Bicycle Therapeutics · 1 week ago
Senior Director, Data Management
Cambridge, MA
Full-time
Onsite
Director/Executive
$215K/yr - $270K/yrBicycle Therapeutics is a clinical-stage pharmaceutical company developing innovative medicines for underserved diseases. The Senior Director of Data Management is responsible for ensuring the integrity and quality of clinical trial data, leading a high-performing team, and implementing data management strategies across oncology trials.
BiotechnologyMedical DeviceTherapeutics
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
Qualification
Required
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
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.
Company
Bicycle Therapeutics
Bicycle Therapeutics is developing a technology for the creation of new generation biotherapeutics.
Founded in 2009
201-500 employees
H1B Sponsorship
Bicycle Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (3)
2023 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.1BKey Investors
Innovate UKVertex VenturesVenture Kick
2024-05-23Post Ipo Equity· $555M
2023-06-12Post Ipo Equity· $200M
2021-10-13Post Ipo Equity· $175M
Leadership Team
Kevin Lee
Chief Executive Officer
A
Alethia Young
Chief Financial Officer
Recent News
2026-01-12
2025-12-22
2025-12-18
Company data provided by crunchbase