About Allogene:
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™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of “off-the-shelf” CAR T cell product 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 X (formerly Twitter) and LinkedIn.
About the role:
The Senior Clinical Trial Manager (Sr. CTM) is responsible for management of clinical trials from study start-up activities through the clinical study report. A 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.
Responsibilities may include, but are not limited to:
- Manage 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.).
- Interface with cross-functional teams as Clinical Operations regional or global study lead (e.g., Medical Monitor, Regulatory Affairs, Safety, CMC, Supply Chain, CQA, CRO, vendors and Investigators/site staff). Work cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
- May lead cross functional study management team or oversee clinical trial execution in one or more regions within a global clinical trial.
- Use operational and therapeutic expertise to optimize trial design and execution; identify process improvements within and across clinical studies.
- Contribute to protocol and amendment development, Informed Consent Forms, clinical trial-related training, and Site Study Tools
- Ensure clinical trial execution in compliance with the protocol and ICH/GCP guidelines/regulations, including the review of monitoring reports, protocol deviations, and eTMF
- Partner with Clinical Quality Assurance in the planning of quality assurance activities and coordinate resolution of audit findings including initiation and follow through on corrective and preventative actions (CAPA)
- Vendor selection and set up (including scope of work development and review), may include Clinical Research Organization (CRO), central lab, imaging, and specialty labs.
- Vendor oversight: effectively communicate expectations to CRO/vendor, ensure appropriate site management, hold CRO/vendor accountable to timelines, and verify quality metrics
- Provide study-specific training and leadership to clinical research staff, including CRO, CRAs, sites and other contract personnel.
- Manage study budget; review and approve clinical invoices against approved scope of work and budget, evaluate and approve vendor change orders, coordinating review of updates or revisions with key cross-functional partners, as necessary.
- Prepare and present project debriefings to Clinical Operations management.
- Provide study-related guidance and leadership to internal and external partners, as appropriate.
- Other duties as assigned.
Position Requirements & Experience:
- Bachelor's degree or equivalent combination of education/experience in science or health-related field with at least 6 years of clinical trial management experience in a Pharmaceutical/Biotech organization.
- Clinical trial management experience as a contractor or employee of an industry sponsor
- Vendor management
- Oncology experience, with T-cell immunotherapy experience strongly preferred.
- Multi-regional study management experience advantageous (Australia, Europe)
- 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.
- Pro-active approach; able to identify when deliverables are off-track and propose/implement solutions early
- Candidates must be authorized to work in the U.S.
We offer a chance to work with talented people in a collaborative environment. 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.
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Last updated on Oct 21, 2024