ALX Oncology is a clinical-stage and patient-focused immuno-oncology company developing therapies that block the CD47 myeloid 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. For more information about us, please visit www.alxoncology.com.
Reporting to the Head of Biometrics, we are seeking an exceptionally talented individual to provide data management expertise for the Company’s lead program, evorpacept. The Associate Director/Director, Clinical Data Management will work in an outsourced data management model, and manage and perform the end-to-end clinical data management activities for their assigned clinical program, while ensuring the highest level of data quality and compliance. This position will be an individual contributor role that will lead data management activities. This individual will interface with the project team to ensure that data management services are delivered in a consistent, high-quality manner, and will provide input into Biometrics strategy and implement department initiatives. This individual will also independently perform/oversee tasks related to database and report setup, as well as processing and cleaning clinical trial data, following all applicable standard and study-specific procedures.
Key Responsibilities and Success Factors:
Serve as a data management expert and be the CDM lead for assigned clinical studies on multidisciplinary project teams
Deliver high quality data for analysis and study milestones
Review protocols from a CDM perspective and provide functional-expert feedback
Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding, data listing specifications, and electronic data transfer agreements
Manage/oversee study setup, testing and system validation for new studies in partnership with the DM vendor
Oversee data cleaning activities executed by the CRO and ensures protocol-specified guidelines are applied to the review and cleaning of clinical data
Collaborate with internal Biostatistics, Medical Monitors and Clinical Operations on identifying critical variables in the clinical dataset, for protocol-specified endpoints. Coordinate implementing these variables into CRO DM activities.
Develop SOP for Data Management with collaboration with cross-functional team
Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and ALX project team
Monitor vendor performance to ensure timelines and data quality standards are met.
Ensure compliance of clinical data management processes with applicable regulations and guidelines
Help identify and support solutions to manage complex issues and escalate to senior management as appropriate
Perform work and process redesign to improve individual and team effectiveness
Ensure deadlines are met and inform key stakeholders of project/program status
Promote constructive, effective relations with and between team members.
Ability to work within a team as well as independently
Provide leadership and direction for department strategic initiatives
Work with Head of Biometrics, Senior Management and Human Resources to identify and justify resource needs, develop staffing plans, recruiting process within Biometrics
Education and Experience:
BA/BS or higher preferably in math, science or health-related field with a minimum of 10 years of experience in clinical data management across phase 1- 3 clinical trials. At least 6 years of the overall experience require acting as a study lead data manager
Experience in regulatory GCP inspections/audits is a plus
Comprehensive experience working with clinical database systems
Working knowledge of CDISC including CDASH, TAUG and SDTM as well as data privacy regulations e.g. GDPR
Successfully manage clinical data management vendors, contractors and service providers for program deliverables
Managerial and oversight experience with junior level data managers preferred
Experience in Oncology and/or Immuno-oncology trials preferred
Able to work in a fast paced and dynamic environment while effectively managing multiple projects which may have changing priorities
Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors
Excellent verbal and written communication skills and interpersonal skills
Strong analytical and problem-solving skills
Hybrid work model acceptable (i.e., part-time in South San Francisco office with flexibility to work part-time from home).
Salary:
Associate Director: $160,000-$190,000 DOE
Director: $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.