Senior Clinical Trial Manager
Clinical Development | South San Francisco, CA | Full Time
Allogene Therapeutics is a biotechnology company with a mission to catalyze the next revolution in cancer treatment through the development of allogeneic chimeric antigen receptor T-cell (CAR T) therapy directed at blood cancers and solid tumors. Founded and led by former Kite Pharma executives who bring unrivaled clinical development acumen in cell therapy, Allogene is well-positioned to further the potential of allogeneic cell therapy for patients.
Allogeneic CAR T therapies are engineered from cells of healthy donors and stored for “off-the-shelf” use in patients. This approach eliminates the need to create personalized therapy from a patient’s own cells, simplifies manufacturing, and reduces the time patients must wait for CAR T treatment. The Allogene portfolio includes 16 pre-clinical T cell therapy assets and UCART19, an allogeneic CAR T therapy currently in Phase 1 development for the treatment of acute lymphoblastic leukemia (ALL). Through its notable partnerships, Allogene leverages pioneering technology platforms, including TALEN® gene editing technology, to progress its portfolio of immuno-oncology therapies. Allogene, with headquarters in San Francisco, California, is a Two River portfolio company formed with one of the largest Series A financings in biotechnology from an investment consortium which includes TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer. For more information, please visit www.allogene.com, follow @AllogeneTx on Twitter and LinkedIn.
Description & Responsibilities:
The Senior Clinical Trial Manager (Sr. CTM) is responsible for the management of clinical trials from study start-up activities through the clinical study report. The Sr. CTM drives completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance; proactively identifies, communicates and resolves clinical study operational issues; and participates in process improvement initiatives as required.
- Manages all clinical aspects of study under oversight of Clinical Operations senior management including: initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.).
- Ensures clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations: participates in the planning of quality assurance activities and coordinates resolution of audit findings; ensures audit-ready condition of clinical trial documentation; reviews monitoring reports to ensure quality and resolution of site-related issues. Includes interfacing with QA for CAPA documentation and resolution.
- Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
- Leads selection activities for external vendors and is responsible for the management/oversight of external vendors including: the development vendor specifications; review vendor reports, budgets, and metrics;
- Provides study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel
- Works with Clinical Operations senior management and finance to manage the study budget. And ensures it aligns with department financial goals; reviews and approves clinical invoices against approved budget. Coordinates review of updates or revisions with key cross-functional partners, as necessary.
- Conducts the internal review of investigator contracts and payments, as necessary.
- Prepares and presents project debriefings to Clinical Operations management.
- Uses operational and therapeutic expertise to optimize trial design and execution, and works with the study team to strategize on clinical trial execution.
- Works with the CRO to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff.
- Interfaces with cross-functional teams as Clinical Operations study lead (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Works cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
- Provides study-related guidance and leadership to internal and external partners, as appropriate.
- Bachelor's degree or equivalent combination of education/experience in science or health-related field.
- Minimum of 7 years of clinical trial management experience in a Pharmaceutical/Biotech organization.
- Global, registrational study experience.
- Oncology experience, with T-cell immunotherapy experience strongly preferred.
- Robust understanding of ICH/GCP, and knowledge of regulatory requirements.
- Strong clinical study/project management skills.
- Excellent communication and organizational skills (ability to prioritize a number of tasks of varying complexity), along with problem solving, conflict resolution, leadership and team-building skills.
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 careersatallogenedotcom for assistance.