Senior Director, Vaccines Program Leader

Highly Competitive Salary
  1. Permanent
  2. Senior/Director & VP, Immunology, Pharmacology
  3. United States
Cambridge, USA
Posting date: 25 Mar 2021
SC.MR.36538

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.

Job Responsibilities:

  • 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 m.robinson@proclinical.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.

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