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)