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 South 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.
Allogene is seeking a Clinical Lead for an allogeneic CAR T cell therapy. 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. Reporting to the Head of Clinical Development, this individual will have oversight of and accountability for all clinical studies from IND submission to post-marketing commitment (PMC) studies and ISTs for a product candidate.
Responsibilities include, but are not limited to:
- Define and shape the clinical development strategy and overall business strategy for a product candidate
- Contribute to the design, start-up, execution, analysis and communication of the clinical studies for a product candidate
- Form and enhance working relationships with external clinical research collaborative groups to support a product candidate
- Define clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications.
- Support 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 clinical activities.
- Other duties as assigned.
- MD with demonstrated depth and breadth of knowledge and experience in clinical research in academic or industry setting.
- Board certification in Oncology is desirable.
- At least 5 years of experience in the pharmaceutical industry with a track record in 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.
- Experience in the development of immune-therapeutics in Oncology.
- Understanding of the related disciplines (eg, biostatistics, regulatory, pharmacology and toxicology research, clinical pharmacology and pharmaceutical sciences).
- 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.
- Demonstrated scientific productive (publication, abstracts, etc).
- 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.