Medical Director Safety Evaluation & Risk Management

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: 

The (Medical) Director, Safety Evaluation & Risk Management (SERM) will be responsible for strategic and innovative medical leadership for global pharmacovigilance and risk management activities for assigned Seagen, Inc. investigational and marketed products. 

This individual will function in a company matrix team environment interacting and leading with decisional ability with several key internal stakeholder groups including Clinical Development Medical Affairs, Regulatory Affairs, Product Quality Compliance, Quality Assurance, Commercial, Translational & Experimental Medicine and Legal. 

Principal Responsibilities:  

  • Provide oversight and empowers decision-making from members of the Safety Evaluation and Risk Management (SERM) group in Global Safety Risk Management 
  • Represent Global Safety Risk Management in Clinical Sub Team for assigned investigational products providing expert medical guidance in planning and gaining alignment for all safety matters and issues 
  • Lead Safety Management Team navigating complex safety issues, despite ambiguity, for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities 
  • Provides insightful guidance regarding the Signal Management System with regular review of safety data for assigned products for identification and evaluation of new safety signals 
  • Perform/provide oversight for medical review for causality assessment 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; Product Quality Report) 
  • Contribute to protocol development ensuring alignment with risk management plans 
  • Review and contribute medical content, as needed, for key study-related documents, e.g., Risk Profile, IB, ICF, SMC/IDMC Charters 
  • Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports 
  • Contribute, assure quality, support production, and assure maintenance of risk management plans and safety communication in partnership with Regulatory Affairs (marketing applications, company core safety information, regulatory safety queries, etc.) to regulatory agencies or third parties 
  • Participate in continuous improvement activities including systems design, operational and business processes, performance measurement and quality management 
  • Provide guidance, and mentor staff, supporting their career goals, as well as building on pharmacovigilance and risk management best practices and safety science 
  • Provide input to Pharmacovigilance agreements and interactions 
  • Contributes, is innovative and persuasive in navigating safety concerns/issues to closure in alliance safety teams with external partner(s) 
  • Champions and is agile & strategic in driving results cross-functionally, meeting, or exceeding project timelines  
  • Contributes/leads special projects with organizational impact  
  • Contributes and leads activities required for a product registrational filing 

Qualifications:  

  • 8 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 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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