Senior Director – MIDD Lead

DirectorDirectorFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany SiteLinkedIn

Location

Pennsylvania

Posted

9 days ago

Salary

$202.5K - $337.5K / year

Seniority

Senior

Postgraduate Degree7 yrs expEnglish

Job Description

• Own end-to-end MIDD evidence strategies for a therapeutic or sub-therapeutic area, guiding data prioritisation, integration, quality assessment, and application of advanced modelling to drive scientific, program, and business decisions • Act as the MIDD technical authority, leading M&S plans, analyses, and reports, coaching internal and external analysts, and supporting regulatory interactions involving quantitative evidence • Lead the delivery of robust, transparent MIDD evidence to de-risk and accelerate programs, advising on optimized internal and regulatory MIDD strategies • Drive consistent use of established M&S methodologies (e.g., MBMA, disease progression modelling) and integrate emerging technologies (AI/ML, SciML) through standards, training, and best practices • Build strong internal and external networks across CPMS, QSP, AI/ML, digital, biomarkers, and academia to shape future methodologies and strengthen GSK’s scientific and regulatory presence

Job Requirements

  • PhD or PharmD in pharmacometrics, Clinical pharmacology, Physiological Pharmacokinetic and Pharmacodynamic based modelling or related quantitative disciplines QSP
  • Minimum of 7 years experience in quantitative clinical pharmacology / pharmacometrics in an industry environment
  • A strong 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

Benefits

  • health care and other insurance benefits (for employee and family)
  • retirement benefits
  • paid holidays
  • vacation
  • paid caregiver/parental and medical leave

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