Senior Director, Cardiovascular and Metabolic Diseases, Clinical Pharmacology Modeling and Simulation

GSK • Waltham, MA

5d • Hybrid

About The Position

GSK is recruiting a senior clinical pharmacology leader for its Clinical Pharmacology and Quantitative Medicine (CPQM) organisation, which aims to be a centre of excellence in Model-Informed Drug Development (MIDD). The position leads the end-to-end application of MIDD across drug development, from first-in-human studies through filing and lifecycle management, and contributes clinical pharmacology strategy and evidence generation. The role works across the cardiovascular and metabolic diseases therapy areas and collaborates with cross-functional and CPQM colleagues to support research and development programs.

Candidates based at the Stevenage site will initially work there; GSK plans to relocate its offices to Cambridge, UK, with the role expected to move in accordance with company timelines. The relocation is currently proposed to take effect by early 2029.

The role involves developing clinical pharmacology and MIDD strategies, coordinating activities across the portfolio, overseeing study designs and regulatory evidence, building partnerships across scientific and operational functions, and representing GSK through scientific publications, conferences, and regulatory engagement.

Requirements

• PhD, MD, or PharmD.
• At least 8 years of industry experience in clinical pharmacology, modelling/simulation, and drug development, applying these disciplines to practical pharmaceutical-industry problems.
• Experience in pharmacometrics and its application to clinical questions in drug development.
• Experience working with senior stakeholders in a cross-functional environment.
• Experience in cardiovascular and metabolic diseases therapy areas.

Nice To Haves

• Demonstrated ability to collaborate in multidisciplinary teams, communicate effectively, take personal accountability, and deliver results on time.
• Evidence of sound judgment in complex situations and adaptability to changing business needs while prioritizing multiple tasks.
• Strong track record implementing MIDD approaches to accelerate patient access to novel therapies and expand therapeutic indications of marketed drugs.
• Strong drive and learning agility to build knowledge of drug-disease systems, symptom progression, standards of care, and trial design.

Responsibilities

• Develop and implement MIDD and clinical pharmacology evidence strategies to reduce risk and accelerate programs, supporting faster development, optimal dosing, regulatory positioning, and business development opportunities.
• Coordinate CPMS activities across and above assets, aligning them with global CPMS/CPQM priorities and senior leadership.
• Collaborate with CPQM peers and cross-functional partners to shape the portfolio and disease-area strategies.
• Build and maintain strong working relationships within and beyond CPMS to maximize scientific and operational impact.
• Approve study designs, analyses, interpretations, reports, and clinical pharmacology regulatory documents across the portfolio.
• Draft and review clinical pharmacology regulatory content to support timely approvals and optimal labelling.
• Maintain knowledge of FDA, EMA, CDE, PMDA, and ICH expectations and incorporate regulatory considerations and best practices into study design and MIDD strategies.
• Capture and share lessons learned and trends to continuously improve CPMS contributions to the R&D pipeline.
• Develop cross-functional networks across CPQM and functions including AI/ML, biomarkers, biostatistics, clinical operations, data science, computational biology, and real-world evidence.
• Promote quantitative approaches in decision-making.
• Raise GSK’s profile in MIDD, clinical pharmacology, QSP, and AI/ML integration through publications, conference presentations, and participation in scientific and regulatory forums.

Benefits

• Annual bonus.
• Eligibility to participate in a share-based long-term incentive program, depending on role level.
• Health care and other insurance benefits for employees and their families.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree