Director, Clinical Operations
Clinical | South San Francisco, CA | Full Time
Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.
Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium which includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.
Description and Responsibilities:
Allogene is seeking a Director of Clinical Operations to oversee the successful completion 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, clinical study execution, 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.
- Responsible for strategically planning clinical trials, resourcing, and providing oversight/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 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.
- BA/BS required, advanced degree with scientific or health-care training preferred and minimum of 10 years professional pharmaceutical development experience, with a minimum of 8 years leadership 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.
- 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 Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance. For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.