Director, Oncology Clinical Pharmacology Modeling & Simulation

GSK • Waltham, PA

6d • Hybrid

About The Position

GSK is seeking a Director to support the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. The role combines clinical pharmacology and modeling and simulation responsibilities to apply model-informed drug development across the R&D portfolio and help develop oncology therapies for the right patients, at the right dose, and at the right time. Work may involve small molecules, biologics, and antibody drug conjugates. Responsibilities generally begin after candidate selection, with accountability starting approximately six months before first-time-in-human studies and continuing through lifecycle management. The position follows a hybrid schedule, with office attendance two to three days per week.

The Director contributes clinical pharmacology and quantitative expertise to multidisciplinary teams, informs development decisions, and advocates for model-informed drug discovery and development. The role includes collaboration with internal colleagues and external experts, and communication of strategies and results to project teams, governance boards, and regulatory agencies.

Requirements

• PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine, or a related field; a PharmD or master's degree in the same disciplines may be considered with an additional four years of relevant experience.
• At least five years of experience leveraging clinical pharmacology and modeling in drug development.
• At least five years of experience applying pharmacokinetic and pharmacodynamic principles and commonly applied pharmacometric models.
• At least five years of experience using quantitative clinical pharmacology tools such as NONMEM, Monolix, or R.
• Experience applying appropriate FDA and ICH guidelines in the design of clinical development plans and studies.

Nice To Haves

• Oncology drug development experience.
• Experience with advanced pharmacometric approaches such as tumor size kinetics and joint models, model-based meta-analysis, adaptive dosing simulations, or mechanistic PKPD modeling.
• Experience designing, analyzing, and reporting clinical studies using simulation- or modeling-based approaches where appropriate.
• Familiarity with modeling and simulation contributions to regulatory interactions and submission documents.
• Knowledge of, or ability to quickly learn, oncology disease mechanisms, endpoints, progression, and treatments.
• Ability to build effective collaborations while taking personal accountability for delivering quantitative clinical pharmacology results.
• Sound judgment, analytical mindset, and problem-solving skills.
• Ability to multitask effectively and deliver results on time.

Responsibilities

• Contribute to multidisciplinary teams designing efficient clinical development programs and robust registration packages.
• Predict human dose ranges, characterize exposure-response relationships, and justify dose recommendations for later studies and special populations.
• Design and interpret clinical pharmacology studies assessing intrinsic and extrinsic effects on pharmacokinetics and pharmacodynamics.
• Develop mathematical models of disease, disease progression, and drug pharmacodynamics and pharmacokinetics; conduct meta-analyses and simulations to assess trial design performance as appropriate.
• Present CPMS strategies and model-based outcomes to project teams, governance boards, and regulatory agencies.
• Write drug development and registration document sections, including clinical trial protocols and reports, clinical investigator brochures, and regulatory submission packages.
• Apply appropriate FDA and ICH guidelines to clinical study design and drug development strategy.
• Advocate for model-informed drug discovery and development through team work, external collaboration, journal publications, and conference presentations.
• Collaborate with departmental colleagues and matrix team members, including development team leaders, statisticians, biologists, physicians, and drug metabolism scientists.
• Learn and apply emerging modeling and simulation methodologies to improve clinical program efficiency and investment decision quality, including through collaboration with external teams.

Benefits

• Annual bonus.
• Eligibility to participate in a share-based long-term incentive program, dependent on role level.
• Health care and other insurance benefits for employees and family.
• Retirement benefits.
• Paid holidays.
• Vacation.
• Paid caregiver, parental, and medical leave.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree