Associate Director, Clinical Safety Operations

Company Description

Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BTC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle® Radio Conjugates (BRC™) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle® technology to develop therapies for diseases beyond oncology.

Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA USA

Culture is key and all Bicycle employees actively embrace and role model our company values: 

• We are Adventurous. We believe it’s the way to deliver extraordinary results for our patients.   
• We are Dedicated to our Mission. You can’t change the world if you don’t have determination. 
• We are One Team. We only succeed when we work together.  

Job Description

The Drug Safety function within Bicycle Therapeutics provides clinical safety and pharmacovigilance support to medicines across life cycle.

Reporting to the Head of Drug Safety, the Associate Director, Clinical Safety Operations Scientist will lead and oversee all safety operations activities including vendor management, audits, SOPs, trainings. They will assure all respective safety SOPs are in place. The Associate Director will provide all training to the vendors, clinical sites and internally. In addition will manage all clinical safety activities for the assigned compounds within the organization. Responsible for the implementation and the management of 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.

You will 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.

• Responsible for coordination, management, and collaboration with external vendors servicing Bicycle Drug Safety; create/review Safety Management Plans (SMP) for the assigned projects and oversee clinical safety case management, aggregate reports and reconciliation for quality and compliance. Assure full compliance from the vendors.
• Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.
• Manage audits (external/internal) assuring a full compliance.
• Other activities as deemed necessary per Head of PV.
• Develop and maintain an understanding of the safety profile of their assigned product(s) or therapy areas.
• Manage safety responsibilities on clinical study teams and provide input to clinical teams concerning safety aspects of the design and preparation of protocols, investigators brochures, informed consent forms and investigator notification letters.  
• Safety evaluation activities including First in Human (FIH) studies in collaboration with Safety lead, internal cross functional experts and external vendors. Regular review of emerging safety data and timely presentation of important/urgent safety issues to the company senior management, other internal and external stakeholders (e.g Safety Monitoring Committee, Independent Data Safety Monitoring Boards)
• Responsible for authoring and/or review of aggregate safety assessments and drug safety reports for signals/issues or in response to Regulatory Authority requests.
• Contribute to and summarize safety data effectively for use in regulatory or clinical trial documents (e.g. ad-hoc queries, DSURs, PBRERs and RMPs).
• Responsible for coordination and collaboration with external vendors servicing Bicycle Drug Safety; create/review Safety Management Plans (SMP) for the assigned projects and oversee clinical safety case management, aggregate reports and reconciliation for quality and compliance.
• In collaboration with external PV vendors and study Medical Monitor, review of