Job Description

As a key member of the senior leadership team, your mission is to be the architect of Bicycle’s global regulatory strategy. You will lead a high-performing team, providing the vision and expertise required to navigate complex regulatory landscapes and successfully 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.

Team Leadership & Development

• You will lead, coach, and mentor the global Regulatory Affairs team, investing in their professional growth and fostering a culture of high performance and psychological safety.
• You will set clear strategic priorities for the function, ensuring its work is directly aligned with departmental and organizational objectives.
• You will champion the Bicycle Values, acting as a role model and embedding a culture of collaboration, accountability, and innovation within your team.

Strategic Regulatory Leadership & Executive Partnership

• You will be accountable for the global regulatory strategy for our entire portfolio, translating long-term corporate objectives into a cohesive and actionable regulatory roadmap.
• You will serve as a trusted advisor, coach, and strategic thought partner to the CEO and Executive team on all matters related to regulatory strategy, risk, and opportunity.
• You will guide assets from development through to successful launch and lifecycle management, providing expert counsel on all regulatory aspects of commercialization.

Regulatory Execution & Agency Engagement

• You will be accountable for all critical interactions and negotiations with global health authorities, including the FDA and EMA.
• You will be accountable for the oversight, preparation, and submission of all major regulatory filings, including INDs, CTAs, NDAs, and MAAs.
• You will provide strategic regulatory input on all clinical development, non-clinical, and CMC programs to ensure optimal regulatory pathways.

Regulatory Excellence & Compliance

• You will ensure robust regulatory compliance and best practices are embedded across the organization.
• You will build and scale the regulatory function, implementing the processes and systems required to support a growing, commercial-stage organization.
• You will stay at the forefront of the evolving global regulatory landscape and advise the business on the potential impact of new legislation and guidance.

Qualifications

• 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 is essential.
• Extensive experience in regulatory affairs within the biotech or pharmaceutical industry, with a 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, with the ability to act as a credible, influential advisor to an Executive team.

Essential:

• Oncology[NM1] [MM2] 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 is essential.
• Extensive experience in regulatory affairs within the biotech or pharmaceutical industry, with a 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, with the ability to act as a credible, influential advisor to an Executive team.

WHO YOU ARE: SKILLS & COMPETENCIES

Knowledge

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

Job Complexity

• Task / Project Delivery: You lead enterprise-wide programs and priorities, translating corporate objectives into a cohesive regulatory roadmap.
• Problem-Solving: You resolve the most complex regulatory challenges with long-term, strategic impact.
• Strategic Impact: You influence organizational and industry direction, ensuring the regulatory agenda is fully integrated with the business strategy.

Independence

• Autonomy: You operate with broad authority to shape organizational strategy as a strategic thought partner to the CEO and Executive team.
• Decision-Making: You take responsibility for high-risk, high-reward regulatory decisions that shape the future of the organization.
• Leadership / Mentorship: You empower senior leaders, build a strong leadership culture, and create opportunities for future leaders to emerge.

Additional Information

• Flexible working environment
• 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
• Employee recognition schemes
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

Compensation:

• Salary Range: $290,000 - $365,000

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 factors unique to each candidate, including skills, qualifications, experience, and the actual location of the role. 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 for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.