Senior Director, Data Management

Bicycle Therapeutics • Cambridge, MA

83d

About The Position

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.

Requirements

• 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.

Responsibilities

• 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.
• 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.
• 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.
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree