Vice President Head of Regulatory Affairs

Vice President, Head of Regulatory Affairs

• Full‑time
• Department:
  Development
• Compensation: USD 290,000 – USD 365,000 per year

Bicycle Therapeutics is a clinical‑stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small‑molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates high‑affinity, high‑selectivity target binding, making Bicycle molecules attractive candidates for drug development.

The company is evaluating several programs, including a Bicycle® Drug Conjugate (BDC®) targeting Nectin‑4, a BDC molecule targeting EphA2, and a Bicycle Tumor‑Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin‑4 and CD137. Bicycle is also developing Bicycle® Radio conjugates (BRC®) for radiopharmaceutical use and exploring other applications through partnerships.

Bicycle Therapeutics is headquartered in Cambridge, UK, with key leadership functions in Cambridge, Massachusetts, USA.

All Bicycle employees actively embrace and role‑model our company values:

• We are dedicated to our mission – you can’t change the world unless you have determination.
• We are one team – we only succeed when we work together.

As a key member of the senior leadership team you will be the architect of Bicycle’s global regulatory strategy. You will lead a high‑performing team, provide vision and expertise to navigate complex regulatory landscapes, and bring our innovative medicines from development through to commercialization. As a trusted advisor to the Executive team you will be the primary interface with global health authorities, shaping a regulatory path that delivers on our ambitious corporate objectives.

• Lead, coach, and mentor the global Regulatory Affairs team, fostering a culture of high performance and psychological safety.
• Set clear strategic priorities for the function, ensuring its work aligns with departmental and organizational objectives.
• Champion the Bicycle values, serving as a role model and embedding collaboration, accountability, and innovation within your team.

• Accountable for the global regulatory strategy for the entire portfolio, translating long‑term corporate objectives into an actionable regulatory roadmap.
• Serve as a trusted advisor, coach, and strategic thought partner to the CEO and Executive team on regulatory strategy, risk, and opportunity.
• Guide assets from development through successful launch and lifecycle management, providing expert counsel on all regulatory aspects of commercialization.

• Accountable for all critical interactions and negotiations with global health authorities, including the FDA and EMA.
• Oversee the preparation and submission of all major regulatory filings, including INDs, CTAs, NDAs, and MAAs.
• Provide strategic regulatory input on all clinical development, non‑clinical, and CMC programs to ensure optimal regulatory pathways.

• Ensure robust regulatory compliance and embed best practices across the organization.
• Build and scale the regulatory function, implementing processes and systems required to support a growing, commercial‑stage organization.
• Stay at the forefront of the evolving global regulatory landscape and advise on the impact of new legislation and guidance.

• Oncology and/or radiopharmaceutical experience.
• A proven track record of successfully bringing a drug product through to marketing approval and commercialization in a senior regulatory leadership role.
• Extensive experience in regulatory affairs within the biotech or pharmaceutical industry, with deep understanding of the full drug development lifecycle.
• Demonstrated experience leading, mentoring, and scaling a high‑performing regulatory affairs team.
• Deep expertise in navigating global regulatory landscapes, with extensive experience leading direct interactions with the FDA and other major health authorities.
• Strong…