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® Radioconjugates (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.

Culture

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.

Mission & Leadership

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.

Strategic Regulatory Leadership & Executive Partnership

• 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.

Regulatory Execution & Agency Engagement

• 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.

Regulatory Excellence & Compliance

• 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.

Qualifications & Experience

• 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 executive presence and communication skills, acting as a credible, influential advisor to an Executive team.

Skills & Competencies

• Core expertise: shape the professional vision for the organization, acting as a key member of the senior leadership team.
• Data / insight: use insight to anticipate organizational and industry trends, guiding long‑term regulatory strategy.
• Knowledge sharing: contribute to sector‑wide standards and best practices, representing the organization as a thought leader.

Job Complexity

• Task / Project delivery: lead enterprise‑wide programs and priorities, translating corporate objectives into a cohesive regulatory roadmap.
• Problem‑solving: resolve the most complex regulatory challenges with long‑term, strategic impact.
• Strategic impact: influence organizational and industry direction, ensuring the regulatory agenda is fully integrated with the business strategy.
• Autonomy: operate with broad authority to shape organizational strategy as a strategic thought partner to the CEO and Executive team.
• Decision‑making: take responsibility for high‑risk, high‑reward regulatory decisions that shape the future of the organization.
• Leadership / mentorship: empower senior leaders, build a strong leadership culture, and create opportunities for future leaders to emerge.

Benefits & Compensation

• Salary Range: $290,000 – $365,000 per year.
• Discretionary annual bonus program (or sales incentive program); comprehensive health and retirement benefit programs; equity grants.
• Competitive reward including annual company bonus.
• Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the company.
• Health and dependent care flexible spending accounts.
• 401(k) plan with a 4% company match and immediate vesting.
• Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days.
• Employee assistance program.
• 10 company holidays.
• Competitive family leave policy.
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

We have shared the expected recruitment base pay range for this full‑time position based on the anticipated location. The actual base pay will depend on several unique factors. At Bicycle, base pay is just one component of the total reward package. This role is also eligible for Bicycle’s discretionary annual bonus program (or sales incentive program), its comprehensive health and retirement benefit programs, and equity grants. During the hiring process, your Bicycle recruiter can share more about the Company’s total reward package.

Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, all qualified applicants will be considered employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.

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