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 at highly motivated and passionate VP, Clinical Operations to join our team. 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. The VP of Clinical Operations will mentor and manage the clinical operations staff, providing oversight of operations, ensuring strategic program planning and successful execution of all clinical studies with the highest level of data quality and compliance to quality standards and regulatory guidance, and within approved budgets. This position will report to the EVP, Head of R&D.

Responsibilities include, but are not limited to:

• In partnership with cross-functional leaders, co-ordinate and align the global strategy, study design, and execution of clinical trials in accordance with the strategic development plan and organizational timelines.
• Oversee global trial conduct and ensure consistency across programs, studies, functions, and regions in study planning, start-up, and execution.
• Ensure optimal workforce planning, training, retention, and performance management including but not limited to study management, quality assurance, drug supply and logistics, and clinical contracts and financing
• Lead a high-performing team to successfully conduct studies in accordance with appropriate. quality standards including ICH/GCP and applicable FDA/global regulations
• 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, clinical study execution, EC/IRB submissions, DMC charters, patient recruitment, clinical study monitoring, clinical compliance/SOPs, safety evaluations, preparation of statistical analysis plans and clinical study reports, data management, and vendor management
• Oversee the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical sciences
• 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 within senior management, in the project team environment, and with external stakeholders as needed to ensure alignment across functions to support clinical programs and corporate goals
• Oversee the clinical operations aspects of cross functional work processes involving medical writing, legal, finance, quality assurance, pharmacovigilance, biometrics, program management, regulatory, pharmaceutical sciences, IT, medical affairs, translational science and clinical sciences.
• Develop and implement resource management and trial metric tracking tools and establish performance goals by role
• Develop and maintain systems for effectively managing service provider relationships
• 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, 6 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
• 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
• Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably 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
• Ability to travel (10% depending on project needs)
• 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) and much more. The expected salary range for this role is $320,000 to $380,000. 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.

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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