Data Management Director

2 days ago

Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full time
Job Title: Director of Data Management

Bicycle Therapeutics is a clinical-stage pharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Director of Data Management to lead our clinical safety and pharmacovigilance efforts.

Key Responsibilities:
  • Lead clinical safety activities for assigned compounds, including defining and characterizing the safety profile, risk assessment, and mitigation strategy.
  • Design and implement pharmacovigilance strategies, perform ongoing signal detection, evaluation, and periodic review of emerging safety data.
  • Chair the Safety Surveillance Team, facilitate review of emerging data, assessment for safety trends, and decision-making.
  • Provide oversight of clinical safety activities, including those performed by external PV vendors and study Medical Monitor.
  • Ensure timely, compliant, and accurate safety reporting in accordance with regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP).
Requirements:
  • A degree in medicine (MD, MBBS or equivalent) with demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry.
  • Proven evidence of effective delivery of high-quality documents, as well as relevant concepts in data management and systems, epidemiology, and statistics.
  • Strong team working and ability to mentor and supervise less experienced members of the Drug Safety Team.
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.
  • Employee recognition schemes.
  • 28 days annual leave, plus bank holidays, and option to buy up to 5 additional days annually.
  • Employer contribution to pension.
  • 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. We are an equal opportunities employer and welcome applications from all qualified candidates.

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