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

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

Qualifications:

• 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
• Previous experience in gastroenterology, dermatology and/or inflammatory indications preferred
• Ability to communicate effectively and with confidence, and work in a matrix environment

The range of starting base pay for this role is 167K-229K. Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, stock purchase plan, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts. 

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