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Senior Medical Director Safety Evaluation and Risk Management

Employer
Seagen
Location
Bothell, Washington State
Salary
Competitive pay, 401k, Medical/Dental/Vision benefits
Closing date
Jul 30, 2022

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Position
Medical Director
Category
Biotechnology
Hours
Full Time
Education
MD, MD / PHD
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Job Details

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

This individual will serve as a member of the Global Safety Risk Management 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. 

Responsibilities:  

  • Provide oversight for 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 regarding safety matters and issues  
  • Lead Safety Management Team for assigned pre-marketing and/or post-marketing product(s) and all associated risk management activities  
  • Participate in 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 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 protocol development to ensure alignment with risk management plans  
  • Review and provide medical content, as needed, for key study-related documents, e.g. IB, ICF, SMC/IDMC Charters  
  • Contribute to analysis of safety data from on-going and completed clinical trials and presentation in Clinical Study Reports  
  • Facilitate 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  
  • Participate in continuous improvement activities including systems design, performance measurement and quality management  
  • Provide guidance and mentorship to staff on pharmacovigilance and risk management best practices and safety science  
  • Provide input to Pharmacovigilance agreements and interactions  
  • Participate in alliance safety teams with external partner(s) 

Qualifications:  

  • MD (board certified or ex-US equivalent)  
  • Minimum of 3 years (Director) experience in Drug Safety, Clinical Safety, Pharmacovigilance or Risk Management  
  • Oncology safety science experience preferred  
  • 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  
  • Excellent written and spoken English  
  • Prior experience with business partners a plus 

 

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. 

Company

Seagen is a global biotechnology company that develops and commercializes transformative cancer therapies. We’re driven by a singular mission—to make a difference for people impacted by cancer.

As an industry leader in antibody–drug conjugate (ADC) technology, we pioneered the science of harnessing antibodies designed to deliver cell-killing agents to cancer cells. Three of our four approved medicines are built on this technology.

We also focus our research efforts on novel targeted small molecule therapies. In addition, we are leveraging our expertise in empowered antibodies to build a portfolio of proprietary immuno-oncology agents.

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