Executive Medical Director, Safety Evaluation & Risk Management
The Executive Medical Director, Safety Evaluation & Risk Management (SERM) will be responsible for leadership of a program (or programs) within the Risk Management & Pharmacovigilance Department. He/she will provide high quality medical safety/PV expertise, strategic thinking leadership for the Pharmacovigilance and Benefit Risk Assessment of Seattle Genetics’ products throughout the lifecycle. He/she will manage the physicians and scientists in the SERM group who perform signal detection, aggregate review, and overall benefit/risk assessments and management for Seattle Genetics marketed products and clinical development compounds on a global basis. In addition, he/she will be responsible for day-to-day oversight of at least one Seattle Genetics’ product. This individual will serve as a member of the Drug Safety leadership team and function in a company matrix team environment interacting with several key internal stakeholder groups including; Clinical Affairs, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal.
- Establish/enhance robust surveillance and benefit-risk processes based on clinical and scientific expertise to support Seattle Genetics’ products across the lifecycle
- Provide oversight for members of the Safety Evaluation and Risk Management (SERM) group in Drug Safety
- Management of physicians and scientists in the SERM group including recruitment, training, mentoring and development
- Establish risk management process starting early in development. Work with clinical teams to develop risk management plans to support Seattle Genetics’ regulatory submissions
- Oversee signal management and risk management of Seattle Genetics’ products on a global basis across the life cycle
- Work with clinical counterparts as needed, including review clinical study protocols, development plans and serious adverse event handling
- Communicate and interact effectively within and across therapeutic teams, and within functional team management as appropriate
- Provide pharmacovigilance support for internal and external customers
- Provide medical and scientific expertise on pharmacovigilance matters affecting the preparation and submission of timely and accurate information to the regulatory authorities
- Work with labeling team to accurately portray the safety profile of assigned drugs or biologics
- Provide the training, leadership and continuing education for all departmental staff
- Liaise with clinical/medical counterparts across the business to provide PV expertise as needed.
- Contribute to preparation and review of periodic reports (PADER; PSUR; Annual IND report; 6-monthly line-listings; EU Annual Safety Report; DSUR)
- Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters
- Provide input to Pharmacovigilance agreements and interactions
- Participate in alliance safety teams with external partner(s)
- Participate in protocol development to ensure alignment with risk management plans
- MD (board certified or ex-US equivalent)
- Minimum of 7 years’ experience in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management
- Oncology safety science experience preferred
- Extensive knowledge of current and emerging regulatory requirements and expectations including EMA GVP Modules, FDA IND and NDA reporting requirements, global risk management requirements, ICH, CIOMS
- Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally
- Experience communicating, meeting with FDA, EMA and other global regulatory authorities
- Excellent oral and written communication skills
- Excellent teamwork and interpersonal skills are 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.
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.