Job Summary
A biotech research and development company has a current position open for a Remote CMC Product Strategy Team Lead Director.
Must be able to:
- Lead cross-functional Product Strategy team in developing and implementing CMC strategies
- Ensure CMC teams deliver data and supply to enable FIH, Pivotal and Phase 4 Clinical studies
- Facilitate delivery of CMC sections of regulatory filings and ensures any RTQs are addressed in time to meet Program milestones
Applicants must meet the following qualifications:
- 10+ years of experience in the pharmaceutical industry with prior experience leading cross functional teams
- BS or MS in Biotechnology, Chemical Engineering, Biology, or Chemistry; additional/postgraduate qualifications
- Strong leadership, negotiation, interpersonal, communication, and meeting facilitation skills
- Strong knowledge of commercialization
- Proven track record in a fast-paced, challenging, and complex matrixed team environment
- Demonstrated competency and hands-on experience with typical CMC activities
