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Associate Director, Pharmacovigilance Scientist
4 months ago
Job 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. 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.
The Drug Safety function within Bicycle Therapeutics provides clinical safety and pharmacovigilance support to medicines across life cycle.
Reporting to the Head of Drug Safety, the Associate Director, Clinical Safety Scientist will lead the clinical safety activities for the assigned compounds within the organization. Responsible for the implementation and the management of pharmacovigilance and risk management activities for assigned compounds in conjunction with the Company's development and planned commercial activities, industry standards, and compliance with global regulations.
You will work with the Safety Lead to actively manage and evaluate risks associated with assigned projects and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks.
Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.
Manage safety responsibilities on clinical study teams and provide input to clinical teams concerning safety aspects of the design and preparation of protocols, investigators brochures, informed consent forms and investigator notification letters.
Safety evaluation activities including First in Human (FIH) studies in collaboration with Safety lead, internal cross functional experts and external vendors. Regular review of emerging safety data and timely presentation of important/urgent safety issues to the company senior management, other internal and external stakeholders (e.g Safety Monitoring Committee, Independent Data Safety Monitoring Boards)
Responsible for authoring and/or review of aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
Contribute to and summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, DSURs, PBRERs and RMPs).
Responsible for coordination and collaboration with external vendors servicing Bicycle Drug Safety; create/review Safety Management Plans (SMP) for the assigned projects and oversee clinical safety case management, aggregate reports and reconciliation for quality and compliance.
In collaboration with external PV vendors and study Medical Monitor, review of MedDRA coding of AEs, assessment and follow up of SAEs including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
Contribute to regulatory authority submissions (New Drug Applications/NDAs, Marketing Authorization Applications/MAAs etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with Safety Lead and other cross functional colleagues.
Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.
Relevant qualification within healthcare or Life Sciences or equivalent professional experience
FDA, EU and ICH) and proven evidence of effective delivery of high quality documents.
Hands-on understanding of the MedDRA and use of safety databases for adverse event evaluation and reporting
Previous experience of managing clinical safety activities for multiple programmes and able to identify risks and propose corrective actions in complex and critical situations
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.
