Director, Data Management

About Apogee Therapeutics

Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.

Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”

If this sounds like you, keep reading!

Role Summary

We are seeking a Director of Data Management. In this position you will be responsible for both management and technical aspects of Data Management elements of clinical trials. You will manage the direction, planning, execution, and interpretation of all the data management activities related to clinical trials/research (Phase I-IV), including participating in defining corporate practices required for handling the data. In this role you will build the DM standards/good practices as well to mentor junior data manager(s).

Key Responsibilities

• Provide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
• Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports
• Ensure the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks
• Responsible for building effective DM vendor relationships including being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed
• Work closely with CROs to prepare and ensure proper development and execution of data management activities
• Review protocols to ensure database feasibility
• Provide effective oversight of all CRO data management related deliverables
• Ensure that eCRFs, database interfaces, programmed edit checks and external data files, CRF completion guidelines are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submissions
• Collaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if needed
• Work collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashion
• Responsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is audit-ready
• Ensure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs
• Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.)
• Ensure that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements
• Build and mentor a team of data manager(s) to effectively support clinical trials and pipelines

Ideal Candidate

• Bachelor’s Degree in health-related field
• Minimum of 10 years of clinical data management in pharma/biotech/healthcare industry
• Minimum of 5 years of direct people management experience, including a remote workforce
• Must be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studies
• Technology proficiency in Data Management Systems
• Knowledge of clinical research including regulatory requirements GCP/ICH Data Quality
• Extensive experience managing CROs and other data vendors
• Submission experience (NDA, sNDA and BLAs)
• Knowledge of Good Clinical Practice
• EDC and eCOA experience (Medidata, Veeva, etc.)
• Excellent written and oral communication skills
• Ability to keep pace in a fast-moving organization and navigate ambiguity
• Experience working in a remote virtual environment
• Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
• This position requires up to 10% travel to company and team/functional meetings

The anticipated salary range for candidates for this role will be $225,000-$245,000. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography. 

What We Offer

Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.

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