Director, Regulatory Affairs CMC Radiopharmaceuticals

Company Description

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 target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle Toxin Conjugate (BTC) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule 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 USA.

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 Director, Regulatory Affairs CMC will be responsible for the development, strategy, execution and tracking of CMC regulatory activities for assigned BicycleTx programs or projects. The Director, Regulatory Affairs CMC will be responsible for supporting the delivery of CMC regulatory strategy and submissions for their assigned BicycleTx programs or projects, working closely with cross-functional colleagues and the Senior Director, Regulatory Affairs CMC. As an integral member of the team that will be tasked with CMC product development, the Director, Regulatory Affairs CMC will also serve as a subject matter expert (SME) for assigned activities, which may involve multiple partners and collaborators, and will ensure adherence to relevant regulatory requirements.

Responsibilities include:

• Development and execution of global regulatory CMC strategy and submissions for assigned BicycleTx programs or projects, including CMC dossiers to support clinical trial applications.
• Regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions.
• Collaboration with internal colleagues and external organizations to develop submission content plans and timelines and support the timely execution of regulatory submissions that require CMC content, authoring of responses to questions, audits and inspections.
• Management of the preparation, drafting, review, risk analysis and mitigation planning of CMC submissions (e.g. Module 3 IND, IMPD, amendments and annual reports) for assigned BicycleTx programs or projects.
• Development and maintenance of internal cross-functional relationships to support the development and execution of CMC regulatory submissions for assigned BicycleTx programs or projects.
• May act as the Global/Regional CMC Regulatory Lead for assigned development programs.
• Support preparations and attend regulatory authority meetings for assigned development programs.
• Support the development of processes, SOPs and other controlled documents, including for Regulatory Affairs activities.
• Monitor the CMC regulatory landscape e.g., views of HAs, regulatory precedents, labeling differences and other CMC-specific issues, to anticipate and adapt to changes that may impact assigned BicycleTx programs or projects.
• Accountable for maintaining working knowledge of CMC laws, guidances and requirements relevant to assigned BicycleTx programs or projects, in addition to general regulatory knowledge.

Qualifications

• Bachelor’s degree in a scientific field or post-graduate degree preferred.
• Extensive experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry; particularly relating to peptides, drug-conjugates and/or radiopharmaceuticals; any in-depth experience may be limited to one specific region (e.g. US or EU).
• Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.
• Experience and knowledge in preparation of CMC sections of INDs, CTAs, NDAs, MAAs or regional equivalents is required.
• Experience and knowledge in the supportive interactions with health authorities, including US FDA, EMA and/or EU Member States, is desirable.
• Ability to communicate on topics of basic science is essential; an understanding of the drug product lifecycle from discovery to clinical trials to marketing is required.
• Ability to proactively identify risks and develop risk mitigation strategies.
• Adaptable with the ability to generate creative solutions, identify different and novel ways to find solutions, and adapt to changing priorities and deadlines.
• Highly collaborative, strong relationship building skills with internal and external partners, with a high level of integrity.
• Works proactively using solid communication and influencing skills to effectively execute program goals for assigned BicycleTx programs or projects.
• Works effectively in a highly complex and fast-paced environment.
• Strong organizational and time management skills.
• Position may require some domestic and international travel.

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.