GSK
VP, Clinical Pharmacology & Pharmacometrics, Systems and Tools
GSK, Waltham, Massachusetts, United States, 02254
Overview
VP, Head, Clinical Pharmacology & Pharmacometrics Systems & Tools — lead a team of scientists in clinical pharmacology, pharmacokinetics, pharmacodynamics, and modelling and simulation. The team enables data-driven decisions across target to patient, supporting Infectious Diseases, ViiV and Global Health portfolios and assets in life cycle management. Location availability includes USA (PA: Upper Providence; MA: Waltham), and UK (Stevenage, London – New Oxford Street). This is an on-site role requiring 2 to 3 days per week on-site in the specified locations. Posted Date:
Aug 11 2025.
Closing Date:
Monday, September 8th, 2025 5:00pm EST. Note: This description is for the VP, Head of Clinical Pharmacology & Pharmacometrics Systems & Tools. Responsibilities include establishing standardized, reproducible, quality-assured practices across R&D and applying systems engineering principles to PK/PD modelling to support drug development and regulatory submissions. Key Responsibilities
Accountable for high-quality, timely delivery of all Clinical Pharmacology support to the portfolio. Influence alignment of clinical pharmacology with peer groups across TA CPMS units; manage relationships with Regulatory (internal), Biostatistics, DMPK, Clinical, Imaging, Clinical Biomarker, and Research Units. Oversee operational resource management and global resource oversight. Support modelling practices, processes, and procedures to support drug development programs. Ensure tools and standards enable PK/PD data analysis to inform dosing regimens and variability across patient populations. Develop and validate pharmacometric models in a standardized, traceable manner using internal or external tools. Collaborate with Rus (research units), clinical, regulatory, and statistical teams to integrate pharmacometric insights into trial design and regulatory submissions. Identify and resolve technical issues within systems/tools; drive continuous improvement and standardization. Generate reports and presentations communicating modelling results to stakeholders. Guide and mentor junior pharmacometricians or engineers. Stay current with advancements in pharmacometrics and relevant regulations. Basic Qualifications
PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacy, Pharmacology, Mathematics, Statistics, Engineering, or Bioinformatics. 15+ years' experience in clinical pharmacology, pharmacometrics/modeling and simulation in the global pharmaceutical industry with a focus on drug development and regulatory submissions. Experience in population PK/PD modelling, exposure–response analysis, and disease progression modelling. Experience with modelling and simulation software such as NONMEM, R, Monolix, Phoenix NLME, SAS, Python. Direct line management experience. Background in statistical methodologies relevant to pharmacometric analysis. Experience with regulations and guidelines for pharmacometric analyses (FDA, EMA, ICH). Preferred Qualifications
Excellent communication, collaboration, and interpersonal skills. Ability to work with cross-functional teams and influence stakeholders at all levels. QSP experience. Ability to analyze complex data and develop effective solutions. Experience with systems engineering principles or related technical areas. For US applicants, visit the GSK US Benefits Summary for information on the benefits program. Why GSK?
We unite science, technology and talent to get ahead of disease together, focusing on infectious diseases, HIV, respiratory/immunology and oncology. GSK is an Equal Opportunity Employer and provides accommodations on request in accordance with applicable law. If you require accommodation to apply, contact GSK Service Centre at 1-877-694-7547 (US) or +1 801 567 5155 (outside US). Important notice to Employment agencies: GSK does not accept referrals from employment businesses/agencies without prior written authorization. Seniority level
Not Applicable Employment type
Full-time Job function
Other Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GSK. Note: This posting is no longer accepting applications; the role is likely closed as of the closing date.
#J-18808-Ljbffr
VP, Head, Clinical Pharmacology & Pharmacometrics Systems & Tools — lead a team of scientists in clinical pharmacology, pharmacokinetics, pharmacodynamics, and modelling and simulation. The team enables data-driven decisions across target to patient, supporting Infectious Diseases, ViiV and Global Health portfolios and assets in life cycle management. Location availability includes USA (PA: Upper Providence; MA: Waltham), and UK (Stevenage, London – New Oxford Street). This is an on-site role requiring 2 to 3 days per week on-site in the specified locations. Posted Date:
Aug 11 2025.
Closing Date:
Monday, September 8th, 2025 5:00pm EST. Note: This description is for the VP, Head of Clinical Pharmacology & Pharmacometrics Systems & Tools. Responsibilities include establishing standardized, reproducible, quality-assured practices across R&D and applying systems engineering principles to PK/PD modelling to support drug development and regulatory submissions. Key Responsibilities
Accountable for high-quality, timely delivery of all Clinical Pharmacology support to the portfolio. Influence alignment of clinical pharmacology with peer groups across TA CPMS units; manage relationships with Regulatory (internal), Biostatistics, DMPK, Clinical, Imaging, Clinical Biomarker, and Research Units. Oversee operational resource management and global resource oversight. Support modelling practices, processes, and procedures to support drug development programs. Ensure tools and standards enable PK/PD data analysis to inform dosing regimens and variability across patient populations. Develop and validate pharmacometric models in a standardized, traceable manner using internal or external tools. Collaborate with Rus (research units), clinical, regulatory, and statistical teams to integrate pharmacometric insights into trial design and regulatory submissions. Identify and resolve technical issues within systems/tools; drive continuous improvement and standardization. Generate reports and presentations communicating modelling results to stakeholders. Guide and mentor junior pharmacometricians or engineers. Stay current with advancements in pharmacometrics and relevant regulations. Basic Qualifications
PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacy, Pharmacology, Mathematics, Statistics, Engineering, or Bioinformatics. 15+ years' experience in clinical pharmacology, pharmacometrics/modeling and simulation in the global pharmaceutical industry with a focus on drug development and regulatory submissions. Experience in population PK/PD modelling, exposure–response analysis, and disease progression modelling. Experience with modelling and simulation software such as NONMEM, R, Monolix, Phoenix NLME, SAS, Python. Direct line management experience. Background in statistical methodologies relevant to pharmacometric analysis. Experience with regulations and guidelines for pharmacometric analyses (FDA, EMA, ICH). Preferred Qualifications
Excellent communication, collaboration, and interpersonal skills. Ability to work with cross-functional teams and influence stakeholders at all levels. QSP experience. Ability to analyze complex data and develop effective solutions. Experience with systems engineering principles or related technical areas. For US applicants, visit the GSK US Benefits Summary for information on the benefits program. Why GSK?
We unite science, technology and talent to get ahead of disease together, focusing on infectious diseases, HIV, respiratory/immunology and oncology. GSK is an Equal Opportunity Employer and provides accommodations on request in accordance with applicable law. If you require accommodation to apply, contact GSK Service Centre at 1-877-694-7547 (US) or +1 801 567 5155 (outside US). Important notice to Employment agencies: GSK does not accept referrals from employment businesses/agencies without prior written authorization. Seniority level
Not Applicable Employment type
Full-time Job function
Other Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at GSK. Note: This posting is no longer accepting applications; the role is likely closed as of the closing date.
#J-18808-Ljbffr