Director, Data Management

About the job Director, Data Management Job Title: Director, Data Management Job Location: United States Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Director About Apogee TherapeuticsFounded 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."We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.If this sounds like you, keep reading!Role SummaryWe 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 trialsresearch (Phase I-IV), including participating in defining corporate practices required for handling the data. In this role you will build the DM standardsgood practices as well to mentor junior data manager(s).Key ResponsibilitiesProvide operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standardsCoordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reportsEnsure 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 locksResponsible for building effective DM vendor relationships including being involved in RFP development, contract negotiation and selection of DM CROs andor technology, as neededWork closely with CROs to prepare and ensure proper development and execution of data management activitiesReview protocols to ensure database feasibilityProvide effective oversight of all CRO data management related deliverablesEnsure 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 submissionsCollaborate with Biostatistics and Statistical Programming to develop data review standards and tools, including visualization tools if neededWork collaboratively with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, Pharmacovigilance and other functions to deliver high quality data in timely fashionResponsible for documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is audit-readyEnsure that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFsResponsible 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 requirementsBuild and mentor a team of data manager(s) to effectively support clinical trials and pipelinesIdeal CandidateBachelor's Degree in health-related fieldMinimum of 10 years of clinical data management in pharmabiotechhealthcare industryMinimum of 5 years of direct people management experience, including a remote workforceMust be able to demonstrate extensive experience in the design, execution, collection, and cleaning of data for clinical studiesTechnology proficiency in Data Management SystemsKnowledge of clinical research including regulatory requirements GCPICH Data QualityExtensive experience managing CROs and other data vendorsSubmission experience (NDA, sNDA and BLAs)Knowledge of Good Clinical PracticeEDC and eCOA experience (Medidata, Veeva, etc.)Excellent written and oral communication skillsAbility to keep pace in a fast-moving organization and navigate ambiguityExperience working in a remote virtual environmentSuccessfully exhibit Apogee's C.O.R.E. values: Caring, Original, Resilient and EgolessThis position requires up to 10% travel to company and teamfunctional meetingsThe 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 OfferA great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and EgolessOpportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quicklyMarket competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefitsFlexible PTOTwo, one-week company-wide shutdowns each yearCommitment to growing you professionally and providing access to resources to further your developmentApogee offers regular all team, in-person meetings to build relationships and problem solveE-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.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.To review our privacy policy, click here Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.For more details and to find similar roles, please check out the below Lifelancer link.

Created: 2025-01-27