Director, Clinical Safety Scientist (Radiopharmaceuticals)
Full-time position in the Development Department.
Company Overview
Bicycle Therapeutics is a clinical‑stage pharmaceutical company developing Bicycle® molecules—fully synthetic short peptides constrained with small molecule scaffolds that form two loops stabilizing their geometry. The portfolio includes nuzafatide pevedotin (formerly 5528), zelenectide pevedotin (formerly BT8009), and BT7480, a Bicycle Tumor‑Targeted Immune Cell Agonist® targeting Nectin‑4 and agonizing CD137. Bicycle® Radioconjugates are also under development for radiopharmaceutical use. Bicycle Therapeutics is headquartered in Cambridge, UK, with key functions and leadership in Lexington, Massachusetts, USA.
Culture & Values
We are dedicated to our mission and one team. Our culture emphasizes determination and teamwork.
Role Summary
As the lead safety scientist for key assets, you will provide scientific leadership and strategic oversight for our clinical development programs with a focus on the radiopharmaceutical platform.
Clinical Safety & Scientific Leadership
* Act as the scientific safety leader for assigned compounds, including radiopharmaceuticals, throughout the clinical lifecycle.
* Lead safety evaluation activities from First‑in‑Human to later‑stage development, driving review of safety data, signal management, and presenting findings to senior management.
* Provide safety input into the design of clinical studies, shaping protocols, investigator brochures (Reference Safety Information), and informed consent forms.
Safety Governance & Risk Management
* Lead authoring of aggregate safety reports (DSURs) and implementation of Risk Management Plans (RMPs).
* Oversee pharmacovigilance vendor partners, ensuring quality and compliance in case management; lead development of Safety Management Plans.
* Provide guidance on medical coding of adverse events and lead analysis of serious adverse events, including preparation of analyses for SUSARs.
Regulatory Strategy & Submissions
* Lead preparation of safety components for major regulatory submissions (NDAs/MAAs) in partnership with regulatory affairs.
* Accountable for authoring strategic safety documents in response to requests from regulatory authorities.
Cross‑Functional Partnership & Influence
* Primary safety representative on clinical study teams; serve as subject matter expert with safety monitoring committees.
* Partner with study Medical Monitors and leaders across Clinical Development, Regulatory, and Quantitative Pharmacology for an integrated patient safety approach.
Core Skills & Competencies
Knowledge
* Recognized expertise in clinical safety science and pharmacovigilance, influencing functional strategy.
* Shape recommendations from complex safety data, including novel platforms like radiopharmaceuticals.
* Share insights from external safety landscape and mentor junior scientists.
Job Complexity
* Oversee safety for clinical programs of significant scope and complexity.
* Solve highly complex safety challenges with creative, rigorous approaches.
* Use data visualization tools (e.g., Spotfire) to present safety data.
* Shape safety strategy for our clinical portfolio and influence organization‑wide priorities.
* Set scientific safety strategy with broad autonomy.
* Make high‑impact decisions on safety risk assessment.
* Mentor peers and junior scientists as a role model for scientific excellence.
Qualifications
* Demonstrated expertise as a clinical safety scientist, with significant industry experience.
* Proven track record of providing scientific safety leadership for oncology programs across all phases (FIM to post‑approval).
* Experience with radiopharmaceuticals or other complex modalities is highly desirable.
* Deep expertise in pharmacovigilance regulations (ICH, FDA, EU, MHRA), safety databases (MedDRA), and authoring key safety documents (DSURs, RMPs, PBRERs).
* Strategic thinker with the ability to work independently and solve complex safety challenges.
* Excellent teamwork and communication skills; ability to influence and partner with cross‑functional stakeholders.
Benefits
* State‑of‑the‑art campus environment with on‑campus restaurant and Montessori nursery.
* Flexible working environment.
* Competitive reward including annual company bonus.
* 28 days annual leave plus 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.
* Enhanced parental leave policies.
* Group income protection.
* Employee assistance program.
* Health Cash Plan.
* Access to company‑subsidized gym membership.
* Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
* Cycle to work scheme.
Bicycle Therapeutics is committed to building a diverse workforce that is representative of the communities we serve. All qualified applicants will be considered for employment; we do not discriminate on the basis of race, religion, colour, gender, sexual orientation, age, disability status, marital status, or veteran status.
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