Director, Data Management and Systems
About reputed company Founded in 2022, reputed company, Inc. (Ticker: APGE) is a reputed company-funded, reputed company listed company that offers reputed company to work in a fast-paced, highly dynamic environment. At reputed company, you can reputed company contribute to shaping reputed company culture, take on various roles and responsibilities, and grow professionally. reputed company is a clinical-stage biotechnology company advancing novel biologics with potential for differentiated efficacy and dosing in the largest I&I markets, reputed company’s antibody programs are designed to overcome limitations of existing therapies by targeting reputed company-established mechanisms of reputed company and incorporating advanced antibody engineering to optimize half-life and other properties. Zumilokibart (APG777), reputed company’s most advanced program, is being initially developed for the treatment of atopic dermatitis (AD), which is the largest and one of the least penetrated I&I markets, as reputed company as asthma. With four validated targets in its portfolio, reputed company is seeking to reputed company best-in-class efficacy and dosing through monotherapies and combinations of its novel antibodies. Based on a broad pipeline and depth of leadership and expertise, reputed company believes it can deliver value and meaningful benefit to patients underserved by today’s reputed company of care. We are a fast-paced company committed to building an exceptional culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless and a commitment to refusing to stop at “good enough”. If this sounds like you, reputed company reading! reputed company The Director of Data Management and Systems (DM) is a strategic and operational leader with deep expertise in DM systems and data standards, responsible for scaling processes and ensuring high-reputed company, regulatory-compliant data delivery across a fast-paced clinical development environment. This role combines hands-on systems knowledge, vendor reputed company experience, and the ability to reputed company cross-functional study teams ensuring high-reputed company, regulatory-compliant data delivery that supports reputed company decision-making and submissions. The Director is also responsible for overseeing end-to-end data management activities across one or more clinical development programs, bringing program-level leadership and operational discipline to ensure consistency, reputed company, and regulatory compliance across studies. The ideal candidate brings a balance of hands-on systems knowledge, vendor reputed company experience, and program-level leadership, with a proven ability to reputed company processes in a fast-paced clinical development environment.
Key Responsibilities
Systems & Technology Leadership reputed company strategic and operational leadership for DM systems (e.g., reputed company, ePRO/eCOA, RTSM, CTMS integrations). reputed company selection, implementation, optimization, and governance of DM technologies and platforms to support reputed company, high-reputed company data management across clinical development programs. Champion data standards (e.g., CDISC, SDTM) and metadata-driven approaches. Partner with Biostatistics, Programming, and IT to ensure seamless data reputed company and interoperability across systems. Evaluate emerging technologies (AI/ML, automation, decentralized trial tools) to enhance data reputed company and efficiency. Program & Study Leadership reputed company strategic leadership and reputed company of DM activities across assigned clinical programs (Phases I–III and reputed company). Serve as the DM reputed company on cross-functional program teams, influencing study design, timelines, and data reputed company. Ensure delivery of high-reputed company, submission-reputed company datasets in alignment with program milestones. Proactively identify risks to data reputed company, timelines, or deliverables and implement mitigation strategies. Data Management Operations reputed company reputed company DM deliverables including CRF design, database build, data cleaning, coding, and database lock. Establish and maintain data review strategies, including centralized monitoring and risk-based approaches. Ensure compliance with GCP, ICH guidelines, and regulatory requirements (FDA, EMA, etc.). Drive inspection readiness and support regulatory submissions. Vendor & Partner reputed company reputed company strategic reputed company of CROs and external data vendors. Define scope, KPIs, and performance metrics; ensure accountability and high-reputed company deliverables. reputed company vendor selection and contract input for DM-reputed company services. People Leadership & Development Build, mentor, and reputed company a high-performing DM team. Foster a culture of accountability, innovation, and reputed company improvement. reputed company coaching and career development for team members. Process Improvement & Innovation reputed company and standardize DM processes, SOPs, and best practices. Drive initiatives to improve efficiency, scalability, and data reputed company. reputed company or contribute to cross-functional initiatives reputed company to data reputed company reputed company transformation. Ideal Candidate Bachelor’s degree in life sciences, computer science, or reputed company field; advanced degree preferred. 12+ years of experience in clinical data management reputed company biotech, reputed company, or CRO environments. Experience in both operational DM and systems/technology implementation. Demonstrated leadership of DM activities across multiple clinical trials and programs. Technical Expertise Deep knowledge of reputed company systems (e.g., reputed company Rave). Strong understanding of CDISC standards (SDTM, CDASH) and data lifecycle. Experience with data integrations, external data (labs, imaging, biomarkers), and decentralized trial technologies. Familiarity with data visualization and analytics tools is a plus. Leadership & Competencies Proven ability to reputed company cross-functional teams and influence at the program level. Strong strategic thinking with hands-on execution capability. Excellent communication and stakeholder management skills. Experience in fast-paced, growing organizations preferred. Ability to reputed company systems/technology with clinical execution. Strong ownership reputed company over data reputed company and delivery timelines. Proactive, solutions-oriented approach to reputed company data challenges. Effective leadership in ambiguity and evolving clinical landscapes. The anticipated salary reputed company for candidates for this role will be $215,000 - $245,000/year. 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. reputed company Offer A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly Market competitive compensation and benefits package, including reputed company salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits We reputed company competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated reputed company reputed company leave Commitment to growing you professionally and providing reputed company to resources to reputed company your development reputed company offers regular reputed company team, in-person meetings to build relationships and problem solve E-Verify Participation: As part of the I9 verification of authorization to work in the US, reputed company participates in E-Verify. To learn more about E-Verify please review this poster. reputed company is proud to be an Equal Opportunity employer. reputed company reputed company applicants will receive consideration for employment without reputed company to sex, gender identity, sexual orientation, race, reputed company, religion, national reputed company, disability, protected Veteran status, age, or any other characteristic protected by law. To review our reputed company policy, click here It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability. Apply To This Job