Associate Medical Director SERM

Development Bothell, United States


Description

Position at Seagen

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! 

Summary: 

This position will be responsible for signal detection and aggregate safety assessment for global pharmacovigilance and risk management for assigned Seagen, Inc. investigational and/or marketed products. The successful candidate will serve as a member of the Global Safety Risk Management department 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, Research and Legal. 

 
Principal Responsibilities: 

  • Represent Global Safety in Clinical Sub Team and Study teams for assigned investigational products providing expert medical guidance regarding safety issues 
  • Responsible for signal validation, developing strategy on signal evaluation, interpreting safety results, presenting signal assessment and proposed actions to multidisciplinary global safety teams and safety governance 
  • Develop search strategies for AESI, and signal detection plan,   
  • Contribute to submission activities involving safety related topics, safety data presentation strategies, safety data review, safety document review 
  • Contribute to label development 
  • Draft responses to safety queries from health authorities or IRBs 
  • Review and provide analysis for the support of key study-related documents, e.g., IB, Risk Profiles, ICF, SMC/IDMC 
  • Participate in protocol development to ensure alignment with risk management plans and effective collection of safety data 
  • Participate in the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals 
  • Responsible for safety data review - to include individual case review and aggregate safety assessment and analysis using safety data from clinical trials or post-marketing sources 
  • Perform/provide oversight for 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 
  • Represent Global Safety in data standards committee 
  • Contribute to department initiatives/projects 
  • Supports and contributes to activities for a product registrational filing 

Qualification: 

  • 7 years of relevant experience in Global Safety Risk Management, Clinical Safety, Pharmacovigilance or Risk Management preferred 
  • Clinical research experience with exposure to clinical data collection, assessment, and analysis desired 
  • Oncology safety science experience preferred 
  • Prior experience with business partners a plus 
  • Knowledge of ICH, US & EU regulations, and requirements for pharmacovigilance (experience with world-wide safety reporting regulations and guidelines required) 
  • Excellent interpersonal skills, including ability to work effectively cross culturally and cross functionally 
  • Proficiency in use of Excel and Microsoft Office 
  • Excellent written and spoken English 

Education:  

  • Medical/clinical degree (board certified/board eligible or ex-US equivalent), PhD in a relevant area, PharmD, MPH/MSN, or BSN degree 

 

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.  

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.  

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law. 

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