Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation

About the role

The Executive Director, Clinical Pharmacology supports the Oncology Clinical Pharmacology Modeling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS excellence to research and development programs, accelerating the development of innovative oncology therapies.

Responsibilities

• Provide advanced technical, therapeutic, and product development support for programs with a focus on the Oncology portfolio.
• Provide managerial support to CPMS Managers and Directors.
• Bridge clinical pharmacology to modeling and simulation in support of development programs.
• Collaborate to identify and propose initial design for clinical pharmacology studies (e.g., rBA/BE, DDI, special population, human ADME, and TQT etc.) needed to support clinical development plans, risk assessment, and collaborate with research and development teams.
• Input on development of efficient and effective modeling and simulation strategies, including population PK, exposure-response analysis, and physiologically based PK (PBPK) to support clinical trial design, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions.
• Lead and/or contribute to the authoring of relevant sections/modules of regulatory dossier (including INDs, IBs, briefing packages, or other regulatory dossier).
• Implement best practices, trends, learnings, etc from internal and external sources to further CPMS contribution to R&D pipeline.
• Influence, define and execute a coordinated scientific and/or technical strategy (18-24 months planning horizon).
• Demonstrate cross-functional understanding related to drug development.
• Identify and develop talent, providing appropriate coaching to ensure future leadership/succession plans for the CPMS organization.
• Advise team in the analysis of data, including internally or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical studies.
• Develop relationships with external parties and consortia (and stay current on industry trends and practices).

Qualifications

• PhD biological/pharmaceutical sciences or related discipline with 15+ years of experience in a biotech/life science, pharmaceutical or related industry.
• Extensive experience in drug development functions (e.g., Nonclinical and Clinical).
• A minimum of 15 years of experience managing matrix team, external service providers (worldwide), and consultants.
• A minimum of 5 years of experience in managing talent/direct reports.
• Hands-on experience with clinical PK and PK/PD data analysis; and expertise with advanced modeling and simulation (e.g., Population PK, PBPK).
• Prior experience of translational research and clinical pharmacology in ADCs, TCEs, small molecules and antibodies.
• Excellent command of applicable GxPs and standard processes.
• Demonstration of cross-functional understanding related to drug development.