Director, Drug Safety Lead

Job Description
Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates as well as fully synthetic Bicycle systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Cambridge, MA.
Cultureis key and all Bicycle employees actively embrace and role model our company values:
WeareAdventurous.We believe it’s thewaytodeliverextraordinaryresultsforourpatients.
WeareDedicatedtoourMission.Youcan’tchangetheworldifyoudon’thavedetermination.
WeareOneTeam.Weonlysucceedwhenweworktogether.
Job Description
Drug Safety function within BicycleTX provides clinical safety and pharmacovigilance support to medicines across life cycle. Reporting to the Head of Drug Safety, this key role will lead the clinical safety activities for the assigned compounds within the organization.
You will be accountable for the implementation, execution, and management of clinical safety 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 be a recognized expert in drug safety with considerable regulatory filing experience and will be expected to work independently and to take accountability for the drug safety deliverables for the assigned molecules.
Key Responsibilities
Develop and maintain an expert understanding of the safety profile of the assigned products as well as understanding of the relevant strategic context (e.g disease under study, safety profile of competitors, mechanism of action)
Accountable for safety risk management activities for assigned product(s) in-development including defining and characterizing the safety profile (Adverse Events of Special Interest (AESIs), risk assessment/mitigation and risk management)
Provide expert safety input and review of study specific documents (e.g. protocols, IBs, IMPDs, clinical study reports, INDs, CTAs). Accountable for safety sections of regulatory documents, including but not limited to BLA/MAA/NDA, EU Risk Management plans/REMS.
In collaboration with external PV vendors and study Medical Monitor, provide oversight of clinical safety activities including medical review and assessment of SAEs, preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
Lead safety evaluation activities including First in Human (FIH) studies in collaboration with internal cross functional experts and external vendors. Ongoing signal detection, evaluation, and periodic review of emerging safety data (e.g AEs, SAEs, Labs), assess for safety trends, and timely presentation of important/urgent safety issues together with risk communication/management strategy to the company senior management including Drug Safety Committee (DSC), other internal and external stakeholders (e.g Independent Data Safety Monitoring Boards).
In collaboration with internal and external stakeholders, direct the development, preparation, and compliance of periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings), safety communications, product labelling/package inserts and other reports, as necessary
Respond to safety questions from regulatory authorities, as well as regulatory agency audits and inspections, and corrective action plans
Effectively represent ‘Drug Safety’ function across various cross-functional teams including Global Program Team (GPT)
Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.
Qualifications
Essential:
Extensive experience in clinical safety, pharmacovigilance, and risk management within the pharmaceutical industry
Educated in medicine (MD, MBBS or equivalent)
Good working knowledge of relevant regulations (e.g. FDA, EU and ICH) and proven evidence of effective delivery of high-quality documents.
Direct knowledge and hands-on experience of major filings such as BLA/MAAs
Strong analytical and problem-solving abilities, with keen attention to detail. Be able to identify risks and propose corrective actions in complex and critical situations
Have expertise and good knowledge of all phases from FIM to post approval and relevant legislations and guidelines
Willingness to challenge and be challenged to ensure optimal decision making and delivery of solutions for patients
Strong work ethic, decision making skills
Able to manage multiple and/or complex programs and coordinate the production of complex deliverables
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 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
Enhanced parental leave policies
Group income protection
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. 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 , religion, , , , ,
status, marital status, or veteran status.
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