- Candidates must be local to San Diego, CA as this is a hybrid position.
Job Description:
Lead the development and execution of Clinical Pharmacology strategies for small molecule assets. Provide expertise in pharmacokinetics, dose optimization, pharmacometrics, and drug interaction assessment. Collaborate with cross-functional teams (Clinical, Research, Regulatory, Biometrics, etc.) and manage clinical pharmacology studies, data analysis, and regulatory filings.
Key Responsibilities:
- Develop clinical pharmacology and pharmacometrics strategies for small molecule drug candidates.
- Collaborate across disciplines to inform development decisions.
- Develop and execute clinical pharmacology and pharmacometrics strategies, including dose and schedule determination and dose optimization, to mitigate risks and support development of small molecule candidates from pre-IND and first-in-human testing through all phases of clinical development.
- Design, analyze, and report clinical pharmacology studies.
- Author and defend clinical pharmacology sections in regulatory submissions.
- Manage consultants and vendors to ensure quality and compliance.
- Author regulatory documents (IND’s, NDA’s, IB’s, etc.) and respond to regulatory inquiries related to PK/PD, and clinical pharmacology.
- Ensure that appropriate PK, PD and PK/PD data analyses (including population PK, PK/PD modeling and simulation) are conducted for each study/program while adhering to timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
- Analyze, interpret, summarize and present clinical pharmacology data to project teams, investigators and to senior management.
Requirements:
- Ph.D. in Pharmacokinetics, Pharmaceutical Sciences, or related field.
- 7+ years of relevant industry or post-doctoral experience.
- Strong communication skills; experience with regulatory filings preferred.
- Prior experience with NDA/BLA/MAA filings is desirable and prior experience in health authority and authoring responses required.
