GSK · 19 hours ago
Director Clinical Pharmacology MIDD Lead
Collegeville, PA
Full-time
Hybrid
Director/Executive
$181K/yr - $301K/yrGSK is a global biopharma company focused on advancing health through innovative medicines and vaccines. They are seeking a Director Clinical Pharmacology MIDD Lead who will be responsible for leading the development and implementation of Model-Informed Drug Development (MIDD) evidence strategies, integrating advanced modeling and simulation approaches to optimize drug development decisions.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Design & Execute MIDD Strategies: Drive optimal use of MIDD approaches, associated data plans and model evaluation strategies, to inform disease-, program-, and business-level decisions. Develop and implement robust evidence strategies within RIIRU, advancing MIDD Evidence frameworks and documentation standards to de-risk and accelerate programs, optimizing internal and regulatory strategies to deliver transformative therapies
Technical Expertise: Act as a subject matter expert for modeling and simulation (M&S) for a (sub)-therapeutic area serving as a contributor and technical coach. Lead development of the more technically challenging M&S plans, analyses, and reports. Contribute to regulatory interactions involving quantitative evidence, ensuring clear communication of modeling assumptions, rigor in alignment with the impact on decision-making
Optimize & Innovate: Promote effective use of current M&S methodologies (e.g., MBMA, disease progression modeling) and integrate with emerging technologies (AI/ML, SciML). Develop good practices, training, and wider adoption strategies
Shape Future Methods: Collaborate with global CPMS, academic partners, and external experts to develop scalable methodologies aligned with RIIRU needs
Cross-Functional Partnerships: Build strong networks across AI/ML, CPMS, QSP, biomarkers, digital, imaging, biostatistics, clinical, and real-world data teams to embed advanced modeling into decision-making frameworks
External Engagement: Enhance external profile through publications, conferences, and contributions to scientific and regulatory communities in MIDD, pharmacometrics, QSP, and AI/ML integration
Qualification
Required
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
Preferred
A strong knowledge of and experience applying MIDD in RIIRU-relevant disease areas with knowledge of the Hepatology disease area an additional advantage
Hands-on use of AI/ML and application to MIDD M&S methods
Hands-on PBPK and/or QSP skills
Benefits
Annual bonus
Eligibility to participate in our share based long term incentive program which is dependent on the level of the role
Health care and other insurance benefits (for employee and family)
Retirement benefits
Paid holidays
Vacation
Paid caregiver/parental and medical leave
Company
GSK
We are uniting science, technology and talent to get ahead of disease together. Our community guidelines: https://gsk.to/socialmedia
Founded in 1929
10001+ employees
H1B Sponsorship
GSK has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (56)
2023 (54)
2022 (53)
2021 (54)
2020 (72)
Funding
Current Stage
Public CompanyTotal Funding
$25.51MKey Investors
CARB-X
2021-03-02Grant· $18M
2020-09-23Grant· $7.51M
1978-01-13IPO
Leadership Team
Julie Brown
CFO
Mike Elmore
SVP & Chief Information Security Officer, GSK
Recent News
South China Morning Post
2026-01-08
2026-01-07
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