Director of Clinical Safety

5 days ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Title: Director, Drug Safety

Bicycle Therapeutics is seeking a highly skilled Director of Clinical Safety to join our team. As a key member of our Drug Safety function, you will be responsible for leading clinical safety activities for assigned compounds and ensuring compliance with global regulations.

Key Responsibilities:
  • Develop and maintain an expert understanding of the safety profile of assigned products and relevant strategic context.
  • Perform safety risk management activities for assigned products in development, including defining and characterizing the safety profile, risk assessment, and mitigation strategy.
  • Lead safety evaluation activities for assigned products, including designing PV strategy and performing ongoing signal detection, evaluation, and periodic review of emerging safety data.
  • Collaborate with internal cross-functional experts to chair the Safety Surveillance Team, facilitate review of emerging data, and assess safety trends.
  • Provide expert safety input and review of study-specific documents and periodic and annual safety reports.
  • Ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements and Good Clinical Practice (GCP).
  • Lead response to safety questions from regulatory authorities and support regulatory agency audits and inspections.
Requirements:
  • 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.
  • The ability to understand science and biology and understand the significance of preclinical findings when planning use in man.
  • Curiosity and a solution-driven approach to challenges.
  • Strong work ethic, decision-making skills, and ability to manage multiple and/or complex programs.
What We Offer:
  • A state-of-the-art campus environment with on-campus restaurant and Montessori nursery.
  • Flexible working environment.
  • Competitive rewards, including annual company bonus and employee recognition schemes.
  • 28 days annual leave in addition to bank holidays, plus option to buy up to 5 additional days annually.
  • Employer contribution to pension and life assurance cover 4x basic salary.
  • Private Medical Insurance, including optical and dental cover.
  • Group income protection and Employee Assistance Program.
  • Health Cash Plan and 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 race, religion, color, gender, sexual orientation, age, disability status, marital status, or veteran status.

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