What are the responsibilities and job description for the Clinical Program Manager/Senior Clinical Program Manager position at ALX Oncology?
ALX Oncology is a clinical-stage and patient-focused immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway. Our lead candidate, evorpacept, is a next generation CD47 blocking therapeutic that combines a high-affinity CD47 binding domain with an inactivated proprietary Fc domain. For more information about us, please visit www.alxoncology.com.
The Clinical Program Manager/Senior Clinical Program Manager (CPM/Sr CPM) will provide operational expertise to one or more clinical programs, which will include one or more cross-functional clinical trial teams (phase 1-3 and Investigator Sponsored Trials). This individual will be responsible for the successful execution of program strategy as well as trials from the protocol concept through the clinical trial report, ensuring timely and efficient delivery of all program and study deliverables, in accordance with the appropriate quality standards including ICH/GCP and applicable regulations. The CPM/Sr. CPM will provide oversight of Clinical Research Organizations (CROs) and other third-party vendors. They will also work closely with cross-functional members of Study Management Teams.
This position will report to the Vice President of Clinical Operations.
Responsibilities:
These may include, but are not limited to:
- Provides operational expertise at the Project level for one or more programs, in conjunction with the head of Operations
- Leads and provides direction to Study Management Teams (SMT).
- Delegates and provides guidance/mentorship to Clinical Trial Managers and/or Clinical Program Associates.
- Identifies program risks, and proactively create sand implement mitigation strategies
- Leads 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
- Leads and oversees performance of CROs, 3rd party vendors to ensure compliance with study protocol and in accordance with scope of work, escalating as needed
- Contributes or leads 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
- Creates and manages program and study timelines, including study team goal and milestone creation, and monitoring progress
- Identify program risks, and proactively create and implement mitigation strategies
- Analyzes the feasibility data received from the CRO and makes decisions 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
- Develop relationships with key thought leaders to support product development and represent ALX Oncology externally in applicable scientific and medical forums
- Oversees CRO TMF management and maintenance checks
- Identify and develop best practices
- Domestic and/or international travel may be required up to 25%
Qualifications:
- BA/BS in a relevant scientific discipline or equivalent combination of education/experience in science or health-related field required
- Minimum 8 years clinical trial leadership experience (10 years preferred) in the pharmaceutical industry or equivalent; oncology experience is highly desirable
- Strong leadership and motivational skills developed through leading successful multi-functional matrix study teams through all stages of clinical studies
- Applies critical thinking and aims to simplify work.
- Experienced in developing and executing plans including but not limited to study goal, milestone and risk management plans.
- Must have experience creating and managing complex study budgets, with a focus on financial management of vendors
- Strong vendor management experience, from selection to management, and issue escalation. Experience developing scope of work, and ensuring adherence to it
- Strong understanding of GCP/ICH guidelines and the clinical development process
- Strong influencing, negotiation and conflict resolution skills to build relationships internally and externally at all levels of seniority, and achieve alignment and commitment to deliverables
- Self-motivated, critical thinker, and able to work with minimal oversight
- Detail oriented with the ability to work independently and manage multiple competing priorities under pressure
- Excellent oral and written communication skills and proficient computer skills
- Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).
- Must show proof of full COVID-19 vaccination to attend onsite at our South San Francisco office.
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. Our compensation program includes competitive salary, equity participation and attractive bonus incentives.