Associate Director, Clinical Safety Scientist
6 months ago
**Company Description**
Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.
**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.
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 Scientist will lead the 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.
**Key Responsibilities**
- 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 MedDRA coding of AEs, assessment and follow up of SAEs including preparation of analyses of similar events (AOSE) for unexpected and related serious adverse events (SUSARs) from clinical trials.
- Contribute to regulatory authority submissions (New Drug Applications/NDAs, Marketing Authorization Applications/MAAs etc.) by reviewing safety data and preparing relevant sections of the filing and submission packages in consultation with Safety Lead and other cross functional colleagues. Assist in preparation/update of safety related global SOPs to ensure the efficient operation of the drug safety function.
**Qualifications**
- Relevant qualification within healthcare or Life Sciences or equivalent professional experience
- Have expertise and good knowledge of all phases from FIM to post approval and good working knowledge of relevant regulations (e.g. FDA, EU and ICH) and proven evidence of effective delivery of high quality documents.
- Hands-on understanding of the MedDRA and use of safety databases for adverse event evaluation and reporting
- Previous experience of managing clinical safety activities for multiple programmes and able to identify risks and propose corrective actions in complex and critical situations
- Curiosity and a solution driven approach to challenges
- Willingness to challenge and be challenged to ensure optimal decision making and delivery of solutions for patients
- Strong work ethic, decision making skills
- Exceptional teamwork skills
- Ability to work independently
**Additional Information**
- 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.
- Group income protection
- Employee assistance program
- Health Cash Plan
- Access to company subsidized gym membership.
- Eligibility for an o
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