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 they are conducted in accordance with study plans. They will execute 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 develop 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 evaluates trends within studies. Approves action plans to address protocol compliance, safety, data, and administrative issues with investigational sites and CROs.
* Reviews monitoring visit reports, ensures 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 of program deliverables such as the 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 to 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.
Essential:
* Bachelor’s degree in scientific, biological, life sciences, or related field.
* Extensive clinical trial management experience.
* Oncology experience.
* Experience overseeing CROs and other vendor partners.
* Excellent organizational, analytical, planning, and project management skills.
* Demonstrated excellent communication skills (both oral and written).
* Ability to contribute and manage in a cross-functional environment.
* Excellent working knowledge of Good Clinical Practices, ICH guidelines.
* Excellent management and leadership skills.
* Ability to independently manage multiple studies.
* Ability to communicate, verbal, analytical and organizational skills, project management, management, and computer expertise.
* Possess a strong commitment to quality and accuracy.
* A self-starter and a team player who thrives in a fast-paced environment.
Additional Information
* State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
* Flexible working environment.
* Competitive reward including annual company bonus.
* Employee recognition schemes.
* 28 days annual leave in addition to bank holidays + option to buy up to 5 additional days annually.
* Employer contribution to pension (employee does not have to contribute).
* Life assurance cover 4x basic salary.
* Private Medical Insurance, including optical and dental cover.
* Group income protection.
* Employee assistance program.
* Health Cash Plan.
* Access to company subsidized gym membership.
* Eligibility for an option grant to subscribe to shares in Bicycle Therapeutics plc.
* Cycle to work scheme.
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.
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