Associate Director for Contracts providing senior - level leadership in negotiating complex research agreements. Overseeing compliance and operational procedures in grants and contracts within Rice University.
About the role
- Director Clinical Pharmacology MIDD Lead at GSK responsible for overseeing modeling and simulation in drug development decision-making. Collaborating with scientific experts to optimize drug development strategies.
Responsibilities
- The MIDD Lead is a scientific and strategic leader who applies modelling and simulation to inform drug development decisions.
- Responsible for leading the development and implementation of MIDD evidence strategies.
- Oversees integration and leads on the delivery of advanced modelling and simulation approaches.
- Incorporates disease-level data and novel digital and imaging endpoints to inform asset and mechanism-level decision-making.
- Integrates advanced pharmacometrics approaches, alongside systems pharmacology, biostatistics, and data science to optimize dosing, clinical trial design, regulatory strategy, and go/no-go decisions.
- Supports optimization and promotion of the effective use of established M&S methodologies (including MBMA and disease progression modelling) and the integration of emerging technologies (including AI/ML and SciML).
- Advocates for and advises on optimizing regulatory MIDD strategies to accelerate the delivery of transformative therapies to patients.
- Requires close partnership with AI/ML lead & experts within the MIDD team, Clinical Pharmacology Modelling & Simulation (CPMS), Quantitative Systems Pharmacology (QSP), digital, imaging, and biomarker teams within CPQM, as well multiple functions (e.g., Biostatistics, Clinical/Medical, Translation Sciences, Epidemiology) across RIIRU and GSK.
Requirements
- Advanced degree (PhD or PharmD and Postdoctoral experience preferred) in pharmacometrics, Clinical pharmacology, Physiological Pharmacokinetic and Pharmacodynamic based modelling or related quantitative disciplines QSP
- A deep understanding and examples of successful application of various M&S methods and software used in MIDD (e.g., population PK/PD, exposure-response, MBMA and disease progression modeling) and demonstration of their and their effective use in clinical development and regulatory decision making.
- An advanced understanding of relevant regulatory and ICH guidelines across major markets related to the design of clinical studies and drug development strategy with particular emphasis on the role of MIDD.
- Ability to quickly attain the therapeutic or sub-therapeutic area literacy sufficient to implement and communicate the MIDD strategy to clinical experts
- Demonstrated aptitude for productive collaboration in a multi-discipline team, using effective communication and taking personal accountability for timely delivery of results
- Clear evidence of ability to make sound judgement in complex situations and adapt to changing business needs by prioritizing multiple tasks
Benefits
- health care and other insurance benefits (for employee and family)
- retirement benefits
- paid holidays
- vacation
- paid caregiver/parental and medical leave
- annual bonus
- eligibility to participate in our share based long term incentive program
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