Senior Director Data Management

Senior Director Data Management

Lantheus is headquartered in Bedford, Massachusetts with offices in Canada and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. In 2023, Lantheus had more than $1B in revenues, led by sales of imaging agents for cardiac ultrasound and for prostate cancer.

Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone's health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team.

Summary of Role

The Senior Director of Data Management will lead all data management activities across clinical programs, ensuring data quality, compliance, and inspection-readiness while driving operational excellence and vendor oversight. This role is accountable for building and mentoring a high-performing internal DM team, establishing robust data governance practices, and ensuring data integrity, compliance, and readiness for regulatory submissions. Partnering closely with cross-functional teams, the Senior Director will support clinical development strategies through timely, integrated, and regulatory-compliant data delivery, with a focus on oncology, neurology, and radiopharmaceutical trials.

This position is site based and requires a presence on-site three days per week.

Key Responsibilities

• Lead and grow a best-in-class internal Data Management team; define roles, performance objectives, and career development plans.
• Promote a culture of continuous improvement, operational efficiency, and scientific rigor.
• Serve as the primary point of contact for all data management-related decisions at cross-functional leadership meetings and governance boards.
• Lead selection, contracting, onboarding, and day-to-day management of data management vendors, including EDC providers, labs, and imaging CROs.
• Ensure full alignment with performance metrics, timelines, and budgetary controls pertained to data management activities.
• Establish formal governance structures and escalation processes for vendor issue resolution.
• Ensure implementation and governance of global data standards, including CDASH, SDTM/ADaM (CDISC), and Define.xml.
• Maintain compliance with ICH-GCP, 21 CFR Part 11, and other applicable regulatory frameworks.
• Lead the development and maintenance of SOPs, data review plans, edit checks, and quality oversight processes.
• Drive inspection-readiness for all data deliverables and systems, including traceability documentation.
• Oversee the full lifecycle of clinical data: protocol review, CRF design, database build, query management, database lock, and final data transfers.
• Enable high-quality and timely data delivery for clinical study reports, safety reviews, interim analyses, and regulatory filings (e.g., NDA, BLA, MAA).
• Integrate multimodal data, including ePRO, imaging, biomarkers, and real-world data, into cohesive data sets that support precision medicine strategies.
• Partner closely with Clinical Operations, Biostatistics, Programming, Regulatory Affairs, Safety, Medical Affairs, and Translational Research to ensure alignment of data strategies with clinical development goals.
• Contribute to protocol design, data flow architecture, and endpoint optimization, ensuring statistical and regulatory needs are met.
• Support cross-functional working groups for risk-based monitoring, trial master file completeness, and centralized data cleaning strategies.

Qualifications

• Bachelor's or master's degree in Life Sciences, Health Informatics, Computer Science, or related field. Advanced degree (PhD, MPH) preferred.
• 12+ years of clinical data management experience in pharmaceutical/biotech settings, with 5+ years in a senior leadership role.
• Proven track record in managing global CROs/vendors, negotiating contracts, and leading oversight committees.
• Familiar with Medidata Rave, Veeva Vault, SAS, and industry-standard tools.
• Expert-level knowledge of CDASH, CDISC SDTM, and eCTD data requirements.
• Hands-on experience supporting regulatory submissions and participating in regulatory inspections (FDA, EMA, PMDA, etc.).
• Excellent leadership, communication, and collaboration skills; capable of influencing stakeholders across clinical development and executive leadership.

Preferred Experience

• Radiopharmaceutical, theranostic, or diagnostic imaging product development.
• Involvement in FDA Advisory Committee preparations.
• Familiarity with decentralized trials, wearable sensors, and digital biomarkers.
• Background in real-world evidence integration and post-marketing data strategies.

Core Values

• Let people be their best
• Respect one another and act as one
• Learn, adapt, and win
• Know someone's health is in our hands
• Own the solution and make it happen

Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team.