Job Summary:
Strand is looking to build a team that understands the value of working at a start-up. Joining Strand now places you alongside the founding executive team and world-leading advisors. We are looking for people who have the enthusiasm and motivation to be a highly contributing member of a small but extremely productive team. This opportunity will offer the employee the ability to work closely with the founding team and be a part of the growth strategy of the company.
We are looking for a highly motivated and enthusiastic leader for the role of Senior Vice President of Regulatory Sciences. Reporting to the President, Co-Founder & Head of R&D, the Senior Vice President of Regulatory Sciences will build Strand's internal regulatory capabilities from the ground up. This individual will shape how we engage with domestic and global health authorities, and directly influence the pace at which we bring transformative therapies to patients. This is a highly visible role that sits at the intersection of science, strategy and execution - ideal for a leader who thrives in a fast-moving, collaborative biotech environment.
Primary Responsibilities:
- Build and lead the Regulatory Sciences function - including Global Strategy, CMC, Operations and vendor management - with a focus on scalability, speed and scientific depth.
- Own and evolve regulatory strategy for our clinical and preclinical programs, using creative, data-driven approaches that align with the scientific core of our technology.
- Serve as the company's voice in all regulatory interactions, preparing and leading health authority meetings, including FDA (CBER), TGA, EMA and other agencies.
- Shape early development decisions by partnering closely with R&D, Clinical, and Technical Operations to ensure our data packages and study designs are regulatory-ready.
- Drive innovation in regulatory science to support accelerated development paths, novel mechanisms, and next-gen therapeutic modalities.
- Be a trusted thought partner to senior leadership, contributing to portfolio prioritization, risk management, and long-range development planning.
- Foster a culture of collaboration and curiosity, mentoring teams to think strategically about regulatory science while remaining agile and pragmatic.
Qualifications:
- Bachelor's degree in a scientific discipline required; Advanced degrees (Masters, PharmD, PhD) strongly preferred.
- 20+ years of regulatory strategy experience in biotech or pharma, including building or scaling regulatory functions.
- Proven track record of success with INDs, BLAs, and global submissions; experience with expedited or accelerated designations such as RMAT, Breakthrough Therapy and/or Orphan Drug Designation highly preferred.
- Deep experience in oncology required; Experience in gene/cell therapies and/or rare disease is highly valued.
- 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 and how to apply them creatively to platform-based assets.
- Demonstrated startup mindset being comfortable operating in ambiguity, moving fast, and wearing multiple hats.
- Outstanding communication and leadership skills with a collaborative, enterprise approach.
Strand offers a fast-paced, entrepreneurial, team-focused small company environment. We also offer a top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support and more) and work/life flexibility and integration. Being part of the Strand team allows you to become part of a small team that supports professional development while working together to meet Strand's goals.
Job Type: Full-time
Salary: $365,000 - $410,000 annually plus bonus and equity incentives
Pay Transparency Base Salary Range
$365,000-$410,000 USD
