GSK

Director, Clinical Pharmacology MIDD Lead

GSK

full-time

Posted on:

Location Type: Hybrid

Location: Waltham • Massachusetts, North Carolina • 🇺🇸 United States

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Salary

💰 $180,675 - $301,125 per year

Job Level

Senior

About the role

  • 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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
modelling and simulationpharmacometricsbiostatisticsdata sciencepopulation PK/PDexposure-responseMBMAdisease progression modelingclinical trial designregulatory strategy
Soft skills
leadershipcollaborationcommunicationaccountabilityjudgmentadaptabilityprioritization
Certifications
PhDPharmD