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About Allogene Therapeutics, Inc:

Allogene Therapeutics is a clinical-stage biotechnology company with a single-minded focus on pioneering the development of investigational allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer. Led by world-class management with significant experience in cell therapy, our fully integrated, in-house team of researchers is dedicated to discovery and translational research, development, and cell manufacturing.

At Allogene, we are developing a pipeline of off-the-shelf CAR T cell candidates, with the goal of delivering readily available cell therapy faster, more reliably, and at greater scale to more patients. For more information, please visit www.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

About the role:

Allogene is seeking a Senior Director of Clinical Operations to oversee management of clinical trials and related clinical trial milestones within established timelines and budgets. 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. This individual will manage and contribute in the development of study protocols, select, oversee and manage CROs and vendors, manage clinical study start-up and execution including site and vendor selection, development of study plans, EC/IRB submissions, DMC charters, patient recruitment, clinical study monitoring, clinical compliance/SOPs, assist with safety evaluations, collaborate with data management to achieve data base lock, review and support development of statistical analysis plans and clinical study reports. This position will report to the VP and Head of Clinical Operations.

Responsibilities include, but are not limited to:

• Responsible for strategically planning clinical trials, resourcing, and providing oversight/execution to achieve program objectives and high-quality deliverables within established timelines and budgets
• Implement processes and successfully plan and conduct multiple clinical trials in early to late stage to achieve corporate objectives
• Able to design and implement contingent plans to ensure the successful completion of trials
• Responsible for ensuring operational excellence in our clinical stage programs by applying high industry standards, policies, systems, and processes across all trials
• Provide clinical operations leadership and oversight for all study activities including the development of study protocols and informed consent forms, vendor and site selection, preparation of study plans, oversight of vendors, patient recruitment, clinical study monitoring and data cleaning, clinical study execution, DMC charters, clinical compliance/SOPs, safety evaluation and development and review of clinical study reports.
• Effectively identify and oversee the management of external vendors to provide high-quality deliverables within established timelines and budgets
• Work collaboratively and communicate effectively with all functional area representatives in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals
• Lead the proactive identification, assessment, and management/mitigation of clinical study risks and challenges
• Ensure Clinical Operations is compliant with company policies and procedures, as well as other applicable rules, guidelines and codes of practice required by regulators or law
• Other duties as assigned

Position Requirements & Experience:

• A minimum of a Bachelor's degree in a scientific or health related field is required
• 15 years of related Clinical Operations experience, 4 years in a leadership role
• Previous experience overseeing and completing complex global Oncology clinical studies, Immuno-Oncology, T-Cell immunotherapy experience and hematologic oncology is desirable
• Expertise in the areas of global drug development, planning, management and execution of clinical trial operations
• Experience successfully managing Phase I and Registrational clinical studies
• Proven strong clinical trial management skills (study start up through closure) with focus on executing to meet deliverables and timelines
• Robust knowledge of ICH, GCP guidelines, and other applicable regulations and practices
• Effective in promoting and maintaining productive internal and external relationships including investigators, site staff and CRO partnerships.
• Proven history of effectively selecting and managing CROs, including the establishment of governance bodies
• Proven leadership and team building skills, along with success in proactive risk mitigation and problem solving.
• Flexible and creative to meet the needs of a growing, dynamic company

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.

Please be aware that the FBI recently issued a warning about an increased number of fake job postings for remote work employment that target applicants' personally identifiable information. All approved Allogene Therapeutics positions are accessible via the Allogene Careers page at www.allogene.com/careers.

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