Associate Director/ Director, Clinical Operations
Clinical Operations | Remote in South San Francisco, CA | Full Time
About Allogene Therapeutics, Inc:
Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.
At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
About the role:
Allogene is seeking an Associate Director/ Director of 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 contribute in 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 and minimum of 10 years professional pharmaceutical development Clinical Operations experience, with a minimum of 8 5 years leadership clinical trial management experience
- Experienced in industry with expertise in the areas of clinical operations development and strategic planning; experienced 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
- Demonstrated leadership in a clinical operations role
- Previous experience as a people manager and/or mentor
- Willingness and ability to travel domestically and international as required
- Candidates must be authorized to work in the U.S.
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.
Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.