ALX Oncology Inc. is a publicly-traded, clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept (ALX148), is a next-generation CD47-blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. ALX is headquartered in South San Francisco, California.

We are seeking an exceptionally talented individual for the Clinical Trial Manager / Senior Clinical Trial Manager position. This role will be responsible for providing operational support for studies conducted by the ALX Oncology team, and work in partnership with internal colleagues, external partners, and clients to ensure delivery to time, quality, and cost expectations.

Key Responsibilities

Contributes to the identification and selection of appropriate CROs and third-party study vendors, and ensures appropriate cross-functional input is included in the scope of work.
Oversees performance of CROs, 3rd party vendors to ensure compliance with study protocol and in accordance with scope of work, escalating as needed.
Ensures Study Team members and 3rd party vendor training on protocols and study documents.
Contributes to the development of clinical protocols, amendments, informed consent forms, study guides, lab manuals, case report forms, study plans and any other clinical research related documents, in collaboration with cross-functional team members or CRO partners.
Establishes and maintains good working relationships with investigators and study staff.
Ensures studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
Manages study timelines, including study team goal and milestone creation, and monitoring progress.
Analyzes the feasibility data received from the CRO and makes recommendations for the strategic country and site distribution and patient numbers.
Collaborates with Vendor Management in creating and managing study finances, including but not limited to, budget creation, negotiation and maintenance, invoice and payment management.
Collaborates with Data Management to oversee data quality issues (query and data quality management and resolution).
Reviews key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determines appropriate action in conjunction with study team.
Performs TMF maintenance checks and oversees CRO TMF management.
Travel: Up to 25%.

Qualifications

BS/BA in a relevant scientific discipline is preferred.
Minimum 2-5 years clinical trial management experience in the pharmaceutical industry or equivalent; oncology experience is highly desirable.

ALX Oncology is an equal opportunity employer. All applicants should be legally entitled to work for any employer in the US. Title and salary are commensurate with experience.

To apply for this position, please send your cover letter and resume to hr@alxoncology.com.