Director, Quantitative Clinical Pharmacologist

Key Responsibilities:
- Contribute to the design of an efficient clinical development program, robust registration package, and support life cycle management of an asset.
- Apply Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles to drug development, risk management, and registration.
- Predict human dose range; characterize exposure-response relationships; justify dose recommendations for special populations.
- Develop mathematical models for disease progression and drug PK/PD; conduct meta-analyses for data re-use; run simulations to assess trial design performance.
- Present model-based strategy and outcomes to governance boards and regulatory agencies.
- Apply appropriate FDA and ICH guidelines in clinical study design and drug development strategy.
- Promote model-informed drug discovery and development (MID3) via collaboration, journal publication, and conference presentations.
- Design and interpret clinical pharmacology studies to assess intrinsic/extrinsic factors on PK/PD.
- Use in silico PBPK approaches to explore DDI and special populations where appropriate.
- Write sections of clinical development and registration documents (e.g., trial protocols/reports, clinical investigator brochures, regulatory submission packages).
- Learn and apply emerging modelling/simulation methodologies to enhance program efficiency and decision quality; collaborate with external experts.
- Innovate through effective collaboration with matrix teams (statisticians, biologists, physicians, drug metabolism scientists).

Basic Qualifications:
- PhD, PharmD, or MD (or equivalent advanced degree in life sciences).
- 5+ years’ experience in clinical pharmacokinetics, modelling & simulation, and model-informed drug development (designing, analyzing, and reporting clinical studies).
- Pharmacometric experience for Oncology assets, including ADCs.
- 2+ years’ experience with PK/PD principles and commonly applied models.
- 1+ year’ hands-on experience with tools such as NONMEM, R, WINNONLIN, SIMCYP, SAS, and MATLAB.
- 1+ year’ experience with regulatory submission documents (CTAs, INDs, NDAs, MAAs, BLAs) via regulatory involvement.
- 1+ year’ experience applying FDA and ICH guidelines to clinical development plans and studies.

Preferred Qualifications:
- Expertise in modelling/simulation and/or vaccines/infectious disease therapeutic area.
- Knowledge of infectious disease mechanisms, endpoints, progression, and treatments.
- Strong oral and written communication.
- Ability to collaborate and take personal accountability for quantitative clinical pharmacology delivery.
- Sound judgement, analytical mindset, problem-solving; ability to multi-task and deliver on time.

Benefits (if listed): Annual bonus; share-based long-term incentive; health care/insurance (employee and family), retirement benefits, paid holidays, vacation, paid caregiver/parental and medical leave.

Application Instructions:
- If you require accommodation or assistance to apply, contact Recruitment Staff at usrecruitment.adjustments@gsk.com.