Executive Director, Oncology PK/PD Modeling

GSK; North Carolina; Hybrid; USD 230,000 - 270,000; Full time

Job summary

GSK is seeking an Executive Director in Oncology Clinical Pharmacology Modeling and Simulation to lead CPMS excellence across R&D programs. You will provide scientific leadership for trial design, data interpretation, and cross-functional collaboration with Research, DMPK, and Clinical Pharmacology to advance oncology therapies.

The role requires on-site presence 2-3 days per week and a strong track record in translational pharmacology and trial design within oncology.

Qualifications

• PhD biological/pharmaceutical sciences or related discipline with 15+ years of experience in biotech/pharma or related industry.
• Extensive experience in drug development functions (Nonclinical and Clinical) is required.
• A minimum of 15 years of experience managing matrix teams, external service providers, 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).
• Experience in translational research and clinical pharmacology in ADCs, TCEs, small molecules and antibodies.
• Excellent command of applicable GxPs and standard processes.
• Demonstrated cross-functional understanding related to drug development.

Responsibilities

• Provide advanced technical, therapeutic, and product development support for oncology programs.
• Provide managerial support to CPMS Managers and Directors, applying PK/PD, clinical pharmacology, and MS principles.
• Bridge to clinical pharmacology and modeling/simulation in support of development programs.
• Collaborate to design initial clinical pharmacology studies (e.g., rBA/BE, DDI, special populations).
• Contribute to development of PK/PD modeling strategies and PBPK to support trial design and dosing justification.
• Lead or contribute to regulatory dossier sections (INDs, IBs, briefing packages).
• Participate in meetings with regulatory authorities as needed.
• Implement best practices from internal/external sources to advance CPMS contributions.
• Define and execute a coordinated scientific/technical strategy with an 18–24 month horizon.
• Identify and develop talent, coaching future leadership within CPMS.
• Advise on PK/PD data analysis from nonclinical studies and external data.
• Develop relationships with external parties and stay current on industry trends.
• Other duties as assigned.

Skills

Animal Models

Artificial Intelligence (AI)

Clinical Pharmacology

Drug Design

Drug Discovery Process

Drug Discovery Research

In Vitro Models

Medication Safety

Molecular Modeling

Oncology

Pharmacodynamics

Pharmacokinetics

Pharmacometrics

Pharmacovigilance

Target Validation

Job description

GSK is seeking an Executive Director in Oncology Clinical Pharmacology Modeling and Simulation to lead CPMS excellence across R&D programs. You will provide scientific leadership for trial design, data interpretation, and cross-functional collaboration with Research, DMPK, and Clinical Pharmacology to advance oncology therapies.

The role requires on-site presence 2-3 days per week and a strong track record in translational pharmacology and trial design within oncology.