Associate Director / 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 www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
Allogene is seeking an Associate Director / 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 $170,000 to $235,000. 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.
#LI-EL1 #LI-REMOTE
About the job
Apply for this position
Associate Director / 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 www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
Allogene is seeking an Associate Director / 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 $170,000 to $235,000. 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.
#LI-EL1 #LI-REMOTE