Clinical Lead, BCMA
Clinical Development | 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 Clinical Lead to contribute to the design, critical evaluation, and execution of the BCMA clinical development program. 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 have oversight of and accountability for all BCMA studies (incorporating registrational studies, PoC studies as well as the post-marketing requirement (PMR) and post-marketing commitment (PMC) studies, including ISTs).
- Define and shape the clinical development strategy and overall business strategy for BCMA.
- Contribute to the design, start-up, execution, analysis and communication of the clinical studies for BCMA
- Form and enhance working relationships with external clinical research collaborative groups to support BCMA.
- Define BCMA clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications.
- Support BCMA regulatory activities, medical affairs, and payer engagements; represent Allogene in external scientific and medical forums.
- Develop and effectively manage annual department operating and budget plan for BCMA clinical activities.
- PhD and/or MD in relevant field of biomedical research.
- Experience in clinical research across all phases of development, from first in human to pivotal, and to phase IV, in the biopharmaceutical industry, ideally spanning global multinational and specialty biopharma organizations.
- Must be able to collaborate and work with other departments such as Clinical, Commercial, Finance, Research & Development, Manufacturing, and Supply/Purchasing.
- Ability to work in a fast-paced, start-up environment.
- Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
- Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
- Ability to work independently and as part of a team.
- Strong interpersonal skills including verbal and written communication are essential in this collaborative work environment.
- 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 careersatallogenedotcom for assistance.