Senior Vice President of Regulatory Sciences

Boston, Massachusetts. Posted 18 months ago

The role

The Senior Vice President of Regulatory Sciences will build and lead the Regulatory Sciences function from the ground up. This person will shape engagement with domestic and global health authorities and influence the pace of bringing therapies to patients.

What you will do

Build and lead the Regulatory Sciences function including Global Strategy, CMC, Operations and vendor management
Own and evolve regulatory strategy for clinical and preclinical programs
Serve as the company voice in regulatory interactions and lead health authority meetings
Partner with R&D, Clinical, and Technical Operations to ensure data packages and study designs are regulatory-ready
Drive innovation in regulatory science to support accelerated development paths
Contribute to portfolio prioritization, risk management, and long-range development planning
Mentor teams to think strategically about regulatory science

Required qualifications

Bachelor’s degree in a scientific discipline
20+ years of regulatory strategy experience in biotech or pharma
Experience building or scaling regulatory functions
Proven track record of success with INDs, BLAs, and global submissions
Deep experience in oncology
Hands-on experience serving as the primary point of contact with FDA/entities such as CBER and other global health authorities
Strong understanding of evolving global regulatory frameworks
Demonstrated startup mindset

Nice to have

Advanced degrees (Masters, PharmD, PhD)
Experience with expedited or accelerated designations such as RMAT, Breakthrough Therapy and/or Orphan Drug Designation
Experience in gene/cell therapies and/or rare disease

Benefits

Health
Dental
Life
Open PTO
Onsite lunch catering
Commuter support
Work/life flexibility and integration

About the company

Strand Therapeutics is a clinical-stage biotechnology company pioneering programmable mRNA therapeutics. Headquartered in Boston, MA, the company is advancing a pipeline with an initial focus on oncology and autoimmune disease.