Director, Regulatory Affairs CMC

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.

• Responsible for the development and execution of global regulatory CMC strategy and submissions for assigned BicycleTx programs or projects, including CMC dossiers to support clinical trial applications
• Responsible for the regulatory assessment of change controls, maintenance of regulatory files and tracking databases related to CMC submissions
• Collaborate 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
• Manage 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
• Developing and maintaining 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
• May 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 wi