Director, Clinical Safety Scientist (Radiopharmaceuticals)

Director, Clinical Safety Scientist (Radiopharmaceuticals)

Bicycle Therapeutics

Cambridge, United Kingdom

Job Description

As the lead safety scientist for key assets within our innovative portfolio, your mission is to provide expert scientific leadership and strategic oversight for our clinical development programs, with a particular focus on our radiopharmaceutical platform. Reporting to the Head of Drug Safety, you will be the subject matter expert responsible for shaping and managing the safety profile of assigned compounds, ensuring patient safety remains at the forefront of all our development activities.

Clinical Safety & Scientific Leadership

• You will act as the scientific safety leader for assigned compounds, including radiopharmaceuticals, leading the development and maintenance of their safety profiles throughout the clinical lifecycle.
• You will lead all safety evaluation activities, from First-in-Human studies through to later-stage development, driving the regular review of emerging safety data and safety signal management, and presenting critical findings to senior management and governance bodies.
• You will provide expert safety input into the design of clinical studies, shaping key documents such as protocols, investigator brochures including the Reference Safety Information, and informed consent forms.

Safety Governance & Risk Management

• You will lead the authoring of aggregate safety reports (e.g., DSURs) and drive the development and implementation of Risk Management Plans (RMPs).
• You will oversee our pharmacovigilance vendor partners for your assigned programs, ensuring quality and compliance in case management, and you will lead the development of Safety Management Plans.
• You will provide expert guidance on the medical coding of adverse events and lead the analysis of serious adverse events, including the preparation of analyses of similar events for SUSARs.

Regulatory Strategy & Submissions

• You will lead the preparation of the safety components for major regulatory submissions (e.g., NDAs/MAAs), working in partnership with regulatory affairs and other cross-functional colleagues.
• You will be accountable for authoring strategic safety documents in response to requests from Regulatory Authorities.

Cross-Functional Partnership & Influence

• You will act as the primary safety representative on clinical study teams and serve as the subject matter expert in interactions with external groups such as Safety Monitoring Committees and Independent Data Monitoring Committees.
• You will work in close partnership with the study Medical Monitors and other leaders across Clinical Development, Regulatory, and Quantitative Pharmacology to provide a fully integrated approach to patient safety.

Core Skills & Competencies

Knowledge

• Core Expertise: You provide recognized expertise in clinical safety science and pharmacovigilance, influencing the functional strategy for our clinical programs.
• Data/Insight: You shape clear recommendations from complex and often ambiguous clinical safety data, including from novel platforms like radiopharmaceuticals.
• Knowledge Sharing: You share insights from the external safety landscape that strengthen our organizational capability and mentor junior scientists.

Job Complexity

• Task/Project Delivery: You oversee safety for clinical programs of significant scope and complexity, ensuring robust safety oversight for our key assets.
• Problem-Solving: You solve highly complex safety challenges, such as evaluating novel safety signals, with creative and scientifically rigorous approaches.
• Data visualization and analysis: You are comfortable with using data visualization tools, such as Spotfire etc., to present emerging safety data in an accessible format.
• Strategic Impact: You shape the safety strategy for our clinical portfolio and influence organization-wide priorities related to patient safety.

Independence

• Autonomy: You set the scientific safety strategy for your assigned compounds with broad autonomy.
• Decision-Making: You make high-impact decisions regarding the assessment of safety risks in often uncertain contexts.
• Leadership/Mentorship: As a senior scientific expert, you empower peers and mentor junior scientists, acting as a role model for scientific excellence.

Qualifications

• Demonstrated expertise as a clinical safety scientist, gained through significant experience within the biotech or pharmaceutical industry.
• A proven track record of providing scientific safety leadership for oncology programs across all phases of clinical development, from FIM to post-approval.
• Experience with radiopharmaceuticals or other complex modalities is highly desirable
• Deep expertise in pharmacovigilance regulations globally (ICH, FDA, EU, MHRA), safety databases (including MedDRA), and the authoring of key safety documents (DSURs, RMPs, PBRERs).
• A strategic thinker with the ability to work independently and a history of solving complex safety challenges.
• Excellent teamwork and communication skills, with the ability to influence and partner effectively with cross-functional stakeholders.