Medical Director, Clinical Development (Oncology)

Allogene Therapeutics•South San Francisco, CA

1d•$255,000 - $335,000•Hybrid

About The Position

About Allogene: 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) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. About the role: The Medical Director will lead the execution of an oncology clinical program with activities and accountability spanning medical leadership/monitoring of an active trial as well as developing and driving the clinical development strategy in alignment with the overall portfolio strategy of Allogene. This role is based out of Allogene’s headquarters in South San Francisco, CA. Remote candidates will be evaluated based on suitability for the position along with frequent to travel to Allogene’s South San Francisco or Los Angeles office.

Requirements

Medical Degree, residency and fellowship completed in oncology with at least 5 years of relevant post graduate experience in the biotech, pharmaceutical, academic and/or medical research environment (industry experience preferred)
Experience in hematology or oncology required (experience in cell therapy highly preferred)
Demonstrate a dedication to the mission of Allogene: to work hard to deliver life-saving new medicines for patients with cancer
Exemplify a positive, can-do attitude and work independently, often across functional lines, to move the program forward to achieve defined milestones
Comfortable with ambitious program timelines and working within a culture of personal and team accountability
Ability to evaluate and manage CROs and other vendors within budgets
Strong understanding of all the elements of oncology drug development pre-clinical and clinical programs and experience in their design and execution
Experience in review, filing and defense of IND's, CTA's and full dossiers
Experience in GXP (especially GCP, GLP) and experience working in a regulated environment dealing with Regulatory Inspection Readiness
Excellent organizational skills and an ability to prioritize effectively to deliver results within aggressive timelines with the 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
Ability to communicate with internal and external physicians to evaluate specific safety events
Candidates must be authorized to work in the U.S

Responsibilities

Medical monitoring and study leadership role of one or more clinical trial in oncology that may range from pre-IND through late development and registration
Seamless, productive integration into a multidisciplinary team across all departments involved in the design, execution, analysis and reporting of clinical trials
Facility with the subject matter of clinical development-adjacent functions including clinical operations, translational science, regulatory affairs, drug safety, biostatistics
Collaborate with functional leaders to set strategy and shared objectives and interactions with health agencies and vendors (including CROs)
Act as a point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
Define clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications
Apply scientific knowledge, clinical knowledge and extensive drug development experience to ensure the research and development strategies can address critical patient needs by improving the current standard of care for target oncology indications
Contribute to the design, start-up, execution, analysis and communication of the clinical studies for a product candidate
Interface with internal and external scientists, clinicians and stakeholders to assure the swift identification of new development opportunities and to continuously optimize and refine the development strategy
Establish cross-functional relationships with leaders from key cross-functional lines including Regulatory Affairs, Clinical Operations, Commercial, Program Management, etc. and leverage those relationships to manage key project issues including but not limited to Research, Development, Commercial, Manufacturing and Competitive Intelligence
Contribute relevant trial information to pipeline and prioritization analyses
Ensure that projects are managed appropriately per budget and that the necessary resources are available to the projects to support their success
Represent Allogene at meetings with regulatory authorities and third parties such as licensing or co-development partners, consultants, etc.
Other duties as assigned