Senior Director, Clinical Pharmacology
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Job Description
Senior Director of Clinical Pharmacology developing clinical strategies for small molecule therapeutics at a clinical-stage pharmaceutical company. Leading key projects to advance treatments for rare endocrine disorders and related cancers.
Responsibilities:
- Develop clinical pharmacology strategy and related clinical development plan
- Collaborate with DMPK, clinical research, and CMC teams to define studies needed to support an NDA and drug label
- Determine scope, design, plan, and analyze phase 1-4 studies
- Provide clinical pharmacology expertise to project teams
- Contribute to the design of Phase 1 clinical pharmacology studies
- Participate in the selection of Phase 1 CROs for studies
- Accountable for the analysis and interpretation of PK and PK/PD data
- Participate in preparation of clinical study protocol and report
- Plan, prepare, and review clinical pharmacology section of regulatory documents
- Serve as the primary Clinical Pharmacology Lead in cross functional teams
- Represent clinical pharmacology at regulatory meetings
Requirements:
- Pharm. D./Ph.D. or MS in Pharmacokinetics, Pharmaceutical Sciences, Pharmacology, Chemistry, Biochemistry, or related field
- 10+ years of significant industry experience in conduct and/or oversight of clinical pharmacology function, studies, and data analysis
- Minimum of 10 years of experience in a supervisory role
- 13 years of overall professional experience is required
- Familiarity with all stages of clinical drug development
- Demonstrated ability to independently develop clinical pharmacology strategy and design studies
- Expertise/experience in multiple clinical pharmacology areas is preferred
- Extensive experience in preparation of INDs, CTAs, NDAs, and MAAs as well as successful results from the filings
- Competent in the use of PK and PK/PD Modeling software tools such as Phoenix
- Strong written, presentation, and verbal communication skills
- Critical thinker with strong problem-solving skills
- Ability to influence business leaders at all levels.
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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