Job 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 Cambridge, MA.Culture is key and all Bicycle employees actively embrace and role model our company values:WeareAdventurous.We believe it'sthewaytodeliverextraordinaryresultsforourpatients.WeareDedicatedtoourMission.Youcan'tchangetheworldifyoudon'thavedetermination.WeareOneTeam.Weonlysucceedwhenweworktogether.Job DescriptionThe 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. Theywill 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.Leads clinical trials under a distinct program by demonstrating a high level of knowledge of organizational, project management and clinical trial leadership capabilitiesEnsures 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 dependently 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 contractswork orderschange ordersEnsures inspection readiness for clinical trials including oversight of the trial TMFReviews 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 documentsdeliverables including but not limited to clinical trial protocols, amendments, informed consent forms, CRFs, IRBEthics 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 teracts and establishes relationships with clinical trial investigators and key opinion leaders.Provides mentoring to junior team members andor management and development of direct reports, as required.QualificationsThe 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.Bachelor's degree in scientific, biological, life sciences, or related field.Clinical trial management 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 environmentExcellent working knowledge of Good Clinical Practices, ICH guidelinesExcellent 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 environmentDesirable:Experience in managing oncology studiesExperience in managing early phase (1 and 2) studiesAdditional InformationFlexible working environmentCompetitive reward including annual company bonusMedical, dental, and vision insurance for eligible employees and their families with 100% of the premiums covered by the CompanyHealth and Dependent Care Flexible Spending Accounts401(k) plan with a 4% Company match and immediate vestingEligibility to accrue up to 23 paid time off days per full year worked, plus the option to buy up to 5 additional daysEmployee assistance programEmployee recognition schemes10 Company holidaysCompetitive Family Leave PolicyEligibility 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.