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

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.
• 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
• 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?

Requirements

• 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.
• 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 motivate

Additional Information

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

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