Director, Drug Safety

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

The Drug Safety function within BicycleTX provides clinical safety and pharmacovigilance support to medicines across the product life cycle. Reporting to the VP of Drug Safety, this key role will lead the clinical safety activities for the assigned compounds within the organization and is responsible for the implementation, execution, and 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 be an expert in drug safety and will be expected to work independently and provide input to cross functional teams to take accountability for all drug safety deliverables for the assigned molecules.

Developing and maintaining 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);
Working with other assigned members of the team, perform 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 strategy and risk management);
Lead safety evaluation activities for assigned products including designing PV strategy and performing ongoing signal detection, evaluation, and periodic review of emerging safety data (e.g AEs, SAEs, Labs);
In collaboration with internal cross functional experts (e.g. Clinical development, regulatory, clinical pharm, toxicology), chair the Safety Surveillance Team, facilitate review of emerging data, assessment for safety trends, decision making and timely presentation of important/urgent safety issues together with risk communication/management strategy to the company senior management and other internal and external stakeholders (e.g Independent Data Safety Monitoring Boards);
Working with cross functional colleagues or external vendors, provide expert safety input and review of study specific documents (e.g. protocols, IBs, IMPDs, clinical study reports, INDs, CTAs) and periodic and annual safety reports (e.g., DSUR, PSUR, periodic line listings), investigator communications and other reports, as necessary;
Provide oversight of clinical safety activities including those performed by external PV vendors and study Medical Monitor including review of MedDRA coding of AEs, and assessment of SAEs including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials;
Working with external PV vendors, ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP);
Lead response to safety questions from regulatory authorities, as well as support regulatory agency audits and inspections, and corrective action plans;
Effectively represent ‘Drug Safety’ function across various cross-functional teams (e.g. clinical development, clinical pharmacology, toxicology and regulatory);
Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.

Qualifications

A degree in medicine (MD, MBBS or equivalent) with demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry;
Good knowledge of relevant regulations (e.g. FDA, EU and ICH) and proven evidence of effective delivery of high quality documents, as well as relevant concepts in data management and systems, epidemiology and statistics;
The ability to understand science and biology and understand the significance of preclinical findings when planning use in man. Act without oversight in most circumstances as well as provide key input to difficult or sensitive projects;
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;
Curiosity and a solution driven approach to challenges;
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;
Strong team working and ability to mentor and supervise less experienced members of the Drug Safety Team.

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