Senior Director, Clinical Pharmacology

Job Description: Develop clinical pharmacology strategy and related clinical development plan consistent with the target product profile, program goals, and the US/international regulatory guidance/guideline of small molecule therapeuticsCollaborate with DMPK, clinical research, and CMC teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug labelDetermine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studiesprovide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis.Participate in the selection of Phase 1 CROs for clinical pharmacology studiesAccountable and responsible for the analysis and interpretation of PK and PK/PD dataParticipate in preparation of clinical study protocol and reportPlan, prepare, and review clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.)Serve as the primary Clinical Pharmacology Lead and effectively participate in cross functional teams to insure integration of modern clinical pharmacology principles into project plans and study designRepresent clinical pharmacology at regulatory meetings and advisory hearings with global health authorities as a subject matter expertFocus on both immediate/short-term ( Lead, direct, manage, develop, coach/mentor, and evaluate direct reports, contributing to budget and headcount planning.Requirements: Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field with a strong understanding of clinical pharmacology principles10+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysisminimum of 10 years of experience in a supervisory role13 years of overall professional experience is requiredFamiliarity with all stages of clinical drug development, including prior experience in the preparation of components of the Clinical Pharmacology sections of Regulatory submissions for IND- and NDA-stage projectsDemonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compoundsExpertise/experience in multiple clinical pharmacology areas is preferred - FIH and/or Ph II/III dose selection, pediatric dose selection, drug-drug interactions, enzymology of drug metabolism, formulation bridging, bioequivalence, food-effect, exposure-QTc assessments, special population, and radiolabeled mass balance studiesExtensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filingsExperience in working in a cross functional team/matrix environment with strong vendor management skillsCompetent in the use of PK and PK/PD Modeling software tools such as PhoenixStrong written, presentation, and verbal communication skillsCritical thinker with strong problem-solving skillsAbility to influence business leaders at all levels.Benefits: discretionary annual target bonusstock optionsESPP401k matchtop-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance20 days of PTO10 paid holidayswinter company shutdown