Adicet Bio, Inc
JOIN US!Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of "off-the-shelf" gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.CLINICAL TRIAL MANAGERAs a key member of the clinical operations team, this position will support all aspects of Adicet Bio's clinical trials, including site activation, patient recruitment, study monitoring, site and CRO/vendor management. The successful candidate will have experience managing oncology clinical trials and a good knowledge of clinical operations, ICH/GCP and FDA regulatory requirements and will work cross functionally within the Adicet Bio team as well as with study sites, CROs and other vendors.Key responsibilities:Ensure clinical trial activities and deliverables are completed on-time, within budget, and in a complex environment in accordance with quality and GCP standards with minimal oversightLead the identification, evaluation, selection, and oversight of clinical trial sites, vendors and CROsWork closely with the Clinical Operations team to support all aspects of clinical studiesManage multiple clinical study vendors with oversight of activities.Plan and conduct Investigator's meetingsTake a leadership role in certain site and study management activities including: ICFs, site activations, monitoring reports and study plansCollaborate with cross functional team members to independently address routine study issuesAssist with CRO and/or vendor oversight and management to ensure milestones are achievedIdentify issues for escalation, participate in problem solving and implementation of risk mitigationParticipate in departmental and corporate initiativesPerform co-monitoring visits with CRO, on an as needed basis, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visitsEnsuring data entry is up to date and site queries are resolved in a timely mannerAssist with department compliance initiatives and SOP writingGenerate and maintain reports, study trackers, internal and external presentations and study documents as neededEnsure close tracking of site enrollment and related metricsEstablish and manage clinical trial master files (TMF).Complete other responsibilities as assignedQualifications:BS or higher degree in science, nursing (RN or BSN), or equivalent disciplineA minimum of 6 years of clinical research experience in biotechnology, pharmaceutical, or CRO industryExperience supporting studies in a fast-paced environmentSuccess in working with CROs and vendorsExcellent communication skills and ability to achieve milestones in a team environmentStrong working knowledge of FDA, ICH Guidelines, and GCPs governing the conduct of clinical trialsProficiency with Microsoft Word, Excel, PowerPoint and Project Adicet Bio requires all workers to be fully vaccinated against COVID-19, including the booster dose.Pay Range$161,000-$223,000 USDAdicet fosters a collaborative, high-performing environment by prioritizing in-person engagement. To enhance teamwork and communication, employees are required to be onsite at least three days per week (Tuesday-Thursday mandatory), with some roles requiring full-time onsite presence.At Adicet, our people are our greatest focus. We believe that attracting and retaining the best and brightest is the key to achieving our mission to deliver best-in-class gamma delta T cell therapies for patients fighting autoimmune diseases and cancer. We offer a competitive compensation package including base salary, annual cash bonus, long-term incentives (equity), Employee Stock Purchase Plan (ESPP) and a 401(k) with ROTH and a 4.5% Company match. To ensure the wellness of our employees and their loved ones, we offer comprehensive health plans (medical, dental, vision, etc.), Flexible Health and Commuter Spending Accounts (FSA) and a company matched Health Savings Account (HSA). We also offer a life, AD&D, short and long-term disability insurance, and legal, pet, and various other voluntary insurance programs. We also believe our greatest ideas come when we are refreshed and focused, and we offer generous paid time-off including 13 company holidays, paid end-of-year winter break, vacation, sick time, and paid parental leave. Adicet is located in a state-of-the-art facility and works to create an incredible office experience with an onsite gym and various other fitness options, onsite parking with electric vehicle charging stations and free shuttle (Caltrain), company-subsidized lunches (delivered onsite daily) and fully stocked breakrooms. Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.