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

GlaxoSmithKline; Philadelphia (Philadelphia County); Hybrid; USD 223,000 - 371,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Health benefits

Retirement benefits

Paid holidays

Parental leave

Job summary

GlaxoSmithKline seeks a Senior Director to lead Cardiovascular and Metabolic Disease Clinical Pharmacology Modeling and Simulation. The role guides end-to-end MIDD across drug development, from first-in-human studies to filing and lifecycle management, reporting to RIIRU.

The position emphasizes regulatory strategy, data-driven decision making and leadership of a high-impact team. The role sits within CPQM and collaborates with digital medicine, translational imaging, biology, data science and

Qualifications

• PhD, MD or PharmD required.
• 8+ years in clinical pharmacology, modelling/simulation and drug development.
• Experience with pharmacometrics applied to clinical questions.
• Experience working with senior stakeholders in cross-functional teams.
• Experience in Cardiovascular and Metabolic Diseases.

Responsibilities

• Design and execute MIDD and ClinPharm strategies to de-risk RIIRU programs.
• Coordinate CPMS activities across RIIRU assets with global priorities.
• Draft and review clinical pharmacology regulatory content for approvals.
• Build cross-functional partnerships with CPQM and related functions.
• Engage externally to raise GSK's profile in MIDD and AI/ML integration.

Skills

Clinical Pharmacology

Modeling & Simulation

Pharmacometrics

Regulatory Strategy

MIDD

QSP

Cross-functional leadership

Education

PhD, MD, or PharmD

Job description

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

For candidates seeking to be located at our Stevenage site, this role will temporarily be based at Stevenage. However, the Company plans to relocate its offices to Cambridge, UK. The location of this role will therefore subsequently change to Cambridge, UK in accordance with timelines to be set by the Company. The relocation is currently proposed to take effect by early 2029.

The Department of Clinical Pharmacology Modelling & Simulation in Respiratory and Inflammation (CPMS R&I) at GSK is recruiting for a Director-level Clinical Pharmacologist with strong Respiratory and Inflammation expertise.

This role sits within the newly established Clinical Pharmacology and Quantitative Medicine (CPQM) organisation, which aims to be a centre of excellence in ModelInformed Drug Development (MIDD) by integrating clinical pharmacology, digital medicine, translational imaging and mechanistic/systems modelling.

You will lead the endtoend application of MIDD across the drug development lifecycle - from firstinhuman studies through filing and lifecycle management - and provide clinical pharmacology strategy and evidencegeneration input. This is an opportunity to join a highly regarded, highimpact team with a strong publication track record, reporting directly to the Respiratory, Immunology & Inflammation Research Unit (RIIRU).

Main responsibilities and accountabilities include, but are not limited to:

• Design & Execute Model Informed and Clinical Pharmacology strategies

  Develop and implement robust MIDD & ClinPharm evidence strategies to de risk and accelerate RIIRU programs. Aim for faster development, optimal dosing and stronger regulatory positioning across respiratory, inflammation, neurodegeneration and emerging areas - and support business development opportunities.

• Coordinate & Optimize CPMS activities

  Coordinate CPMS activities across and above assets within RIIRU, ensuring consistency and alignment of global CPMS/CPQM priorities and senior leadership. 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.) to shape RIIRU portfolio and disease areas. Build and sustain strong working relationships inside and outside CPMS to maximise scientific and operational impact.

• Ensure robust ways of working and regulatory ready evidence

  Approve study designs, analyses, interpretation, reports and clinical pharmacology regulatory documents across RIIRU portfolio. 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. Capture and roll out lessons learned and trends to continuously improve CPMS contributions to the R&D pipeline.

• Build cross functional partnerships

  Maintain strong networks and share best practices across CPQM expertise (digital medicine, QSP, translational imaging), the CPMS community of practice. Establish build strong network key functions such as AI/ML, biomarkers, biostatistics, clinical operations, data science, computational biology and RWE to embed quantitative approaches into decision making.

• 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.

Why you?

Basic Qualifications:

• PhD, MD, or PharmD.
• 8+ years of industry experience in clinical pharmacology, modelling/simulation and drug development to solve practical problems in pharmaceutical industry.
• 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.

Preferred Qualifications:

• 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.
• Strong 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.
• Strong drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design.

LI-GSK*

LI-Hybrid*

Skills

Drug Design, Drug Development, Drug Discovery Process, Drug Discovery Research, Medication Safety, Molecular Modeling, Pharmaceutical Regulatory Compliance, Pharmaceutical Sciences, Pharmacodynamics, Pharmacokinetics, Pharmacology, Pharmacometrics, Pharmacovigilance, Study Design, Target Validation* 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 $222,750 to $371,250. The US salary ranges take into account a number of factors including work location within the US market, the candidate's skills, experience, education level and the market rate for the role. In addition, this position offers an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. 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. If salary ranges are not displayed in the job posting for a specific country, the relevant compensation will be discussed during the recruitment process.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at [e-mail].

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.