Vice President – Clinical Pharmacology & Pharmacometrics

Vice President – Clinical Pharmacology & Pharmacometrics

Requirements

• Ph.D. in relevant fields or equivalent training with 15+ years progressive industry experience in clinical pharmacology, pharmacometrics, or related technical areas.
• Deep knowledge in clinical pharmacology, broad translational and clinical development experience with track records in building and leading a high-performing Clinical Pharmacology and Pharmacometrics teams that drive strategic outcomes in support of oncology drug development.
• Significant experience with development of overall Clin Pharm strategy and operational management of plans with cross-functional teams.
• Proven performance in comparable role including strategic oversight and stakeholder management across levels internally and externally.
• Innovative attitude coupled with a strong sense of practical execution.
• Well-informed in current and emerging scientific standards of regulatory requirements and expectations.
• Excellent verbal and written communication skills, and ability to clearly convey complex concepts and findings to both non-specialist and specialist audiences.
• Strong interpersonal skills, ability to work collaboratively with cross-functional leadership team to influence development project and management teams.
• A critical thinker and passionate team player with high energy who thrives in a dynamic and fast-paced environment.

Responsibilities

• Serve as a trusted advisor to project teams and governance committees and act as a thought partner to impact cross-functional development strategies.
• Define the end-to-end Clinical Pharmacology strategy and drive fit-for-purpose execution, ensuring deliverables are timely, decision-enabling, and integrated with the overall clinical development and registration plan, to support corporate goals.
• Champion model-informed drug development approaches to accelerate decision-making from phase 1 through registration. Oversee the implementation of efficient modeling and simulation strategy, 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.
• Oversee DMPK and Clin Pharm in identifying, proposing timing and design for dedicated clinical pharmacology studies (e.g., rBA/BE, DDI, special population, human ADME, and TQT etc.) to support clinical development and registration, and collaborate with clinical operations to effectively oversee, contract, and manage the execution of these studies.
• Oversee authoring of relevant sections/modules of regulatory documents (including INDs, IBs, CTAs, IMPDs, NDAs, briefing packages, or other regulatory dossier) and participate in interactions with regulatory authorities.
• Lead and oversee departmental systems/processes and ‘best practices’ for effective delivery and ensure internal team stays current with relevant regulatory guideline for compliance.
• Drive and foster innovation and adoption of emerging technologies and approaches to drive critical Clin Pharm deliverables.
• Lead short- and long-range planning, annual budgeting and reforecasting activities for Clinical Pharmacology and Pharmacometrics. Monitor and manage budgets for the function.
• Drive and lead staff management strategies and processes focused on scalable growth, effective organizational design, employee engagement and performance optimization; provide ongoing feedback and coaching to support professional development while aligning individual aspirations and business objectives.

Preferred Qualifications

• Progressive industry experience in clinical pharmacology and pharmacometrics.