Director, Data Management

Company Description

Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications with high unmet medical need. Bicycle is headquartered in Cambridge, UK, and our US operations run out of Lexington, MA.

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. 

Job Description

The Director of Data Management (DM) will lead the clinical data management function with accountability for DM activities in Bicycle clinical studies including study set-up, capture/review/clean/delivery of clinical data and close-out. The Director of Data Management will collaborate with partner functions in Clinical Development Department (e.g., Clinical Operation, Clinical Research, Biostatistics, and Statistical Programming) and oversight the DM counterpart from vendors. This position reports to VP, Head of Biometrics. 

The ideal candidate has a demonstrated strong expertise in Clinical Data Management, advanced working experience on clinical studies in Oncology therapeutic area, as well as leadership on DM activities to support clinical development, regulatory submissions, and inspections. 

• Serve as the DM function lead 

• Responsible for all DM deliverables as the functional expert in multi-disciplinary interactions 

• Oversee the design, building, testing and maintenance of clinical study database  

• Serve as in house DM point of contact in all interactions with vendors, provide review and approval for both DM functional documents and other relevant study documents as needed, oversight vendor DM work to ensure high quality  

• Lead cross-functional collaborations on external data transfer and data integration 

• Lead on-going data review, closely monitor data quality as well as timeline, actively identify and mitigate risks 

• Responsible for the oversight of data finalization and database lock activities 

• Establish best practices, identify the need, and drive the creation of functional standard operating procedures and Work Instructions for DM function 

Qualifications

• Master’s Degree with extensive DM work experience in the pharmaceutical or biotechnology industry 

• People management experience  

• Good Clinical Practice (GCP) proficient 

• Broad and advanced knowledge of DM and relevant disciplines related to clinical development and clinical studies 

• Ability to independently manage multiple projects, strong problem-solving skills, and demonstrable leadership 

• Excellent communication skills, both written and verbal  

Additional Information

• 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
• 10 Company holidays
• Competitive Family Leave Policy
• Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.

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.