Director of Clinical Safety
6 hours ago
Bicycle Therapeutics is a clinical-stage pharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Director of Drug Safety to join our team and lead our clinical safety activities.
Job SummaryThe Director of Drug Safety will be responsible for leading the clinical safety function within Bicycle Therapeutics, providing expert guidance on pharmacovigilance and risk management activities. This role will involve developing and implementing safety strategies, managing safety data, and collaborating with cross-functional teams to ensure compliance with global regulations.
Key Responsibilities- Develop and maintain an expert understanding of the safety profile of assigned products, including adverse event management and risk assessment.
- Lead safety evaluation activities, including designing pharmacovigilance strategies and performing ongoing signal detection and evaluation.
- Collaborate with internal cross-functional experts to chair the Safety Surveillance Team, facilitate review of emerging data, and assess safety trends.
- Provide expert safety input and review of study-specific documents, including protocols, investigator brochures, and clinical study reports.
- Ensure timely, compliant, and accurate safety reporting in accordance with applicable regulatory requirements and Good Clinical Practice (GCP).
- MD or equivalent degree with demonstrable experience in clinical safety, pharmacovigilance, and risk management within the biotech/pharmaceutical industry.
- Good knowledge of relevant regulations (e.g. FDA, EU, and ICH) and proven evidence of effective delivery of high-quality documents.
- Ability to understand science and biology, as well as the significance of preclinical findings when planning use in man.
- Strong work ethic, decision-making skills, and ability to manage multiple and/or complex programs.
- 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 is representative of the communities we serve. We recognize that diverse and inclusive teams build a stronger and more innovative company. Therefore, 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.
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Director of Clinical Safety
1 day ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Director, Drug SafetyBicycle Therapeutics is a clinical-stage pharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Director of Drug Safety to join our team.Job SummaryThe Director of Drug Safety will lead the clinical safety activities for our assigned compounds, ensuring...
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Director of Clinical Safety
1 day ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Director, Drug SafetyBicycle Therapeutics is a clinical-stage pharmaceutical company dedicated to developing innovative medicines for underserved diseases. We are seeking a highly skilled Director of Drug Safety to join our team.Job SummaryThe Director of Drug Safety will lead the clinical safety activities for our assigned compounds, ensuring...
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Clinical Safety Director
1 day ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Clinical Safety DirectorBicycle Therapeutics is seeking a highly skilled Clinical Safety Director to lead our Drug Safety function. As a key member of our team, you will be responsible for ensuring the safe development and marketing of our medicines.Key Responsibilities:Develop and maintain an expert understanding of the safety profile of our...
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Clinical Safety Director
1 day ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeJob Title: Clinical Safety DirectorBicycle Therapeutics is seeking a highly skilled Clinical Safety Director to lead our Drug Safety function. As a key member of our team, you will be responsible for ensuring the safe development and marketing of our medicines.Key Responsibilities:Develop and maintain an expert understanding of the safety profile of our...
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