Head of Clinical Operations
Clinical Development | South San Francisco, CA | Full Time
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™) therapies for cancer. Led by a world-class management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell therapy 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 Twitter and LinkedIn.
Allogene is seeking at highly motivated and passionate Head of 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 Head 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 be based in South San Francisco, CA and reports to the Chief Medical Officer.
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, 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
- 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
- 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, 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
- 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.
As an equal opportunity employer, Allogene Inc. 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact the careers email at www.allogene.com for assistance.
For more information about equal employment opportunity protections, please view the ‘EEO is the Law’ poster.