Executive Director, Pharmacometrics Head

Role Summary

Executive Director, Pharmacometrics Head leads the pharmacometrics strategy across the early and late phase clinical portfolio, driving model-informed drug development, automation, and AI-enabled decision making within DQS and QPTS. The role encompasses cross-functional leadership, regulatory representation, and external engagement to advance the portfolio and scientific capabilities.

Responsibilities

• Leads and drives a team of in-house pharmacometricians to deliver all pharmacometrics analyses internally and externally to support the clinical portfolio and business development activities.
• Maintains a network and strong relationship with external vendors to support regulatory pharmacometrics analyses.
• Operates at an enterprise level, defines, leads and drives cross-therapeutic area and platform level pharmacometrics strategies to advance the portfolio through decision-making milestones; seeks opportunities to extend MIDD approaches beyond drug development to decisions impacting product valuation and reimbursement.
• Leads and drives the evolution of in-house modelling platform capabilities with a vision of increased automation, integration of emerging data sources, program-level clinical trial data, and use of AI with an end-to-end mindset and process, in compliance with GxP.
• Collaborates with colleagues in DMPK&M to enable the transition and implementation of mechanistic modelling (PK-PD, PBPK-PD, QSP) into the clinical portfolio as assets progress through IND, enriching understanding and opportunities, populations, dosing, and trial design optimization.
• Key driver of pharmacometrics strategies, including Model-Informed Drug Development (MIDD) as part of the QDM framework, integrating pharmacometrics plans in collaboration with QCP and SQS.
• Represents Pharmacometrics in global or regional regulatory agency meetings and is responsible for the technical component of clinical pharmacology summary documents for regulatory submissions.
• Maintains high standards for good clinical practice, compliance, and ethics.
• Participates in Business Development due diligence, providing fit-for-purpose evidence-based risk assessments in a timely manner.
• Promotes and drives the Pharmacometrics vision and mission, identifying opportunities and delivering for the DQS mission to make R&D business impact.
• Acts as a role model to members of QCP and DQS; demonstrates cross-functional leadership and collaboration.
• Demonstrates leadership in scientific societies and cross-industry consortiums related to pharmacometrics work streams.

Qualifications

• Required: Pharm D. or PhD with 15+ years of working experience in a quantitative field with extensive pharmacometrics, mechanistic modelling, statistics or chemical bio-engineering, and substantial management/leadership experience.
• Required: MS with 18+ years' working experience in a quantitative field with extensive pharmacometrics, mechanistic modelling, statistics or chemical bio-engineering, and substantial management/leadership experience.

Skills

• Established Subject Matter Expert in multiple areas internally or externally, including leadership of internal or external focus groups.
• Robust understanding of pharmacology and statistical principles.
• Recognized expert in pharmacometrics and clinical pharmacology with emphasis on AI and automation.
• Ability to define and lead cross-therapeutic strategy, directing and overseeing complex pharmacometrics analyses in partnership with DQS functions and external partners.
• Drives innovative strategies and influences business-critical decision-making beyond QCP/Pharmacometrics responsibilities.
• Solid mathematical and pharmacological/mechanistic background and training.
• Extensive experience in R&D cross-functional strategy from candidate selection through life-cycle management; HA interactions and submissions.
• Extensive experience implementing MIDD strategies as part of global filings and approvals.
• Drives efficiency and cost-effectiveness in drug development through robust pharmacometrics planning and innovative methodologies.
• Ability to evaluate benefit-risk and manage expectations across projects/assets/franchises and therapeutic areas.
• Ability to establish external networks to facilitate collaborations across industry, government, and academia.

Education

• Pharm D. or PhD with 15+ years of experience in pharmacometrics, mechanistic modelling, statistics or related quantitative field, with strong leadership background.
• MS with 18+ years of experience in pharmacometrics, mechanistic modelling, statistics or related field, with strong leadership background.