Senior Director, Clinical Studies
Clinical Development | South San Francisco, CA | Full Time
Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.
Reporting directly to the Head of Clinical Development, the Senior Director, Clinical Studies will oversee the strategy and execution of clinical trials for allogeneic CAR T cell products in Oncology. The Senior 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.