Project Director coordinating major cross - functional Insurance projects and leading delivery initiatives at Manulife. Collaborating with teams to ensure successful market launch and project outcomes
MS
Hybrid Director, Infectious Diseases and Vaccines, Quantitative Pharmacology, Pharmacometrics
Posted 10 hours ago
About the role
- Director role in Quantitative Pharmacology applying quantitative approaches for drug development in infectious diseases and vaccines. Leading cross-functional teams and developing regulatory strategies with minimal supervision.
Responsibilities
- Apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics
- Inform dose selection and go/no-go decisions
- Shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications
- Lead QP2 efforts on drug development programs and author strategic documents
- Serve as an expert representative for QP2 on teams developing infectious disease or vaccine assets
- Mentor and/or supervise junior colleagues to develop capabilities in drug development
Requirements
- a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree with at least nine years of experience where 'experience' means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia)
- Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
- Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar)
- Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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