Associate Director, Safety Epidemiologist

Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Position Summary:

The Associate Director, Safety Epidemiology reports to VP Safety Operations & Epidemiology in the Global Safety Risk Management department and has the primary responsibility to lead, conduct, deliver and communicate epidemiology analyses from local, regional, and global sources in support of Seagen’s GSRM and Clinical Development organizations. The scope of activities includes, but is not limited to, medical products under development or post-marketing, post-authorization studies, clinical trial diversity, population sizing and other approved analyses.

Principal Responsibilities:

• Provide epidemiology support to GSPLs in responding to Request for Information (RFI) from regulatory authorities, affiliates, and other cross-functional teams as requested
• Contribute to epidemiology content of clinical protocols and study reports as requested
• Act as the main point of contact for receipt of epidemiology queries/requests and ensure full delivery and communication of outputs to GSRM and Global Development teams
• Receive, evaluate, clarify, conduct, present and archive results of epidemiology analyses. May use external services to complete such analyses if they meet pre-approved criteria
• Provide support to Epidemiology content of documents, including Risk Management Plans, regulatory submission and approval documents, Pediatric Safety Plans, and Diversity Plans
• As an epidemiology expert:
  • Act as the main point of contact for receipt of epidemiology queries/requests and ensure full delivery and communication of outputs to GSRM and Global Development teams
  • Provide support to Epidemiology content of documents, including Risk Management Plans, regulatory submission and approval documents, Pediatric Safety Plans, and Diversity Plans
  • Provide epidemiology consultation to the Safety Evaluation and Risk Management (SERM) team. This may include reviewing, summarizing, and presenting results of aggregate literature data
  • Contribute to epidemiology content of clinical protocols and study reports as requested
  • Provide epidemiology support to GSPLs in responding to Request for Information (RFI) from regulatory authorities, affiliates, and other cross-functional teams as requested
  • Receive, evaluate, clarify, conduct, present and archive results of epidemiology analyses. May use external services to complete such analyses if they meet pre-approved criteria
  • Support epidemiology plans and strategies for Seagen products as requested by Safety and/or Development project teams
• Provide epidemiology consultation to the Safety Evaluation and Risk Management (SERM) team. This may include reviewing, summarizing, and presenting results of aggregate literature data
• Support epidemiology plans and strategies for Seagen products as requested by Safety and/or Development project teams

• Provide oversight, including management of project timelines, budget, and quality of deliverables from external epidemiology vendor(s)
• Contribute to other assigned projects and internal initiatives as requested by SERM or GSO Leadership
• Collaborate with Seagen cross-functional resources, including Health Economics and Outcomes Research (HEOR), Biometrics, Library, and IT as needed to complete epidemiology analyses efficiently and in a timely manner

Qualifications:

• Oncology therapeutic area experience is preferred
• Experience in managing projects independently or with minimal supervision
• 6 years of experience in Global Safety Risk Management, Clinical Safety, Pharmacovigilance or Risk Management preferred
• Good Knowledge of US and EU drug safety and pharmacovigilance regulations
• Sound medical and scientific judgment, attention to detail and excellent interpersonal skills, including the ability to work effectively cross-culturally and cross-functional
• Familiarity and working knowledge of external data sources such as Claims Data, and electronic medical records such as Flatiron
• Experience as a safety epidemiologist

Education:

• Additional degree or certification program in pharmaceutical sciences preferred
• MD, PharmD, or equivalent health science degree from accredited university
• PhD Epidemiology

As the leading employer in our industry in the Pacific Northwest, Seagen 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 Seagen, please visit www.seagen.com.

The hiring pay range for this position is $175,000 - $227,000 per year based on skills, education, and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

Seagen 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.
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