Senior Director, Vaccines Program Leader
We are seeing a Senior Director, Vaccines Program Leader to join an exciting biotech in Cambridge MA developing mRNA vaccines against infectious diseases. The Program Leader will define asset strategy and lead a cross-functional team across clinical operations, regulatory affairs, bioassays, CMC, non-clinical, and medical to deliver against the program strategy through Phase 3, BLA submission and life cycle management.
- Lead the cross-functional teams for mRNA vaccine programs;
- Represent the program status, scenarios, and trade-offs for vaccine assets with senior leadership, and internal and external stakeholders
- Align on a program direction in coordination with senior functional leaders
- Support development of regulatory documents and HA interactions up to and including BLA submission and VRBPAC
- Engage external stakeholders including KOLs and key PIs; engage advisory boards in order to develop an effective program strategy
- Accountable for the integrated development plan for the vaccine programs
- Develop a program budget in coordination with the program manager, finance and functional representatives; identify trade-offs
Skills and Requirements:
- BS/MS degree in a scientific field with 15+ years of experience or Ph.D or MD with 10-12 years of experience in a biotechnology or pharmaceutical setting
- Experience in vaccine development including the transition of novel candidates from discovery through licensure
- Proven track record of successful cross functional program leadership or management supporting early- and late-stage programs
- Strong ability to lead cross-functional teams; engage senior leadership, health authorities, and KOLs
- Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility
- Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
- Strong written and oral communication skills as well as demonstrated organizational aptitude
If you are having difficulty in applying or if you have any questions, please contact Max Robinson at (+1) 617-903-7746 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.