Senior Director, Clinical Pharmacology & Pharmacometrics

Senior Director, Clinical Pharmacology & Pharmacometrics

This role requires strong scientific, technical, and leadership skills to develop and implement clinical pharmacology and modeling & simulation strategies to advance drug candidates across various stages of development. Working closely with partners from discovery and development, the individual is responsible for providing strategic and technical subject matter expertise as well as scientific oversight for the clinical pharmacology and pharmacometrics support of multiple programs. The Senior Director contributes to the growth of the department and will mentor or manage junior clinical pharmacologists.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop, implement, and/or supervise clinical pharmacology and pharmacometric strategies to drive programs through all stages, from research through post-marketing.
• Serve as the clinical pharmacology lead on multiple project teams, providing subject matter expertise on PK/PD, biopharmaceutics, drug-drug interactions, and quantitative pharmacology.
• Advance small molecules and biologics through key development milestones, including IND/CTA, EOP2, and marketing applications.
• Oversee and/or conduct PK/PD and exposure-response analyses using state-of-the-art modeling and simulation techniques to support human PK predictions, dose selection and optimization, trial designs, risk/benefit assessments, Go/No-Go decisions, regulatory submissions, and publications.
• Collaborate cross-functionally with teams in Clinical Development, Biostatistics, Discovery, Translational Medicine, CMC, Toxicology, DMPK, Clinical Operations, and Regulatory to achieve project and corporate objectives.
• Provide functional area expertise in due diligence evaluations.
• Drive external scientific visibility and publication objectives.
• Evaluate and implement innovative methods to maintain cutting-edge modeling techniques and capabilities.
• Ensure adherence to SHE policies, GXPs compliance, and regulatory standards within clinical pharmacology programs.
• Train and mentor junior staff, fostering an environment of innovation and scientific excellence.

SUPERVISORY RESPONSIBILITIES:

• Supervise staff, including hiring, scheduling, assigning work, performance reviews, salary considerations, promotions, and other personnel decisions.
• Directly oversee full-time employees.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

• PhD in a related discipline with a minimum of 12 years of relevant experience in the pharmaceutical industry; or an equivalent combination of education and experience.

• At least 12 years of experience in clinical pharmacology and pharmacometrics.
• Experience in the development of small and/or large molecules and novel modalities.
• Proven track record supporting drug candidates at various stages of development within the clinical pharmacology function.
• Strong background in utilizing modeling and simulations to advance drug development.
• Experience contributing to IND/NDA/BLA and global marketing applications.
• Oncology therapeutic area experience preferred.
• Contributions to translational science and precision medicine initiatives.

• Expert-level understanding of clinical and quantitative pharmacology principles.
• Strong quantitative skills, including population PK models, mechanistic PK/PD models, disease models, and PBPK models.
• Deep knowledge of regulatory guidance related to nonclinical and clinical pharmacology for both small molecules and biologics.
• Excellent interpersonal, verbal, and written communication skills with the ability to convey complex technical information clearly.
• Strong collaboration skills with cross-functional teams.
• Ability to lead major projects and drive them to successful completion.
• Strong adaptability, problem-solving, and influencing skills in a dynamic environment.
• Demonstrated ability to develop strategic proposals and recommendations while motivating teams to achieve objectives.
• Thrives in a fast-paced business environment.
• Applied knowledge of GLP and GCP regulations.

JOB COMPLEXITY:

• Operates effectively in a highly matrixed team environment.
• Builds collaborative networks across functions.
• Develops innovative solutions to complex challenges.
• Leads and manages high-performance teams.