Associate Director leading innovation initiatives for LGBTQ+ health at Penn. Overseeing project execution and sustainability strategies to improve health outcomes.
About the role
- Director of Clinical Pharmacology at BeOne developing strategies for oncology drug candidates. Leading hands-on analysis and regulatory interactions for clinical development and drug registration.
Responsibilities
- Develop and execute clinical pharmacology and pharmacometrics strategies to mitigate risks and support development of small molecule and/or biologics drug candidates
- Develop clinical pharmacology study designs and collaborate with CROs and Clinical Operations to write study protocols, amendments, and reports
- Conduct hands-on clinical PK and pharmacometric data analysis
- Analyze, interpret, summarize, and present data to internal project teams, senior management, and to global health authorities
- Present data and interpretations to health authorities to enable optimal clinical development and registration of novel drugs
- Author, review, and finalize relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions
Requirements
- A Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, Biomedical Engineering or related discipline
- At least eight years of industry and/or related post-doctoral experience is preferred
- Demonstrable scientific, clinical development and regulatory experience based on prior experience with NDA/BLA/MAA filings and/or publications is essential
- Familiarity with DMPK studies, bioanalytical methods are preferred
- Prior experience in oncology drug development is preferred
- Prior experience with Quantitative System Pharmacology (QSP) modeling, Bispecific antibody, AI ML in drug development, PBPK modeling is a significant plus
Benefits
- Medical
- Dental
- Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
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