Job Purpose
The Director, Clinical Pharmacology sits within the newly established Clinical Pharmacology and Quantitative Medicine (CPQM) organisation, which aims to be a centre of excellence in Model‑Informed Drug Development (MIDD) by integrating clinical pharmacology, digital medicine, translational imaging and mechanistic/systems modelling. You will lead the end‑to‑end application of MIDD across the drug development lifecycle—from first‑in‑human studies through filing and lifecycle management—and provide clinical pharmacology strategy and evidence‑generation input.
Main Responsibilities
* Design & Execute Model Informed and Clinical Pharmacology strategies; develop and implement robust MIDD & ClinPharm evidence strategies to de‑risk and accelerate RIIRU programs, aiming for faster development, optimal dosing and stronger regulatory positioning across respiratory, inflammation, neurodegeneration and emerging areas; support business development opportunities.
* Ensure robust ways of working and regulatory ready evidence; draft and review clinical pharmacology regulatory content to support timely approvals and optimal labelling; maintain up‑to‑date knowledge of FDA, EMA, CDE, PMDA and ICH expectations and embed regulatory considerations and best practices into study design and MIDD strategies.
* Build cross‑functional partnerships; work closely with CPQM peers (digital medicine, translational imaging, MIDD specialists, mechanistic/systems modelling) and cross‑functional partners (biology, data science, computational biology, clinical, etc.); maintain strong networks, share best practices in the CPMS community of practice, and embed quantitative approaches into decision making at asset level.
* External engagement & scientific leadership; raise GSK’s profile in MIDD, clinical pharmacology, QSP and AI/ML integration through publications, conference presentations and active participation in scientific and regulatory fora to influence method adoption and regulatory dialogue.
Basic Qualifications
* PhD in life sciences or related discipline, MD, or PharmD, with experience in clinical pharmacology, modelling and simulation in pharmaceutical research and development.
* Significant experience in clinical pharmacology, modelling/simulation and drug development to solve practical problems in the pharmaceutical industry.
* Experience in pharmacometrics and their application to clinical questions in drug development.
Preferred Qualifications
* Additional experience in respiratory and immunology would be beneficial.
* Demonstrated experience of collaboration in a multi‑discipline team, using effective communication and taking personal accountability for timely delivery of results.
* Evidenced experience making sound judgement in complex situations and adapting to changing business needs by prioritizing multiple tasks.
* Experience working with senior stakeholders in a cross functional environment.
* Track record of implementation of Model‑Informed Drug Discovery and Development (MIDD) approaches to accelerate patient access to novel therapies and to expand therapeutic indications of marketed drugs.
* Drive and learning agility to build knowledge on a drug‑disease system, symptom progression, standard of care, and trial design.
Salary and Benefits
If you are based in Cambridge, MA; Waltham, MA; Rockville, MD; or San Francisco, CA, the annual base salary for new hires in this position ranges from $188,100 to $313,500. The US salary ranges take into account work location within the US market, the candidate’s skills, experience, education level and the market rate for the role. The position offers an annual bonus and eligibility to participate in a share‑based long‑term incentive program. Available benefits include health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and paid caregiver/parental and medical leave.
Adjustments & Accommodations
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities, contact us at UKRecruitment.Adjustments@gsk.com.
Equal Opportunity Employer
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.
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