Director, Oncology Clinical Pharmacology & M&S

GlaxoSmithKline; Waltham (MA); Ibrido; USD 188.000 - 314.000; Tempo pieno

Vantaggi offerti da questo lavoro

Hybrid work schedule

Annual bonus

Long-term incentive program

Health care & insurance benefits

Retirement benefits

Descrizione del lavoro

GSK seeks a Director to lead Oncology CPMS, combining clinical pharmacology and modeling to inform dose selection and program strategy. Hybrid role with 2–3 days in the office, and collaboration across small molecules, biologics, or ADCs.

You will design and interpret PK/PD studies, develop models, and communicate results to project teams and regulatory bodies. Experience with FDA/ICH guidelines and MID3 is essential for impact.

Competenze

• Advanced degree (PhD/MD) in pharmaceutical sciences, engineering, statistics or related field; PharmD or Master’s with experience may be considered.
• 5+ years leveraging clinical pharmacology and modeling in drug development.
• 5+ years applying PK/PD principles and pharmacometric models.
• 5+ years using quantitative pharmacology tools (NONMEM/Monolix/R).
• Experience applying FDA/ICH guidelines in study design and development plans.

Mansioni

• Contribute to design of efficient clinical development programs and robust registration packages.
• Predict human dose range and characterize exposure–response relationships.
• Design and interpret clinical pharmacology studies evaluating factors on PK/PD.
• Develop mathematical models to understand disease and drug kinetics; conduct meta-analyses and simulations.
• Present CPMS strategy and outcomes of model-based approaches to project teams and regulators.
• Write sections for protocols, reports, and regulatory submissions.
• Apply FDA/ICH guidelines in study design and drug development strategy.
• Promote MID3 usage within teams and external collaborations.
• Collaborate across matrix teams to advance program efficiency.

Conoscenze

Clinical pharmacology

Modeling & simulation

Regulatory knowledge

Data analysis

Cross-functional collaboration

Formazione

PhD or MD in Pharmaceutical Sciences

PharmD or Master's with 4 years experience

Strumenti

NONMEM

Monolix

R

Descrizione del lavoro

GSK seeks a Director to lead Oncology CPMS, combining clinical pharmacology and modeling to inform dose selection and program strategy. Hybrid role with 2–3 days in the office, and collaboration across small molecules, biologics, or ADCs.

You will design and interpret PK/PD studies, develop models, and communicate results to project teams and regulatory bodies. Experience with FDA/ICH guidelines and MID3 is essential for impact.