Director Clinical Pharmacology Oncology
Site Name: USA - Massachusetts - Waltham Posted Date: Jul 28 2021 Job purpose: The Clinical Pharmacology Modelling and Simulation (CPMS) Team is recruiting a Director-level Clinical Pharmacologist with strong clinical pharmacology and pharmaco-metric skills. CPMS is a science-driven group using quantitative clinical pharmacology approaches, as part of the model-informed drug discovery and development (MID3) paradigm, to evolve understanding of compound behavior and optimize dose across the development continuum, delivering a competitive label. This opportunity enables YOU to bring clinical pharmacology and modelling & simulation excellence to development programs; and to work on biologics, novel modalities, small molecules, and cell therapy in the oncology area. Your responsibilities : CPMS responsibilities cover the life cycle of drug development, commencing engagement post-lead optimization with accountability occurring from approximately 6 months prior to FTIH through to end of life cycle management. Provide optimal application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development, risk management, and registration of compounds. Guide the development of mathematical models to understand a disease, its progression, and drug pharmacodynamics and pharmacokinetics; ensure the conduct of meta-analyses as appropriate to generate knowledge through data re-use; conduct simulations to assess trial design performance Play a central role in predicting human dose range, by the characterizing dose-response relationship and justifying dose recommendations for special populations Present the CPMS strategy and be able to discuss outcome of model-based approaches via interactions with governance boards and regulatory agencies. Sere of studies as the lead for clinical pharmacologist who sets up the design of the relevant study activities in collaboration with other functions, as needed 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) through external collaboration, journal publication and conference presentation Contribute, as a member of a multi-disciplinary team, to the design of an efficient clinical development programs and robust registration packages Design and interpret clinical pharmacology studies to evaluate potential effects of intrinsic and extrinsic factors on pharmacokinetics and pharmacodynamics Write sections of drug development and registration documents such as clinical trial protocols and reports, clinical investigator brochures and regulatory submission packages Innovate through working effectively with colleagues in the department and other matrix team Why you? Basic Qualifications: We are looking for professionals with the following required skills to achieve our goals : Advanced training with a degree such as PhD, PharmD and MD to enable a successful career in quantitative clinical pharmacology in pharmaceutical research and development Proven experience in clinical pharmacology and its utility in drug development, including pharmacokinetics, pharmaco-metric approaches, and model-informed drug discovery & development Previous experience in working as a Quantitative Clinical Pharmacologist or equivalent Demonstrated aptitude in working with at least one of the following pharmaco-metric tools i.e. NONMEM, Monolix, WINNONLIN and R. Preferred Qualifications: The following characteristics are assets : Ability to articulate and advocate for the use of modeling and simulation approaches to address drug development issues and questions Drive and learning agility to build knowledge on a drug-disease system, symptom progression, standard of care, and trial design Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results Ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks Knowledge of or ability to quickly learn the mechanism, endpoints, progression and treatments of diseases in oncology. *LI-GSK Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk, governance and control, managing ambiguity and paradox. Managing individual performance. Creating a performance culture and driving results, prioritization, execution, delivering performance. Setting strategic direction and leading on-going organizational transformation. Building a resilient organization. Building strong relationships and collaboration in service of common goals, engaging the organization and building trusted external networks for mutual benefit. Managing P&L and capital allocation. If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). 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