Associate Director, Clinical Scientist

Scientific Strategy & Innovation

• 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
• You will provide scientific input into the design of clinical protocols amendments and related documents.
• You will stay current with the scientific literature and competitive landscape in order 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
• You will develop innovative solutions to cross-functional challenges.

Project Delivery & Execution

• 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 start up 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
• You will lead complex clinical science activities for assigned studies serving as the primary scientific point of contact to ensure program goals are successfully met.
• You will oversee and analyze clinical trial data on an ongoing basis identifying and contributing to interpretation of trends to support clinical decisions and study conduct.
• You will 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

• You will author and review key clinical and regulatory documents including protocols Investigators 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
• You will ensure data integrity and compliance by participating in the development of case report forms (CRFs) data review plans and statistical analysis plans.
• You will 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
• You will act as a core partner to Medical Monitors Clinical Operations Biostatistics Translational and Regulatory Affairs ensuring seamless cross-functional execution.
• You will 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.

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

All your information will be kept confidential according to EEO guidelines.

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.

Remote Work :

No

Employment Type :

Full-time