Executive Director, Oncology Translational Medicine, Clinical Pharmacology Modeling and Simulation

Executive Director, Oncology Clinical Pharmacology Modeling and Simulation

We have an exciting opportunity at GSK for a highly motivated and experienced Executive Director to join our team supporting the Oncology Clinical Pharmacology Modelling and Simulation (CPMS) department within Oncology Translational Medicine. This role focuses on delivering CPMS excellence to research and development programs, helping to accelerate the development of innovative oncology therapies by ensuring they reach the right patients, at the right dose, and at the right time.

Job Purpose

The Executive Director, Clinical pharmacology is responsible for strategic contributions to both drug discovery and development projects. Working in collaboration with colleagues in Research, Clinical < medical, DMPK and Clinical Pharmacology to translate and bridge findings that clinical pharmacology can implement into clinical trials. The incumbent will act as a subject matter expert, working closely with the VP, Head of Oncology Clinical Pharmacology, Modeling and Simulation and the Oncology Translational Medicine leadership to provide scientific leadership in trial design, data interpretation, and aid in global harmonization of pre-clinical execution and reporting. He/she will collaborate with clinical pharmacologists and clinical and other professionals in designing program strategies, execution and communication to achieve team, department, and corporate goals.

This position requires an on-site office presence for 2-3 days per week.

Key Responsibilities:

This role will provide YOU the opportunity to contribute and lead key activities to progress YOUR career, including:

• provide advanced technical, therapeutic, and product development support for programs with a focus on the Oncology portfolio.
• provide managerial support to CPMS Managers and Directors. Individuals will be accountable to provide individually, or via their direct reports, optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), Clinical Pharmacology and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds.
• bridging to clinical pharmacology, and modeling/simulation in support of development programs
• collaborate to identify and propose initial design for clinical pharmacology studies (e.g., rBA/BE, DDI, special population, human ADME, and TQT etc.) needed to support clinical development plans, risk assessment, and collaborate with research and development teams
• input on development of efficient and effective modeling and simulation strategies, including population PK, exposure-response analysis, and physiologically based PK (PBPK) to support clinical trial design, justification of dosing regimen, and provide supportive evidence of efficacy and safety for regulatory submissions
• lead and/or contribute to the authoring of relevant sections/modules of regulatory dossier (including INDs, IBs, briefing packages, or other regulatory dossier)
• participate in meetings with regulatory authorities, as needed
• implement best practices, trends, learnings, etc from internal and external sources to further CPMS contribution to R&D pipeline
• influence, define and execute a coordinated scientific and/or technical strategy (18-24 months planning horizon). Demonstrated ability to co-ordinate outputs from several expertise areas to determine strategy.
• Identify and develop talent, providing appropriate coaching to ensure future leadership/succession plans for the CPMS organization.
• advise team in the analysis of data, including internally or externally contracted PK/PD data analysis and advanced modeling and simulation, from nonclinical studies
• develop relationships with external parties and consortia (and stay current on industry trends and practices.

• other duties as assigned.

Why you?

Basic Qualifications:

These may include but are not limited to:

• PhD biological/pharmaceutical sciences or related discipline with 15+ years of experience in a biotech/life science, pharmaceutical or related industry (an equivalent combination of experience and education may be considered).
• Extensive experience in drug development functions (e.g., Nonclinical and Clinical) is required.
• A minimum of 15 years of experience managing matrix team, external service providers (worldwide), and consultants is required.
• A minimum of 5 years of experience in managing talent/direct reports
• Hands-on experience with clinical PK and PK/PD data analysis; and expertise with advanced modeling and simulation (e.g., Population PK, PBPK).
• Prior experience of translational research and clinical pharmacology in ADCs, TCEs, small molecules and antibodies.
• Excellent command of applicable GxPs and standard processes.
• Demonstration of cross-functional understanding related to drug development.

Preferred Qualifications:

• Ability to learn new areas of biological sciences and build on solid foundation of quantitative skills to develop mechanistically-sound PK-PD models.
• Understanding of PK-PD principles and commonly applied models.
• Ability to translate, condense, summarize outcomes of modeling and simulation analyses into information that can be understood and invested by project teams.
• Ability to keep up-to-date with and propose the implementation of scientific and technological developments in the area of mechanistic PK-PD.
• Knowledge of or ability to quickly learn the mechanisms, endpoints, disease understanding and treatment approaches in Oncology and other relevant therapy areas.
• Good listener and ability to effectively interact with colleagues with a variety of backgrounds.
• Self-directed, independent, and highly motivated researcher who excels in a collaborative, multi-disciplinary team environment.
• Ability to build effective collaboration while taking personal accountability for delivery of quantitative clinical pharmacology results.
• Ability to effectively multi-task and deliver results on time.
• Good judge of risks and excellent problem-solving ability to analyze options and manage outcomes.
• Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved across disciplines.
• Inter-personal and talent growth skills.
• Excellent writing skills and familiar with ICH/FDA/EMA guidance/guidelines
• Excellent interpersonal skills with strong oral/written communication and presentation skills.
• Well versed with the latest trends in the drug development industry and relevant technology solutions.