Associate Director/Director, Drug Safety Operations
1 month ago
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are seeking an experienced Associate Director/Director, Drug Safety Operations to lead our clinical safety operations activities.
This role will oversee all safety operations activities, including vendor management, audits, SOPs, and trainings. The successful candidate will assure all respective safety SOPs are in place and provide training to vendors, clinical sites, and internal teams.
Key Responsibilities:
- Lead and oversee all safety operations activities, including vendor management, audits, SOPs, and trainings.
- Assure all respective safety SOPs are in place and provide training to vendors, clinical sites, and internal teams.
- Manage clinical safety activities for assigned compounds within the organization.
- Implement and manage pharmacovigilance and risk management activities for assigned compounds in conjunction with the Company's development and planned commercial activities.
- Work with the Safety Lead to actively manage and evaluate risks associated with assigned projects and make recommendations for the management and communication of risks in accordance with global legal and regulatory frameworks.
Requirements
- Previous experience of managing clinical safety activities for multiple programmes and able to identify risks and propose corrective actions in complex and critical situations.
- 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.
About Bicycle Therapeutics
Bicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. We are committed to building a diverse workforce that is representative of the communities we serve.
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