Data Management Director
9 hours ago
Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative medicines for underserved diseases. Our commitment to excellence drives us to seek a highly skilled Director of Data Management to lead our clinical safety activities.
Key Responsibilities:- Develop and implement pharmacovigilance and risk management strategies for assigned compounds
- Lead safety evaluation activities, including designing PV strategies and performing signal detection and evaluation
- Chair the Safety Surveillance Team and facilitate review of emerging data, assessment of safety trends, and decision-making
- Provide oversight of clinical safety activities, including review of MedDRA coding and assessment of SAEs
- Ensure timely, compliant, and accurate safety reporting in accordance with regulatory requirements
- MD, MBBS, or equivalent degree with experience in clinical safety, pharmacovigilance, and risk management
- Proven track record of delivering high-quality documents and relevant concepts in data management and systems, epidemiology, and statistics
- Ability to understand science and biology, and the significance of preclinical findings when planning use in man
- Strong team working and mentoring skills, with the ability to supervise less experienced team members
- 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 option to buy up to 5 additional days annually
- Employer contribution to pension, life assurance cover, and private medical insurance
Bicycle Therapeutics is committed to building a diverse workforce that reflects the communities we serve. We welcome applications from qualified candidates and are an equal opportunities employer.
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