- Provide strategic direction for outsourcing, selection, and oversight of CROs, and provide ongoing executive management to selected partners.
- Develop and continuously monitor study timelines, study progress, study costs, and resource allocations. Implement corrective action when deviations occur; work with functions to develop contingency plans and drive their implementation when triggered.
- Oversee the preparation and management of clinical trial budgets. Support Finance and Corporate Development to forecast estimated costs for potential studies. Liaison with Clinical and Finance teams to review CRO budgets, change orders, invoices, and to approve payments.
- Work with internal team members and CROs in the identification, evaluation and selection of clinical trial investigators and sites, including cooperative groups in multi-center trials as well as in investigator-initiated studies.
- Conduct CRO and vendor audits to ensure compliance with global regulatory requirements.
- Interact collaboratively with Quality, Regulatory, CMC, Finance, and Clinical teams to ensure operational excellence in clinical trial execution to ensure compliance with GCP and ICH guidelines and financial reporting requirements.
- Support development of SOPs and establishment of associated training for teams, and ensure consistency, quality and compliance with global clinical standards.
- Work with internal team members to ensure compliance with all domestic and foreign regulatory requirements governing the conduct of clinical trials of human subjects.
- Forecast resourcing requirements to meet the needs of current and projected study activities.
- BS (Science degree) with 10+ years, MS/RN with 8+ years
- Broad and deep knowledge of clinical operations, clinical development, and clinical project management
- Experience with CRO management
- Experience with clinical trial audit activities
- Expected competencies:
- Working knowledge of ICH/GCP guidelines
- Effective written/verbal communication
- Ability to work independently as well as collaboratively in a multidisciplinary setting
- Flexibility and willingness to adapt in a changing environment
- Ability to travel
- Travel may be required up to 25% of your time
- The successful candidate will be required to reside within a commutable distance of our South San Francisco office. ALX Oncology Inc. follows a hybrid work model (i.e., part-time in South San Francisco office with flexibility to work part-time remotely).
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Director, Clinical Operations - South San Francisco, United States - ALX Oncology Holdings Inc.
Description
ALX Oncology is a clinical-stage immuno-oncology company focused on helping patients fight cancer by developing therapies that block the CD47 checkpoint pathway.
Our lead candidate, ALX148, 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
The Associate Director or Director, Clinical Operations will guide the clinical team to achieve all milestones and deliverables from protocol creation to study completion.
The candidate will actively participate to develop and execute the clinical trial strategy in support of the Clinical Development Plan, and to work across departments to ensure that studies are planned and conducted efficiently and with the highest quality.
The candidate will manage cross-functional activities in order to ensure that clinical study goals are met on time and within budget.
Responsibilities:
These may include but are not limited to:
Requirements:
Salary:
$200,000-$240,000 DOE
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.
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