Senior Director, Clinical Data Management in Cambridge

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 nuzafatide pevedotin (formerly 5528), a Bicycle® Drug Conjugate (BDC®) targeting EphA2, zelenectide pevedotin (formerly BT8009), a BDC targeting Nectin-4, 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® Radioconjugates (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 Lexington, Massachusetts, 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.

The Head of Clinical Data Management is a strategic leadership role responsible for ensuring the integrity, quality, and timely delivery of all clinical trial data across our oncology portfolio. This individual will provide expert leadership and direction for data management activities, from study start-up through to database lock and regulatory submission.

This role is accountable for the development and implementation of a robust data management strategy, including the oversight of internal teams and external vendors (CROs). The ideal candidate will combine deep technical expertise in modern data management systems with a thorough understanding of the complexities of oncology clinical trials.

Strategic & Leadership:

• Develop and execute a comprehensive, forward-thinking strategy for clinical data management that aligns with the company's goals.
• Lead, mentor, and build a high-performing clinical data management team.
• Drive the selection and implementation of advanced data management technologies and systems (e.g., EDC, ePRO) to enhance efficiency and quality.
• Establish and maintain departmental SOPs, work instructions, and data standards to ensure adherence to best practices and regulatory requirements.

Operational Management:

• Oversee the entire lifecycle of clinical data management for all trials, ensuring deliverables are met on time and within budget.
• Lead the data management aspects of CRO and vendor selection, including proposal review and bid defense.
• Provide rigorous oversight of CROs and other data vendors, ensuring quality and performance standards are met.
• Manage the design and validation of clinical databases and Case Report Forms (eCRFs), ensuring they align with protocols and CDISC standards.

Data Integrity & Compliance:

• Ensure all data management activities are conducted in compliance with GCP, GCDMP, 21 CFR Part 11, and other global regulatory requirements.
• Develop and oversee data validation plans, data cleaning procedures, and discrepancy management to ensure the highest data quality.
• Oversee medical coding activities (e.g., MedDRA, WHODrug).
• Ensure all clinical data is consistently maintained in an audit-ready state and support regulatory inspections as needed.

Cross-Functional Collaboration:

• Serve as the primary data management liaison, fostering strong partnerships with Clinical Operations, Biostatistics, Pharmacovigilance, and Regulatory Affairs.
• Collaborate with clinical and research teams to address the unique data requirements of oncology trials, including biomarkers, genomics, and imaging data.

Qualifications:

• Demonstrable progressive experience in clinical data management within the pharmaceutical or biotechnology industry.
• Extensive experience in oncology clinical trials across all phases (I-IV) is required.
• Proven track record of successfully leading data management functions and teams.
• Significant experience in overseeing and managing CROs and other external data vendors.
• Experience with NDA, BLA, or other regulatory submissions is highly desirable.
• Expert knowledge of EDC systems (e.g., Medidata Rave, Veeva) and other clinical data technologies.
• Comprehensive knowledge of international regulatory requirements and guidelines (e.g., FDA, EMA, ICH/GCP).
• Exceptional leadership, communication, and project management skills.
• Demonstrated ability to think strategically while maintaining a strong attention to detail.

Key Competencies & Skills:

• Knowledge & Expertise: Core Expertise: You guide the professional strategy for data management across multiple functions, shaping the company’s long-term approach to clinical data.
• Data / Insight: You provide foresight and strategic interpretation of complex industry trends and data system capabilities to guide our long-term technology and data strategy.
• Knowledge Sharing: You act as a thought leader, representing Bicycle's data strategy internally and externally to enhance our scientific and operational reputation.

Job Complexity:

• Task / Project Delivery: You oversee the entire portfolio of data management activities, ensuring the successful delivery of clean, reliable data for all clinical programs.
• Problem-Solving: You solve systemic, organisation-wide challenges, such as designing a next-generation clinical data warehouse or creating a strategy for integrating novel data sources.
• Strategic Impact: You contribute directly to the R&D and corporate strategy by ensuring a cutting-edge, well-executed data management approach is embedded across our pipeline.

Independence:

• Autonomy: You independently shape the cross-functional direction for clinical data management, partnering with senior leaders in IT and Clinical to drive our data vision.
• Decision-Making: You make enterprise-level decisions regarding data systems, vendors, and strategic priorities that have organisation-wide implications.

Leadership / Mentorship:

• You develop future leaders within your function, coaching senior data managers and ensuring robust succession planning.

Values & Behaviours at Bicycle:

We are driven by our mission and our culture is key to our success at Bicycle. Our employees embrace and role model our values, and at Senior Director level we would expect you to show:

• One Team: Collaboration: You create alignment across multiple teams and functions, ensuring the data management function is a strategic partner to clinical development, research, and other key areas.
• Inclusive Leadership: You embed inclusivity and collaboration into the organisational culture, fostering a data-driven environment where diverse ideas on data handling and technology are valued.
• Mentorship / Support: You coach senior leaders and data management experts, actively engaging in succession planning to build our future leadership pipeline in data excellence.

Adventurous:

• Innovation: You champion the adoption of emerging data technologies and practices, driving the transformation of how we collect, manage, and leverage clinical data.
• Risk-Taking: You take calculated risks to position the organisation for success, such as investing in new data platforms or methodologies to enhance efficiency and insight.
• Change Leadership: You lead the organisation confidently through major data system implementations, process overhauls, and other technological transformations.

Dedicated to our Mission:

• Accountability: You ensure organisational priorities for data integrity, quality, and governance remain directly aligned with our mission to deliver robust and reliable clinical trial results.
• Resilience: You sustain focus and determination during high-stakes challenges, such as database locks, complex data migrations, or regulatory inspections.
• Inspiration: You inspire organisation-wide commitment to data quality and excellence, articulating a compelling vision that connects this work directly to patient safety and successful drug development.

Additional Information:

• State-of-the-art campus environment with on campus restaurant and Montessori nursery.
• Flexible working environment.
• Competitive reward including annual company bonus.
• Employee recognition schemes.
• 28 days annual leave in addition to 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.

We are 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.