Associate Director, Clinical Scientist

Role Summary

Associate Director, Clinical Scientist

Responsibilities

• Participate in strategy, design, authoring, and review of clinical documents, including protocols, amendments, informed consent forms, clinical study reports, investigator brochures, drug safety update reports, and clinical development plans
• Provide scientific input into the design of clinical protocols, amendments, and related documents
• Stay current with the scientific literature and competitive landscape to contribute to clinical development strategy
• Perform literature searches and critically review and summarize results to support activities such as document development, new indications for a given molecule, and competitive intelligence
• Develop innovative solutions to cross-functional challenges
• Contribute to clinical study design and conduct for development of novel tumor antigen-targeted Bicycle therapeutics
• Lead medical and safety data review and associated meetings in collaboration with the Medical Monitor, review and query data
• Participate in study startup, including identification of investigators/sites, feasibility, review of CRF, etc
• Develop content and give presentations during site initiation visits; participate in site training
• Support internal initiatives to develop best practices, lessons-learned, problem-solving, and risk mitigation
• Lead complex clinical science activities for assigned studies, serving as the primary scientific point of contact to ensure program goals are successfully met
• Oversee and analyze clinical trial data on an ongoing basis, identifying and contributing to interpretation of trends to support clinical decisions and study conduct
• Ensure alignment with organisational priorities by collaborating with Clinical Operations to ensure timely and high-quality study execution in line with the clinical development plan

Data, Documentation & Compliance

• Author and review key clinical and regulatory documents, including protocols, Investigator's Brochures (IBs), clinical study reports (CSRs), and sections of regulatory filings (e.g., INDs, NDAs)
• Contribute to regulatory documents, including INDs and briefing books and other regulatory documents
• Contribute to publication strategy and provide support for publication of data
• Ensure data integrity and compliance by participating in the development of case report forms (CRFs), data review plans, and statistical analysis plans
• Present scientific data to internal governance bodies, project team

Collaboration & Stakeholder Management

• Serve as a liaison between study team, CROs, and investigators
• Assist in preparing material for advisory boards, conference activities, external collaborations, and partnerships
• Potential to mentor other clinical scientists
• Attend congresses as needed to support publications as well as interactions with key opinion leaders and investigators
• Act as a core partner to Medical Monitors, Clinical Operations, Biostatistics, Translational and Regulatory Affairs, ensuring seamless cross-functional execution
• Build strong relationships with clinical investigators and key opinion leaders, acting as a key scientific representative for Bicycle

Qualifications

• Advanced scientific or clinical degree (e.g., MS, PhD, PharmD, nursing, or equivalent) with experience in a clinical science or clinical development role within the biotech or pharmaceutical industry
• Ability to be onsite on a hybrid basis
• Experience in the design and execution of clinical trials, with a deep understanding of protocol development, data analysis, and study reporting
• Thorough knowledge of GCP, ICH guidelines, and regulatory requirements for clinical development
• Demonstrated ability to interpret complex scientific and clinical data and translate it into actionable strategies
• Experience in oncology is essential
• Experience with radiopharmaceuticals or radioconjugates is highly desirable

Knowledge

• Core Expertise: You are a subject matter expert in clinical science, applying specialized experience to guide teams and projects
• Data / Insight: You provide interpretation of clinical data and its implications, using your analysis to make significant recommendations
• Knowledge Sharing: You act as a mentor and role model for best practice in clinical study design and execution

Job Complexity

• Task / Project Delivery: You lead large, complex clinical projects or programs that directly impact company success
• Problem-Solving: You are a proficient problem-solver, developing innovative solutions to complex scientific and operational challenges in clinical development
• Strategic Impact: You contribute to shaping functional priorities and strategy, ensuring clinical activities align with corporate goals

Independence

• Autonomy: You operate with high independence, setting the scientific direction for your assigned clinical studies and making key decisions with limited guidance
• Decision-Making: You make significant decisions within broad guidelines, exercising sound judgment in data interpretation and study conduct
• Leadership / Mentorship: As an established technical leader, you coach and mentor other clinical science colleagues, helping to develop talent within the function

Values & Behaviours

• Collaboration (One Team): You build strong, collaborative partnerships across all functions of clinical development, creating an environment that empowers teams
• Innovation (Adventurous): You are ambitious in driving positive change, encouraging creative thinking and experimentation in clinical study design
• Accountability (Dedicated to our Mission): You ensure team outcomes align with our mission priorities, demonstrating passion for delivering impactful results for patients