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 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

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

Additional Information

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.

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, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.