Director, Oncology Clinical Pharmacology Modeling & Simulation

GlaxoSmithKline; Waltham (MA); Hybrid; USD 188,000 - 314,000; Full time

Benefits offered by this job

Hybrid work schedule

Annual bonus

Long-term incentive program

Health care & insurance benefits

Retirement benefits

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Clinical pharmacology

Modeling & simulation

Regulatory knowledge

Data analysis

Cross-functional collaboration

Education

PhD or MD in Pharmaceutical Sciences

PharmD or Master's with 4 years experience

Tools

NONMEM

Monolix

R

Job description

Job Purpose

We have an exciting opportunity at GSK for a highly motivated and experienced Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role combines both clinical pharmacology and modeling and simulation (M&S) accountabilities aiming to bring the value of model-informed drug development to our R&D portfolio, helping to inform and accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.

As a Director, CPMS Oncology, you will have the opportunity to work on small molecules, biologics, and/or antibody drug conjugates. Responsibilities generally commence post-candidate selection with accountability occurring from approximately 6 months prior to FTIH through to life cycle management. GSK provides a supportive environment for scientists who are aspiring to learn, contribute and lead to making an impact on development decisions through innovation, expertise, and influence.

Hybrid setting: office presence for 2-3 days per week.

Key responsibilities

• Contribute, as a member of a multi-disciplinary team, to the design of efficient clinical development programs and robust registration packages.
• Play a central role in predicting human dose range, characterizing exposure-response relationship and justifying dose recommendations for later studies and for special populations.
• Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics.
• Develop mathematical models to understand disease, its progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance.
• Present the CPMS strategy and discuss outcome of model-based approaches via interactions with project teams, governance boards and regulatory agencies.
• Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages.
• Provide a thorough understanding and ability to apply appropriate FDA and ICH guidelines in the design of clinical studies and drug development strategy.
• Advocate for the use of model-informed drug discovery and development (MID3) in teams and through external collaboration, journal publication and conference presentation.
• Innovate through working effectively with colleagues in the department and other matrix team members at study, indication and or program level, including development team leaders, statisticians, biologists, physicians and drug metabolism scientists.
• Learn and apply emerging modelling and simulation methodologies with a view to enhance clinical program efficiency and investment decision quality; collaborate with external field-leading teams for methodology application.

Basic Qualifications

• Advanced training with a PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine or related field. A PharmD or Master's degree in the same disciplines with an additional 4 years of relevant experience may be considered.
• 5+ years' experience leveraging clinical pharmacology and modeling in drug development.
• 5+ years' experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models.
• 5+ years of experience utilizing tools for quantitative clinical pharmacology such as NONMEM, Monolix, or R.
• Experience through previous roles in applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies.

Preferred Qualifications

• Oncology drug development experience.
• Solid experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, model-based meta-analysis, adaptive dosing simulations, and/or mechanistic PKPD modeling.
• Experience in designing, analyzing and reporting clinical studies, with a simulation- or modelling-based approach where appropriate.
• Familiarity with M&S contributions to regulatory interaction and submission documents
• Knowledge / ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology.
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.

• Sound judgement, analytical mindset and problem-solving skills.
• Ability to effectively multi-task and deliver results on time.

LI-GSK*

LI-Hybrid*

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 $188,100 to $313,500. 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.

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

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.

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