Company Description
Bicycle Therapeutics is a clinical-stage biopharmaceutical 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 target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating BT8009, a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
Culture is key and all Bicycle employees actively embrace and role model our company values:
- We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.
- We are Dedicated to our Mission. You can’t change the world if you don’t have determination.
- We are One Team. We only succeed when we work together.
Job Description
The Head of Compliance & Ethics will play a critical strategic role in building and leading the company’s compliance and ethics program, reporting to the Chief Legal Officer & General Counsel and working closely with the Executive Team. You will ensure that all corporate activities—especially those related to clinical development, medical affairs, and commercial operations—adhere to the highest legal and ethical standards. You will work cross-functionally to embed compliance principles into everyday operations, mitigating risk while fostering a culture of ethics and integrity across the organization as we scale and approach potential commercialization.
Key responsibilities:
- The Head of Compliance & Ethics serves as the key contact on issues relating to the implementation of and compliance with Bicycle’s Code of Business Conduct & Ethics and related policies
- Develop, implement, and maintain a comprehensive healthcare and corporate compliance and ethics program, ensuring alignment across all functions, including clinical development, medical affairs, and commercial teams
- Ensure compliance with global healthcare and corporate compliance related requirements, industry standards, and internal policies across all functions
- Partner with cross-functional teams to embed ethical decision-making into clinical trials, product development, and commercial strategies
- Lead healthcare and corporate compliance training programs tailored to the unique needs of the company
- Oversee healthcare and corporate compliance based risk assessments and internal audits/monitoring to proactively identify and address compliance vulnerabilities
- Collaborate with leadership to integrate compliance into strategic decision-making processes
- Manage reporting, investigations, and resolution of compliance violations
- Working closely with Regulatory Affairs teams, stay up to date with international and regional laws and regulations and ensure the company's adherence to these requirements
Qualifications
- Proven experience in healthcare and corporate compliance leadership within the biotech or pharmaceutical industry
- Strong understanding of compliance requirements, including across clinical development, medical affairs, and commercial operations
- Exceptional strategic thinking, with the ability to build and integrate compliance programs across multiple functions
- Demonstrated ability to work cross-functionally and influence diverse teams and leadership
- Strong knowledge of global regulatory and compliance standards (e.g., FDA, EMA) and healthcare laws
- Excellent leadership, communication, and interpersonal skills
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.
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.
What We Do
We are Bicycle Therapeutics, a clinical-stage biopharmaceutical company. We didn’t wait for the next advance against cancer. We created it.
Based on groundbreaking work conceived in the laboratory of Sir Greg Winter with the help of Professor Christian Heinis, we are pioneering the development of bicyclic peptides, or Bicycles® – a novel class of versatile, chemically synthesized medicines. Bicycles are fully synthetic short peptides constrained to form two loops which stabilize their structural geometry. This constraint is designed to confer high affinity and selectivity, and the relatively large surface area presented by the molecule allows targets to be drugged that have historically been intractable to non-biological approaches. Bicycles represent a unique therapeutic class, combining the pharmacological properties normally associated with a biologic with the manufacturing and pharmacokinetic advantages of a small molecule, yet with no signs of immunogenicity observed to date.
Bicycles can be used as Bicycle conjugates to deliver toxin payloads and to precisely target local immune activation within tumors and as Bicycle T-cell modulators, which activate cytotoxic T-cells while circumventing the limitations of antibody and biologic therapies and better enabling combination therapy. Our lead product candidate, BT1718, is a Bicycle toxin conjugate currently being investigated in a Phase I/IIa open label dose escalation and expansion clinical trial sponsored by Cancer Research UK. BT1718 targets Membrane Type 1 Matrix Metalloproteinase (MT1-MMP), also known as MMP-14, which is highly expressed in many solid tumors.
Our strategic collaborations are based on the ability of Bicycles to address a wide variety of targets. Through collaborations with AstraZeneca, Oxurion, Innovate UK and the Dementia Discovery Fund, we work with companies that have deep therapeutic expertise outside of oncology to enable us to more efficiently develop novel medicines for patients.
