Associate Director, Medical Writing

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:

• WeareAdventurous.We believe it’sthewaytodeliverextraordinaryresultsforourpatients.
• WeareDedicatedtoourMission.Youcan’tchangetheworldifyoudon’thavedetermination.
• WeareOneTeam.Weonlysucceedwhenweworktogether.
  
  

Bicycle Therapeutics is seeking a motivated professional with oncology experience to fill a newly created position of Associate Director of Medical Writing. The Associate Director of Medical Writing will be responsible for the development and management of medical writing deliverables to support the clinical development portfolio. This position will report into the Director of Medical Writing and will interact closely with multiple functions, including Regulatory, Drug Safety, Clinical Operations, Biometrics, Translational, Discovery, and Preclinical groups.

• Lead, manage, 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, regulatory documents etc.

• Contribute to and refine templates for clinical trial documents, eg protocols, IBs, ICFs, CSRs, etc.

• May provide support if needed for external publications such as abstracts and manuscripts

• Provide input for medical writing processes, standards, and initiatives

• Facilitate and collaborate with internal and external stakeholders in support of clinical documentation objectives

• Ensure quality and compliance with internal and external standards

• Lead orsupport internal initiatives for process improvement

• May include management of external medical writing vendors
  
  

• Advanced Degree (preferred) in the Life Sciences

• Solid experienceas 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 and/or regulatory document (e.g., protocol, IB, CSR, BTD, briefing documents, meeting requests/PIP/PSP) according to company guidelines and international governmental regulations and ability to present clinical data objectively in a clear, concise format in keeping with industry guidelines.

• Ability to coordinate and lead document roundtables, reviews, approvals, etc. during the authoring process, including technical troubleshooting as needed.

• Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, industry standard data management systems and familiarity with SharePoint and concepts of structured content management.

• Excellent written and oral communication, and project management skills

• High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously

• Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness and adheres to an overall quality framework

Desirable:

• PhD in Life Sciences

• Previous management experience of external medical writing vendors

• Original regulatory applications (IND, NDA/BLA, MAA, NDS, etc.) experience
  
  

• 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.

All your information will be kept confidential according to EEO guidelines.

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.