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Senior Medical Director, Clinical Development
3 months ago
Job Description
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. For more information, please visit www.allogene.com, and follow @AllogeneTx on X (formerly Twitter) and LinkedIn.
About the role:
Allogene is seeking an experienced Rheumatologist to join us as a Medical Director / Senior Medical Director for our allogeneic CAR T cell therapy 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. Reporting to the Head of Clinical Development, this individual will have oversight of and accountability for clinical trials from study start-up to BLA approval. This is a key organizational position with high visibility to senior leadership. This position is based out of our headquarters in South San Francisco, CA or in Los Angeles, CA.
Responsibilities include, but are not limited to:
- Lead the cross-functional study team
- Define and shape the clinical development strategy and overall business strategy for a product
- 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 researchers to support a product candidate
- Lead and moderate advisory boards with key opinion leaders and investigators
- Define clinical study protocols; recommend new clinical trial sites and investigators; recommend specific data outputs and publications.
- Collaborate with Clinical Operations to expedite execution of clinical trials
- Support regulatory activities, medical affairs, and payer engagements; represent Allogene in external scientific and medical forums.
- Develop and effectively manage annual operating and budget plan for clinical study activities
- Other duties as assigned
- Medically trained Rheumatologist with demonstrated depth and breadth of knowledge and experience in clinical research in the industry setting
- 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 in the biopharmaceutical industry, ideally spanning global multinational and specialty biopharma organizations
- Experience in the development of cellular therapy is desired
- Understanding of the related disciplines (i.e. biostatistics, regulatory, pharmacology and toxicology research, cell therapy manufacturing, clinical pharmacology and pharmaceutical sciences)
- Must be able to collaborate and work with other departments such as ClinOps, Safety, Translational, Biometrics, Regulatory, Commercial, Finance, Manufacturing, and Supply Chain
- 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 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 production (publication, abstracts, etc.)
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment and provide a top-notch compensation and benefits package, which includes an annual performance bonus, equity, health insurance, generous time off (including 2 annual holiday company-wide shutdowns weeks) and much more. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.
As an equal opportunity employer, Allogene 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. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment and internships designed to create a stronger and better Allogene that is focused on developing life-changing products for patients.
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