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Director (m/w/d) Software Development
4 months ago
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. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. 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.
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
Provides leadership for medical writing processes, standards, and initiatives
Ensures quality and compliance with internal and external standards
May include management of external medical writing vendors
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.
PhD in Life Sciences
Previous management experience of external medical writing vendors
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 leave in addition to bank holidays+ option to buy up to 5 additional days annually
~ Employer contribution to pension (employee does not have to contribute)
~ Life assurance cover 4x basic salary
~ Private Medical Insurance, including optical and dental cover.
~ Employee assistance program
~ Health Cash Plan
~ Access to company subsidized gym membership.
~ Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
~ Cycle to work scheme
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. 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.
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