Associate Director, Clinical Data Management

(Job: 2023-BN-08)

Ambrx Biopharma, Inc. (NASDAQ: AMAM) is a clinical-stage biologics company focused on discovering and developing a novel class of specific and selective engineered precision biologics, using our proprietary platform technology that allows site-specific incorporation of synthetic amino acids (SAAs) into proteins within living cells. Our product candidates are designed to overcome the inherent limitations of conventional conjugation approaches that use non-site-specific conjugation, in order to optimize for safety and efficacy benefits across multiple therapeutic classes in broad therapeutic areas.

SUMMARY: 

Ambrx is seeking a highly dedicated Associate Director to collaborate with cross-functional teams (including medical, clinical science, biostatistics, PK, and biomarker analysts) to ensure complete and quality clinical data collection for oncology clinical trials. Oversees activities of data management CRO, organize and facilitate internal team data review, and performs hands-on data review as needed. Liaise with 3^rd party vendors to facilitate routine data transfers in a consistent format. Contribute to the evaluation and implementation of clinical data collection systems, processes, and service providers.

KEY RESPONSIBILITIES:

• Participate as the primary data management representative on multidisciplinary project teams and ensure effective communication exchange.
• Provide a high level of expertise in data management of oncology clinical studies, including areas such as: electronic Case Report Form (eCRF) design, electronic data capture (EDC) database design, data management plans, edit checks/data quality review plans, query resolution processes, data transfers, SAE/AE reconciliation, thesaurus coding processes, vendor oversight plans and database lock.
• Effectively manage data management Clinical Research Organizations (CROs) to provide routine metrics, high compliance, and high-quality deliverables within timeline and budget
• Oversee and conduct quality review of clinical trial data
• Manage time and resource constraints across multiple projects.
• Ensure data management components of the Trial Master File maintained by the CRO are complete and inspection-ready at all times.
• Develop and implement new or improved processes for data management.
• Participate in development of Request For Proposals (RFPs) and evaluation of vendors, products and proposals.
• Provides oversight on quality and timeliness of task completion by direct reports.
• Develops and implement training curriculum for data management activities and principles as required.

SUPERVISORY RESPONSIBILITIES:

• Directly supervises zero to 4 employees or contractors
• Indirectly supervise employee (s) through a dotted line structure or via other subordinate supervisors.

EDUCATION/EXPERIENCE/SKILLS:   

Education:

• BS/BA degree in related discipline and 8 years of related experience; or,
• MS/MA degree in related discipline and 7 years of related experience; or,
• Equivalent combination of education and experience.

Experience:

• Typically requires a minimum of 10 years of related experience and/or combination of experience and education/training.
• Experience in Biotech/Pharmaceutical industry with oncology focus preferred.

Knowledge/Skills/Abilities:

• Experience in solid-tumor oncology clinical trials required.
• Expertise with EDC systems, e.g. RAVE, Inform
• Experience with eCRF design for solid-tumor oncology
• Deep understanding of the nuances of solid-tumor oncology data to facilitate development of data review checks and ability to drive/adjudicate/prioritize data queries.
• Demonstrated success managing data management activities of Clinical Research Organizations (CROs).
• Ability to train and oversee cross-functional staff on key data management tasks, including eCRF/EDC design, data quality review, and standardized data transfers.
• Knowledge of Good Clinical Practices (GCP) is essential.

Pay Scale:

The annualized pay scale for this exempt position is: $155,000 to $180,000, commensurate with experience.  We believe this to be possible compensation for this role at the time of this posting, and we may modify this pay scale in the future.