# Director, CPMS Oncology

**Company**: GSK
**Location**: Pennsylvania - Upper Providence
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $188,100 to $313,500
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://gsk.wd5.myworkdayjobs.com/en-US/GSKCareers/job/USA---Pennsylvania---Upper-Providence/Director--Oncology-Clinical-Pharmacology-Modeling---Simulation_450627?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
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## Description

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.

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.

**Key Responsibilities:**

- Contribute to the design of efficient clinical development programs and robust registration packages as a member of a multi-disciplinary team.

- 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.

- 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.

- 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.

**Basic Qualifications:**

- Advanced training with a PhD or MD in Pharmaceutical Sciences, (Bio)Engineering, Statistics, Medicine, or related field.

- 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.

**Preferred Qualifications:**

- Oncology drug development experience.

- Solid experience with advanced pharmacometric approaches.

- Experience in designing, analyzing, and reporting clinical studies.

- Familiarity with M&S contributions to regulatory interaction and submission documents.

**Benefits:**

- Health care and other insurance benefits (for employee and family).

- Retirement benefits.

- Paid holidays.

- Vacation.

- Paid caregiver/parental and medical leave.

**Salary:**

- $188,100 to $313,500 per year (for US locations)

## Skills

### Required
- Drug Design
- Drug Development
- Pharmaceutical Sciences
- Pharmacodynamics
- Pharmacokinetics
- Pharmacology
- Pharmacometrics

### Nice to have
- Oncology drug development
- Advanced pharmacometric approaches
- Model-based meta-analysis
- Adaptive dosing simulations
- Mechanistic PKPD modeling

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