Associate Director, Clinical Pharmacology
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Job Description
Associate Director leading clinical pharmacology strategy in a pharmaceutical company developing therapies for endocrine diseases. Responsible for designing and reporting Phase 1 clinical pharmacology studies.
Responsibilities:
- responsible for developing clinical pharmacology strategy suitable for target product profile (TPP) and clinical development plan (CDP)
- leading the design, execution, interpretation, and reporting of Phase 1 clinical pharmacology studies
- serve as clinical pharmacology lead on studies and project teams
- support projects at various stages of development thereby allowing the selected candidate to play an active role in drug discovery and development efforts
- contribute to 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 therapeutics
- collaborate with DMPK and clinical research teams to define biopharmaceutics and clinical pharmacology studies needed to support an NDA and drug label
- determine scope, design, plan, and analyze phase 1-4 pharmacokinetic and pharmacodynamics studies
- champion model-informed drug development (MIDD)
- plan, prepare, and review drug development plans and regulatory filings
- provide clinical pharmacology expertise to the project team and closely collaborate with Clinical Operations, Clinical Research, Biometrics, and Bioanalysis
- contribute to the design Phase 1 clinical pharmacology studies (eg, drug-drug interactions, relative bioavailability/bioequivalence, special populations, etc.)
- participate in the selection of Phase 1 CROs for clinical pharmacology studies
- be accountable and responsible for the analysis and interpretation of PK and PK/PD data
- participate in preparation of clinical study protocol and report
- prepare clinical pharmacology section of the regulatory documents (IND, IMPD, IB, NDA CTD, etc.)
- respond to regulatory requests for information (RFIs)
- serve as the primary Clinical Pharmacology Lead
Requirements:
- Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, Engineering or related field with a strong understanding of clinical pharmacology principles
- 8+ years of significant industry experience in conduct and/or oversight of clinical pharmacology studies and data analysis
- Familiarity 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 projects
- Demonstrated ability to independently develop clinical pharmacology strategy and design studies to characterize PK and PK/PD relationships of clinical development compounds
- Expertise/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 studies
- Experiences in preparation of INDs, CTAs, NDAs, and MAAs, as well as successful results from the filings
- Experience in working in a cross functional team/matrix environment
- Competent in the use of PK and PK/PD software tools such as Phoenix
- Strong written, presentation, and verbal communication skills
- Demonstrated application of MIDD for development strategy and/or decision-making.
Benefits:
- health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- winter company shutdown
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
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