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Data Management Director

2 months ago

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

Bicycle Therapeutics is a clinical-stage pharmaceutical company seeking a highly skilled Director of Data Management to lead our clinical safety activities. As a key member of our team, you will be responsible for implementing, executing, and managing pharmacovigilance and risk management activities for assigned compounds in conjunction with our development and commercial activities.

Key Responsibilities:
  • Lead safety evaluation activities for assigned products, including designing PV strategy and performing ongoing signal detection, evaluation, and periodic review of emerging safety data.
  • Chair the Safety Surveillance Team, facilitating review of emerging data, assessment for safety trends, decision making, and timely presentation of important/urgent safety issues to senior management and other internal and external stakeholders.
  • Provide oversight of clinical safety activities, including those performed by external PV vendors and study Medical Monitor, reviewing MedDRA coding of AEs and assessing SAEs, including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
  • 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, support regulatory agency audits and inspections, and corrective action plans.
  • Effectively represent the Drug Safety function across various cross-functional teams, including 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.
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.
  • 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.
  • 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 in addition to bank holidays, plus 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 an Equal Opportunities Employer:

We are committed to building a diverse workforce that is representative of the communities we serve. 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.