Associate Director, Clinical Operations

About Allogene:

Allogene Therapeutics with headquarters in South San Francisco is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy Allogene is developing a pipeline of off-the-shelf CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand more reliably and at greater scale to more patients. For more information please visit and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.

About the role:

Allogene is seeking an Associate Director Clinical Operations to oversee the successful completion management of all clinical trials and related clinical trial milestones within established timelines and budgets. The ideal candidate for this role is an individual who is excited to take on new challenges in a fast-paced and dynamic start-up environment. This individual will manage the development of study protocols oversee and manage CROs manage clinical study start-up and execution including site and vendor selection development of study plans EC/IRB submissions DMC charters patient recruitment clinical study monitoring clinical compliance/SOPs safety evaluations preparation of statistical analysis plans and clinical study reports data management and vendor management.

Responsibilities include but are not limited to:

• Responsible for strategically planning and managing clinical trials resourcing and providing oversight of vendors/execution to achieve program objectives and high-quality deliverables within established timelines and budgets
• Implement processes and successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives
• Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards policies systems and processes across all trials
• Effectively identify and oversee the management of external vendors to provide high-quality deliverables within established timelines and budgets
• Work collaboratively and communicate effectively with all functional area representatives within and with senior management in the project team environment and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals
• Develop and implement resource management and trial metric tracking tools and establish performance goals by role. Develop and maintain systems for effectively managing service provider relationships
• Ensure Clinical Operations is compliant with company policies and procedures as well as other applicable rules guidelines and codes of practice required by regulators or law
• Mentor junior team members to help assure their ongoing career development
• Other duties as assigned

Position Requirements & Experience:

• BA/BS required advanced degree with scientific or health-care training preferred
• 10 years professional pharmaceutical development Clinical Operations experience with a minimum of 5 years leadership clinical trial management experience
• Cell therapy industry experience with expertise in the areas of ex-US clinical operations development and strategic planning is required
• Experience with early to late-stage clinical trials and with the IND to BLA process
• Able to manage clinical operations for a product from pre-clinical through all clinical phases and product launch
• Demonstrate leadership in a clinical operations role
• Previous experience as a people manager and/or mentor
• Willingness and ability to travel domestically and internationally as required
• Candidates must be authorized to work in the U.S.

We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package which includes an annual performance bonus equity health insurance generous time off (including 2 annual holiday company-wide shutdowns) and much more. The expected salary range for this role is $170000 to $215000. Actual pay will be determined based on experience qualifications geographic location business needs and other job-related factors permitted by law.

As an equal opportunity employer Allogene is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race color religion national origin gender age sexual orientation physical or mental disability genetic information or characteristic gender identity and expression veteran status or other non-job-related characteristics or other prohibited grounds specified in applicable federal state and local laws. We also embrace differences in experience and background and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.

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