Director, Medical Writing

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

Bicycle Therapeutics is seeking a motivated professional with oncology experience to fill a newly created position of Director of Medical Writing. The Director of Medical Writing will be responsible for leading the development and management of medical writing deliverables to support the clinical development portfolio. This position will report into the head of clinical science and will interact closely with multiple functions, including Regulatory, Drug Safety, Clinical Operations, Biometrics, Translational, Discovery, and Preclinical groups. The dynamics of a small team will allow for high visibility and will offer an opportunity to shape the role of medical writing within the organization. 

• Lead, manage, and provide and provide scientific contribution to the preparation of medical writing projects in support of the clinical development and regulatory writing portfolio, including synopses, protocols, clinical study reports, investigator brochures, development safety update reports, study charters, etc.
• Lead the writing strategy providing expertise including organization, content, timelines, and resource requirements
• Develop templates for clinical trial documents, eg protocols, ICFs, CSRs, etc.
• May provide support if needed for external publications such as abstracts and manuscripts
• Provides leadership for medical writing processes, standards, and initiatives
• Facilitates and collaborates with internal and external stakeholders in support of clinical documentation objectives
• Ensures quality and compliance with internal and external standards
• Leads or contributes to and support internal initiatives for process improvement
• May include management of external medical writing vendors

Qualifications

Essential:

• Degree in the Life Sciences
• At least 6 years of experience as a medical writer preparing clinical/regulatory documents in the pharmaceutical and/or biotech industry in the field of oncology
• Ability to prepare, without supervision, any type of clinical regulatory document (e.g., protocol, CSR, CIB, clinical sections of IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.
• In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents
• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
• Excellent written and oral communication, and project management skills.

Desirable:

• PhD in Life Sciences
• Previous management experience of external medical writing vendors

Additional Information

• State-of-the-art campus environmentwith on campus restaurant and Montessori nursery
• Flexible working environment
• Competitive reward including annual company bonus
• Employee recognition schemes
• 28 days annual l