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Data Management Director
1 month ago
Bicycle Therapeutics is seeking a highly skilled Data Management Director to lead the clinical safety activities for assigned compounds within the organization. The successful candidate will be responsible for implementing, executing, and managing 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.
Key Responsibilities:- Perform safety risk management activities for assigned product(s) in development, including defining and characterizing the safety profile, 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.
- 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.
- 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 and support regulatory agency audits and inspections.
- A degree in medicine (MD, MBBS or equivalent) with demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry.
- The ability to understand science and biology and understand the significance of preclinical findings when planning use in man.
- Strong team working and ability to mentor and supervise less experienced members of the Drug Safety Team.
- A state-of-the-art campus environment with 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.
- 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. Therefore, all qualified applicants will be considered for employment, and we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
