Director, Quantitative Clinical Pharmacologist
GSK
5 hours ago
Remote friendly (Waltham, MA)
United States
Clinical Research and Development
Quantitative Clinical Pharmacologist to support Infectious Disease and Oncology life cycle management programs.
Responsibilities:
- Contribute to the design of an efficient clinical development program, robust registration package, and support life cycle management of an asset.
- Apply Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles for efficient drug development, risk management, and registration.
- Predict human dose range; characterize exposure-response and justify dose recommendations for special populations.
- Develop mathematical models of disease progression and drug PK/PD; conduct meta-analyses for data re-use; run simulations to assess trial design performance.
- Present strategy and model-based outcomes with governance boards and regulatory agencies.
- Apply FDA and ICH guidelines to clinical study design and drug development strategy.
- Promote model-informed drug discovery and development (MID3) via collaboration, journal publication, and conference presentation.
- Design and interpret clinical pharmacology studies evaluating intrinsic/extrinsic effects on PK/PD.
- Use in silico PBPK approaches to reduce/review in vivo studies for DDI and special populations (as appropriate).
- Write sections of drug development and registration documents (protocols/reports, investigator brochures, regulatory submission packages).
- Learn and apply emerging modelling/simulation methodologies to enhance program efficiency and investment decision quality; collaborate with external teams.
Basic Qualifications:
- Advanced degree (PhD, PharmD, or MD).
- 5+ years in clinical pharmacokinetics, modelling & simulation, and model-informed drug development (designing, analyzing, reporting clinical studies).
- Pharmacometric experience for Oncology assets including ADCs.
- 2+ years in pharmacokinetic/pharmacodynamic principles and commonly applied models.
- 1+ year with quantitative clinical pharmacology tools (NONMEM, R, WINNONLIN, SIMCYP, SAS, MATLAB).
- 1+ year with regulatory submission documents (CTAs, INDs, NDAs, MAAs, BLAs).
- 1+ year applying FDA and ICH guidelines in clinical development plans/studies.
Preferred Qualifications:
- Expertise in modelling/simulation and/or vaccines/infectious disease.
- Knowledge of infectious disease mechanisms/endpoints/progression/treatments.
- Clear oral and written communication.
- Collaborative while accountable for delivery of quantitative clinical pharmacology results.
- Strong analytical mindset, sound judgement, problem-solving.
- Ability to multi-task and deliver on time.
Responsibilities:
- Contribute to the design of an efficient clinical development program, robust registration package, and support life cycle management of an asset.
- Apply Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles for efficient drug development, risk management, and registration.
- Predict human dose range; characterize exposure-response and justify dose recommendations for special populations.
- Develop mathematical models of disease progression and drug PK/PD; conduct meta-analyses for data re-use; run simulations to assess trial design performance.
- Present strategy and model-based outcomes with governance boards and regulatory agencies.
- Apply FDA and ICH guidelines to clinical study design and drug development strategy.
- Promote model-informed drug discovery and development (MID3) via collaboration, journal publication, and conference presentation.
- Design and interpret clinical pharmacology studies evaluating intrinsic/extrinsic effects on PK/PD.
- Use in silico PBPK approaches to reduce/review in vivo studies for DDI and special populations (as appropriate).
- Write sections of drug development and registration documents (protocols/reports, investigator brochures, regulatory submission packages).
- Learn and apply emerging modelling/simulation methodologies to enhance program efficiency and investment decision quality; collaborate with external teams.
Basic Qualifications:
- Advanced degree (PhD, PharmD, or MD).
- 5+ years in clinical pharmacokinetics, modelling & simulation, and model-informed drug development (designing, analyzing, reporting clinical studies).
- Pharmacometric experience for Oncology assets including ADCs.
- 2+ years in pharmacokinetic/pharmacodynamic principles and commonly applied models.
- 1+ year with quantitative clinical pharmacology tools (NONMEM, R, WINNONLIN, SIMCYP, SAS, MATLAB).
- 1+ year with regulatory submission documents (CTAs, INDs, NDAs, MAAs, BLAs).
- 1+ year applying FDA and ICH guidelines in clinical development plans/studies.
Preferred Qualifications:
- Expertise in modelling/simulation and/or vaccines/infectious disease.
- Knowledge of infectious disease mechanisms/endpoints/progression/treatments.
- Clear oral and written communication.
- Collaborative while accountable for delivery of quantitative clinical pharmacology results.
- Strong analytical mindset, sound judgement, problem-solving.
- Ability to multi-task and deliver on time.