Associate Director - Clinical Safety Operations

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Bicycle Therapeutics

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Drug Discovery • Phage Display • Peptide Therapeutics • Biotechnology

201 - 500

💰 $175M Post-IPO Equity on 2021-10

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).

Requirements

•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

Benefits

•Flexible working environment •Competitive reward including annual company bonus •Medical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the Company •Health and Dependent Care Flexible Spending Accounts •401(k) plan with a 4% Company match and immediate vesting •Eligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional days •Employee assistance program •Employee recognition schemes •10 Company holidays •Competitive Family Leave Policy •Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.