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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.
DIRECTOR/SR. DIRECTOR CLINICAL OPERATIONS
The Director/Sr. Director Clinical Operations will provide operational leadership to ensure the successful planning, implementation, and oversight of assigned programs in the Adicet portfolio. The position requires strong organizational skills and the ability to work collaboratively in a fast-paced biotech environment.
Responsibilities:
- Responsible for planning and execution of clinical trials, to achieve program deliverables within established timelines, budgets and with high quality
- Provide clinical operations leadership and day-to-day oversight for all study activities including the development of study protocols, informed consent forms, vendors and site selection, preparation of study plans, patient recruitment, clinical study monitoring and data cleaning
- Effectively oversee and manage external vendors
- Lead the proactive identification, assessment, and management/mitigation of clinical study risks and challenges
- Lead identification and selection of clinical sites and potential clinical
- Serve as issue escalation point for vendors on assigned clinical programs, including clinical CROs
- May manage direct reports including performance management and professional development planning for team members
- Contribute to the planning and implementation of clinical studies including scenario planning, forecasting enrollment and timelines, and development of operational strategies.
- Contribute to developing department processes to ensure adherence to Adicet standards, and all applicable regulations and guidelines.
- Contribute and facilitate the development of standard clinical trial management plans and
- Contribute and facilitate Clinical Operations' GCP compliance activities, and inspection readiness
- Oversee clinical site and sponsor GCP inspection preparation and support
- Oversee study budget(s) and review/approve
- All work must adhere to ICH Good Clinical Practice (GCP) guidelines and comply with company
Qualifications:
- Bachelor's or Master's in life sciences or related field
- More than 10+ years of clinical operations experience managing global Phase 1-3 clinical trials
- Proven ability to lead a team
- Strong knowledge of global clinical development processes and regulatory guidelines
- Excellent communication, presentation, and negotiation skills to support a collaborative team environment
- Strong problem-solving skills and adaptability
Expertise in developing and managing clinical study budgets and timelines Experience in cell therapy, oncology or autoimmune diseases preferred
Adicet 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.