Senior Principal Scientist, Clinical Pharmacology

Bausch Health•Bridgewater, NJ

15d•Hybrid

About The Position

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact. The Senior Principal Scientist will lead the strategy, execution, and report of Clinical Pharmacology studies and Pharmacometrics deliverables for new development, post-marketing and maintenance of business projects Key technical responsibilities include the design and implementation of Clinical Pharmacology and/or Modeling & Simulation (M&S) strategies The individual will discuss Clinical Pharmacology and Pharmacometrics information with R&D staff, senior management, and consultants in order to convey key concepts and facilitate understanding of results and risks Integrate biology, pharmacology, toxicology, biomarker and clinical information to generate data and knowledge supporting the generation and implementation of translational models The individual will represent the clinical pharmacology function in cross-functional teams, and will provide support for the planning, implementation, and organization of project deliverables for internal decision making as well as for regulatory submissions

Requirements

Ph.D. in Pharmacokinetics/Pharmacodynamics, Clinical Pharmacology, Pharmacometrics, Pharmacology, or related field, or Pharm.D. with demonstrated clinical pharmacology and pharmacokinetic training and experience required. M.S. degrees with significant applicable experience will also be considered
PhD with minimum of 5 years of experience in clinical pharmacology and drug development in the pharmaceutical industry; Master’s degree with 10 years
Experience in applying clinical pharmacology, PK, PD, and pharmacometrics principles within drug development teams
Hands-on experience with non-compartmental and compartmental PK/PD analysis using Phoenix WinNonlin
Hands-on experience with one or more pharmacometrics analysis, e.g., PBPK modeling, population PK (popPK) modeling, exposure-response (E-R) analysis and pharmacometrics software platforms (e.g., Simcyp, GastroPlus, NONMEM, etc.)
Familiarity with LC/MS-based bioanalysis to support in vivo PK, toxicity, and PK/PD studies
Ability to communicate effectively and with confidence, and work in a matrix environment

Nice To Haves

Previous experience in gastroenterology, dermatology and/or inflammatory indications preferred

Responsibilities

Lead and support the design, conduct, interpretation and reporting of clinical pharmacology studies, including but not limited to PK, food effect, drug-drug interactions, TQT, and hepatic/renal impairment studies
Lead pharmacokinetics (PK) and/or pharmacodynamics (PD) aspects of study plans and integrate quantitative approaches into drug development projects
Conduct exploratory PK and pharmacometrics analyses such as Physiologically-based Pharmacokinetic (PBPK) or population PK (popPK) modeling to support therapeutic decisions, trial design, dosing strategies, and post-approval changes
Manage CRO/vendors to execute PK/PD and pharmacometrics deliverables for regulatory submissions
Represent the Clinical Pharmacology function in cross functional teams including Project Management, Clinical Operations, Clinical/Medical Affairs, Biostatistics, Regulatory Affairs and Medical Writing
Collaborate closely with the clinical project team to manage Phase I-III and post-marketing studies
Other responsibilities may include planning, writing, and reviewing relevant sections of clinical documents such as study protocols, analysis plans, reports, and regulatory documents (IBs, INDs, NDAs, etc.)
Maintain awareness of emerging literature and science in computational approaches and applications as well as relevant regulatory guidances