BioSpace
DIRECTOR/ SR. DIRECTOR CLINICAL OPERATIONS
BioSpace, Redwood City, California, United States, 94061
DIRECTOR/SR. DIRECTOR CLINICAL OPERATIONS
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. Job overview 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
Plan and execute clinical trials to achieve program deliverables within established timelines and budgets, with high quality Provide clinical operations leadership and day-to-day oversight for all study activities, including development of study protocols, informed consent forms, vendor/site selection, study plans, patient recruitment, monitoring, and data cleaning Oversee and manage external vendors Identify, assess, and manage/mitigate clinical study risks and challenges Identify and select clinical sites and potential clinical partners Act as issue escalation point for vendors on assigned clinical programs, including CROs May manage direct reports including performance management and development planning Contribute to planning and implementation of studies including enrollment forecasting and operational strategies Contribute to developing department processes to ensure adherence to Adicet standards and applicable regulations Develop and facilitate standard clinical trial management plans and GCP compliance activities, including inspection readiness Oversee site and sponsor GCP inspection preparation and support Oversee study budgets and approvals Ensure all work adheres to ICH GCP guidelines and company policies Qualifications
Bachelor’s or Master’s degree in life sciences or related field 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 Strong problem-solving and adaptability; experience in budget/timeline management Experience in cell therapy, oncology, or autoimmune diseases preferred Expertise in developing and managing clinical study budgets and timelines; experience in cell therapy preferred. Onsite requirements Adicet fosters a collaborative, high-performing environment and requires onsite presence at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence. Compensation and benefits Pay range: $220,000—$304,000 USD. Comprehensive benefits include base salary, annual bonus, equity, ESPP, 401(k) with Roth, health plans, FSA/HSA, life/AD&D, disability, and other voluntary programs. Generous paid time off, holidays, and parental leave are provided. Location Redwood City, CA. Adicet is located in a state-of-the-art facility with onsite gym, parking with EV charging, free shuttle, and onsite meals. EEO Statement Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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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. Job overview 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
Plan and execute clinical trials to achieve program deliverables within established timelines and budgets, with high quality Provide clinical operations leadership and day-to-day oversight for all study activities, including development of study protocols, informed consent forms, vendor/site selection, study plans, patient recruitment, monitoring, and data cleaning Oversee and manage external vendors Identify, assess, and manage/mitigate clinical study risks and challenges Identify and select clinical sites and potential clinical partners Act as issue escalation point for vendors on assigned clinical programs, including CROs May manage direct reports including performance management and development planning Contribute to planning and implementation of studies including enrollment forecasting and operational strategies Contribute to developing department processes to ensure adherence to Adicet standards and applicable regulations Develop and facilitate standard clinical trial management plans and GCP compliance activities, including inspection readiness Oversee site and sponsor GCP inspection preparation and support Oversee study budgets and approvals Ensure all work adheres to ICH GCP guidelines and company policies Qualifications
Bachelor’s or Master’s degree in life sciences or related field 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 Strong problem-solving and adaptability; experience in budget/timeline management Experience in cell therapy, oncology, or autoimmune diseases preferred Expertise in developing and managing clinical study budgets and timelines; experience in cell therapy preferred. Onsite requirements Adicet fosters a collaborative, high-performing environment and requires onsite presence at least three days per week (Tuesday–Thursday mandatory), with some roles requiring full-time onsite presence. Compensation and benefits Pay range: $220,000—$304,000 USD. Comprehensive benefits include base salary, annual bonus, equity, ESPP, 401(k) with Roth, health plans, FSA/HSA, life/AD&D, disability, and other voluntary programs. Generous paid time off, holidays, and parental leave are provided. Location Redwood City, CA. Adicet is located in a state-of-the-art facility with onsite gym, parking with EV charging, free shuttle, and onsite meals. EEO Statement Adicet is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
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