Data Management Director
1 day ago
Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative medicines for underserved diseases. As a key member of our team, you will play a crucial role in shaping the future of our organization.
Job Summary:We are seeking an experienced Director of Data Management to lead our clinical safety activities and implement pharmacovigilance and risk management strategies for our assigned compounds. The successful candidate will have a strong background in drug safety, pharmacovigilance, and risk management, with excellent communication and leadership skills.
Key Responsibilities:- Develop and implement pharmacovigilance and risk management strategies for assigned compounds
- Lead safety evaluation activities, including designing PV strategies and performing ongoing signal detection, evaluation, and periodic review of emerging safety data
- Chair the Safety Surveillance Team and facilitate review of emerging data, assessment for safety trends, decision making, and timely presentation of important/urgent safety issues
- 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 applicable regulatory requirements, Good Clinical Practice (GCP), and standard operating procedures (SOP)
- MD, MBBS, or equivalent degree in medicine
- Demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry
- Proven evidence of effective delivery of high-quality documents and relevant concepts in data management and systems, epidemiology, and statistics
- 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
- 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, plus bank holidays, and 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
- Employee assistance program and 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 welcome applications from all qualified candidates and 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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