Associate Director Clinical Pharmacology

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 Associate Director of Clinical Pharmacology will have exceptional technical and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance development of novel oncology drug candidates across various stages of development for multiple modalities including monoclonal antibodies, ADCs and small molecules. This individual will be responsible for the development and implementation of clinical pharmacology and M&S strategies to ensure that the right drug is delivered to the right patient at the right dose and schedule by integrating data from within the department and in collaboration with the Research and Development departments. 

Responsibilities: 

  • Work in close collaboration with key stakeholders, define and execute clinical pharmacology and M&S strategy for novel oncology drug candidates 
  • Represent the clinical pharmacology function on development project teams and take accountability for clinical pharmacology deliverables 
  • Conduct PK/PD and exposure-response analyses using pharmaco-statistical and relevant state of the art modeling and simulation techniques to support dose selection, trial design, Go/No-Go decisions, regulatory submission documents, and publications 
  • Provide subject matter expertise to inform decisions on key scientific questions 
  • Provide key guidance on regulatory strategies, and present data and interpretations in written and oral form to regulatory bodies to enable optimal clinical development and registration of novel drugs 
  • Mentoring and supervising junior staff members 
  • Represent Seagen in the external scientific environment – influencing partners and regulators in a positive way 
  • Actively participate in departmental leadership 
  • Build collaborative networks internal and external to the company to ensure rapid and successful development of novel drugs 

 Requirements: 

  • An advanced degree (PhD, MD, or PharmD) with 7+ years of experience in pharmacology, pharmaceutical sciences, pharmacy, biomedical engineering, or other related fields 
  • Expertise in clinical and quantitative pharmacology and hands-on modeling and simulation skills using NONMEM, R, Simcyp, SAS, MATLAB and/or other modeling and simulation software. Experience with advanced mechanistic PK/PD models, disease models, PBPK models, quantitative system pharmacology (QSP) models, clinical trial simulation is highly preferred. 
  • Track record of working with health authorities and responding to regulatory questions and knowledge of global regulatory requirements and guidances on quantitative analyses 
  • Excellent interpersonal, verbal and written communication skills and the ability to function in a highly matrixed team environment 
  • Previous record of impact on drug development through quantitative approaches with strong leadership skills and the ability to influence 
  • Substantial understanding of oncology or related field (e.g., inflammation, immunology). Experience with both large and small molecule therapeutics is preferred 

 

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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