Senior Clinical Trials Manager

at  Bicycle Therapeutics

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, Massachusetts US.

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 Senior Clinical Trials Manager will support the team in the planning, implementation, and oversight of Bicycle’s clinical trials to ensure it is conducted in accordance with study plans. They will execute on decisions and strategies for achieving clinical program objectives, and partner with matrixed functions such as clinical sciences, translational sciences, medical, program management, and finance. They will also interact frequently with external parties, such as study sites, vendors, investigators, and advisors.

KEY RESPONSIBILITIES

• Leads clinical trials under a distinct program by demonstrating a high level of knowledge of organizational, project management and clinical trial leadership capabilities
• Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters. Oversees the day-to-day supervision of clinical trial execution, with a focus on site start up, patient enrollment, monitoring, compliance, and data flow metrics from the clinical sites, CROs and central labs.
• Works cross functionally to develops and manage clinical program risk and opportunity mitigation plans to ensure delivery to timelines, budget and quality with efficient resource utilization.
• Independently manages and supervises clinical trial vendors and partners such as CROs, central labs, biomarker and specialty laboratories, and clinical trial sites.
• Leads CRO and other vendor selection and reviews contracts/work orders/change orders
• Ensures inspection readiness for clinical trials including oversight of the trial TMF
• Reviews metrics and Key Performance Indicators to ensure oversight of clinical trial progress.
• Manages clinical trial budgets and execution of trial timelines.
• Leads investigator meetings, kick-off meetings, monitoring training, and various CRO (or other vendor) meetings.
• Reviews protocol deviations and evaluate trends within studies. Approves of action plans to address protocol compliance, safety, data and administrative issues with investigational sites and CROs.
• Reviews monitoring visit reports, ensure study issues and action items are addressed, escalated and closed out appropriately and in compliance with study plans.
• Attends site visits to ensure oversight of CRO and clinical trial sites.
• Participates in the development of study documents/deliverables including but not limited to clinical trial protocols, amendments, informed consent forms, CRFs, IRB/Ethics applications, study guidelines, operations manuals, training materials and recruitment materials.
• Contributes to the clinical content to program deliverables such as Investigator’s Brochure (IB), Development Safety Update Report (DSUR), etc.
• Presents trial status and clinical operations trial execution strategy to project team and management.
• Interacts and establishes relationships with clinical trial investigators and key opinion leaders.
• Provides mentoring to junior team members and/or management and development of direct reports, as required.
• 
  Qualifications
  The applicant will have previous experience working in clinical operations, having contributed clinical trial study site activation, execution, and close out, primarily with oversight of a CRO. The successful candidate will be well-versed in the host of activities that underpin a clinical study, and actively communicate status, obstacles, and issue resolution to the program team.

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