Medical Director, Clinical Development (Oncology)

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.

Requirements & Experience

• 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
• 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
• Communicate with internal and external physicians to evaluate specific safety events

Benefits

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) and much more. The expected salary range for this role is $255,000 to $335,000 per year. Actual pay will be determined based on experience, qualifications, geographic location, business needs, and other job-related factors permitted by law.