Director, Clinical Studies
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.
Reporting directly to the Clinical Lead, the Director, Clinical Studies will oversee the strategy and execution of clinical trials for allogeneic CAR T cell products in Oncology. The Director, Clinical Studies works with the members of the development team (including a medically qualified individual) to establish clinical development plan(s) for one or more CART products from lead development in discovery to registration, and for designing/executing and reporting protocols for studies included in the development plan.
Responsibilities include, but are not limited to:
- Contribute or primarily responsible for protocol/amendment design and authoring from FIH to registrational studies
- Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials
- Conduct data review, analysis and interpretation
- Perform and document regular study data reviews and other review activities.
- Author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR, BLA) as well as prepare strategy presentations, present and discuss data with governance, external consultants, KOLs and potentially within regulatory meetings in conjunction with members of the development team
- Interface with discovery, statistics, translational medicine, safety sciences, regulatory, clinical operations, clinical supplies, health economics and outcomes research, business, internal governance, external experts and regulators.
- Create and/or review study documents/plans (monitoring plan, data management plan, safety review plan, etc.)
- Proactively identify clinical development risks and propose risk mitigations
- Participate in the selection of sites, CRO, and vendors
- Travel (approximately 5-10% of the time) for study team meetings and to clinical sites for co-monitoring may be required
- Other duties as assigned
Position Requirements & Experience:
- Advanced scientific degree in Life Sciences preferred (PhD, PharmD, MA)
- Demonstrated experience in oncology drug development (early and late stage)
- 10+ years in clinical development in the biotechnology or pharmaceutical industries
- Experience with and understanding of relevant ICH guidance (e.g., E6 R2) and CFRs
- Ability to author and manage team review of clinical documents, such as protocols, protocol amendments, IB and informed consent forms
- Proven track record showing excellent clinical project management skills
- Broad understanding of clinical operations in relation to clinical development functions
- Detailed understanding of all aspects of clinical protocol design and implementation & overall drug development
- Ability to effectively interface with medical personnel at clinical site(s)
- Ability to lead multi-disciplinary teams both internally & externally
- Must have demonstrated problem solving abilities and strong organizational skills
- Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
- 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 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.