowledge of the clinical drug development process Working knowledge of FDA regulations, ICH GCP guidelines, SDTM, CDISC, database development and UAT Oncology experience and/or working knowledge As the leading employer in our industry in the Pacific Northwest, Seattle Genetics is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seattle Genetics, please visit www.seattlegenetics.com . PI113509048