Pharmacometrics Director | Leading Global Biopharmaceutical Company | Boston, MA

About the position

Pharmacometrics Director search is being conducted on behalf of our global biopharmaceutical client who is pushing the boundaries of science to deliver life-changing medicines. They are resetting expectations of what a biopharmaceutical company can be. They are opening new ways to work, groundbreaking and cutting-edge methods and bringing unexpected teams together. As a Senior Director, you will be responsible for developing a culture supportive of MIDD approaches within the TA, planning and executing state-of-the-art modeling and simulation (M&S) techniques, providing scientific and strategic input into pre-clinical, clinical, and post-approval development plans, and much more. This individual will delegate for the TA Head at functional and cross-function M&S and quantitative science meetings and initiatives as required.

Responsibilities

• Develop a culture supportive of MIDD approaches within the TA.
• Plan and execute state-of-the-art modeling and simulation (M&S) techniques.
• Provide scientific and strategic input into pre-clinical, clinical, and post-approval development plans.
• Accountable for the scientific strategy and quality of modeling & simulation (M&S) and other pharmacometrics (PMx) activities within the oncology TA.
• Apply state-of-the-art M&S approaches to influence clinical study designs and internal/external decision making across the portfolio.
• Delegate for the TA Head at functional and cross-function M&S and quantitative science meetings and initiatives.

Requirements

• PhD degree or equivalent (MSc/PharmD) required with relevant experience.
• Significant demonstrated expertise within the field of modeling and simulation including PK, PKPD and statistics.
• Demonstrated broad translational and clinical development expertise and experience exemplified by at least 10 years international drug development experience (early and late), with emphasis on Pharmacometrics.
• International scientific reputation gained from scientific publishing in the field on pharmacometrics.
• Demonstrated ability to identify, develop and execute strategic M&S activities at level of portfolio.
• Significant disease domain knowledge.
• Demonstrated knowledge of regulatory, compliance, processes, standards and issues specific to pharmacometrics.
• Strong leadership capabilities, including influencing skills.
• Expert knowledge about relevant software and tools within the field of M&S.