Senior Director - Clinical Biomarkers and Diagnostics

Development Bothell, United States


Description

Position at Seagen

Seagen is currently offering a unique opportunity for a highly motivated individual to lead the development of clinical biomarker strategic planning and implementation for our pipeline of targeted cancer therapies. The successful candidate must possess a deep understanding of clinical biomarkers including critical and related pathways, early assay development, regulatory compliance for biomarker testing, the use of biomarkers to support patient selection strategies and inform drug development. While the primary role of this position will focus on the development and clinical implementation of a clinical biomarkers, the ideal candidate will also provide scientific and strategic input to support efficient decision making for our ongoing clinical trials. As an advisor to development project teams, as well as research and translational and commercial subteams, they will have the opportunity to work in a highly collaborative environment and to support projects throughout clinical development. The Senior Director will recruit and manage the Clinical Biomarker Team Subfunction and be responsible for the professional development of these team members.



Principal Responsibilities

  • Develop and deliver an overarching clinical biomarker strategy, including integrating biomarker and related testing into pipeline development and supporting accelerated approval development plans
  • Develop strong relationships with preferred partners, contribute to partnership negotiations, ensure the development of high-quality work plans and data packages for clinical biomarker strategies
  • Manage and develop the Clinical Biomarker group within CBDx   
  • Contribute to the development of global regulatory submissions, respond to health authority questions, review labeling documents and significant risk determinations as needed
  • Function as a scientific thought leader for clinical biomarker strategies and implementation
  • Lead and provide subject matter expertise to the use of clinical biomarker testing in understanding dose selection, indications and supporting patient selection strategies
  • Provide expertise to R&D, clinical development, and regulatory teams on biomarker strategies as related to key programs
  • Manage clinical biomarker strategy and testing through commercial launch
  • Must be able to work in fast paced work environment and participate on cross-functional teams in selecting methods, techniques and evaluation criteria to achieve business results.

 

Qualifications

  • Candidates must have a PhD with relevant industry experience
  • Demonstrated experience in the use of clinical biomarkers in oncology clinical trials and drug development including in depth knowledge of critical biomarkers, implementation of biomarker strategies, clinical validation and utilization of biomarkers in oncology
  • Broad understanding of clinical development process and regulatory approval process of cancer therapies and where biomarkers fit
  • Proven scientific/leadership expertise including the successful management and development of a highly skilled team
  • Team management experience and cross-functional collaboration required
  • Excellent verbal and written communication and presentation skills
  • Minimum of 10 years experience in industry or related setting.