Associate Director, Data Management

Job Description

Job Description

Company Description

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® Toxin Conjugate (BTC®) targeting Nectin-4, a well-validated tumor antigen;

BT5528, a BTC 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® Radio Conjugates (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, MA 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.

Job Description

The Associate Director of Data Management (DM) will act as the lead of one or several programs with accountability for all DM activities in Bicycle clinical studies including study set-up, capture / review / clean / delivery of clinical data and close-out.

The Associate director of Data Management is responsible for timely and high-quality data management deliverables supporting the Bicycle Portfolio.

The Associate Director of Data Management will report to the Director of Data Management.

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 contributing to influential leadership on DM activities to support clinical development, regulatory submissions, and inspections.

• Responsible for all DM deliverables as the program lead in multi-disciplinary interactions
• Provides strong quality and project oversight over third party vendor
• Responsible for data management deliverables by closely monitor data quality, timeline and actively identify and mitigate risks
• Efficiently plans, coordinates, and delivers complete high quality and reliable clinical trial data
• Responsible for end-to-end clinical data management activities including integration requirements (Oversee the design, building, testing and maintenance of clinical study database as well as oversight of data finalization and database lock activities)
• Represent Data Management on cross-functional project teams and submission teams.
• Serve as in house DM point of contact at program level, in all interactions with vendors, provide review and approval for both DM functional documents and other relevant study documents as needed.

Provides oversight vendor DM work to ensure high quality

Participates to best practices initiatives, identify the need, and participates to the creation of functional standard operating procedures and Work Instructions for DM function

Qualifications

• Master’s Degree preferred or bachelor’s degree with extensive years of DM work experience in the pharmaceutical or biotechnology industry required
• 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

• 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.

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.