Senior Vice President of Regulatory Sciences

Strand Therapeutics; Boston (MA); Vor Ort; USD 365.000 - 410.000; Vollzeit

Benefits dieser Stelle

Health, dental, life insurance

Open PTO

Onsite lunch catering

Commuter support

Equity incentives

Zusammenfassung

Strand Therapeutics is seeking a Senior Vice President of Regulatory Sciences to build internal capabilities and drive regulatory strategy across clinical and preclinical programs. This leadership role reports to the President, Co-Founder & Head of R&D and will shape interactions with domestic and global health authorities.

The position sits at Strand's Boston headquarters, requiring a deep background in regulatory science for biotech or gene/cell therapies and a startup mindset to move quickly

Qualifikationen

• 20+ years of regulatory strategy experience in biotech or pharma.
• Experience with INDs, BLAs, and global submissions.
• Deep oncology experience; gene/cell therapies and/or rare disease valued.
• Hands-on experience with FDA entities (CBER) and global health authorities.
• Startup mindset; comfortable operating in ambiguity and wearing multiple hats.
• Outstanding communication and leadership skills with an enterprise mindset.

Aufgaben

• Build and lead Regulatory Sciences with Global Strategy, CMC, Operations and vendor management.
• Own regulatory strategy for clinical and preclinical programs; align with scientific core.
• Serve as the company voice in regulatory interactions with health authorities.
• Shape early development decisions by partnering with R&D, Clinical, and Technical Operations.
• Drive innovation in regulatory science to support accelerated development paths.
• Mentor teams and collaborate with senior leadership; foster collaboration and agility.

Kenntnisse

Regulatory leadership

Communication

Strategic thinking

Ausbildung

Bachelor's degree

Advanced degree (Masters, PharmD, PhD)

Jobbeschreibung

Company Overview:

Strand Therapeutics is a clinical-stage biotechnology company pioneering programmable mRNA therapeutics to unlock the full potential of genetic medicines. Strand is applying its proprietary Signal Stack platform, which integrates EverScript circular RNA, AmpliScript self-replicating RNA, SignalPath targeted delivery, and logic-driven SignalLock genetic circuits to enable precise control of therapeutic activity across tissues and cell types and overcome foundational limitations in targeting, durability, and safety.

Strand is advancing a pipeline with an initial focus on oncology and autoimmune disease. Its initial program, STX-001, an intratumorally delivered LNP-encapsulated self-replicating RNA expressing IL-12, has demonstrated preliminary evidence of systemic immune activation and anti-tumor activity in patients with advanced solid tumors who have progressed on prior therapies. Building on this early clinical validation, intravenously delivered STX-003 is designed for tumor-targeted expression and avoidance of off-target expression. STX-003, which is expected to enter the clinic in mid-2026, has the potential to be a major step forward for the fields of genetic medicine and oncology.

Strand is also advancing STX-005, in vivo CAR‑T program designed to enable controlled, durable expression and repeat dosing. Founded by MIT synthetic biology pioneers, Strand has raised over $250 million and is headquartered in Boston, MA.

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.

Strand Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Strand does not accept unsolicited resumes from any source other than directly from candidates.

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