Senior Director, Data Management

Bicycle Therapeutics•Cambridge, MA

12h

About The Position

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 zelenectide pevedotin (formerly BT8009), a Bicycle® Drug Conjugate (BDC®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; 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 Cambridge, Massachusetts, USA. For more information, visit bicycletherapeutics.com 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.

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.