Director, Life Sciences Compliance

Summary

Join Datavant as a Director of Life Sciences Compliance and develop, manage, and ensure compliance with GCP and other standards across the company. You will be the primary compliance leader for life sciences initiatives, working with partners and auditors to ensure solutions meet regulatory requirements. This critical role involves designing and implementing the GCP compliance program, providing strategic guidance to senior leadership, and serving as a compliance liaison. You will lead compliance initiatives, risk assessments, and audit preparations, collaborating with various internal stakeholders. The position requires a JD or Master's degree, 8+ years of relevant experience (including 3+ years managing GCP functions), and strong leadership and cross-functional skills.

Requirements

• JD or Master’s Degree
• 8+ years’ relevant experience, including at least 3 years managing high-performing GCP functions in the pharmaceutical industry
• Experience working in a matrixed organization
• A brand as a strong leader that delivers excellence
• Strong cross-functional experience
• Proven ability to lead and influence across an organization
• You can clearly define what good looks like and execute the plan to get there
• You are ambitious, scrappy, tenacious, and you get things done
• You are comfortable making hard decisions in fast-paced, ambiguous environments and moving quickly
• You are highly organized and reliable (you always keep commitments)
• You bring clarity and structure to complexity

Responsibilities

• Design, implement, manage, and report Datavant’s GCP compliance program, ensuring adherence to regulatory requirements and industry best practices
• Provide strategic guidance to senior leadership on compliance-related business decisions
• Maintain a deep understanding of the Common Rule, data privacy requirements, GCP, ICH guidelines, and 21 CFR Part 11 to ensure Datavant clinical data, processes, and systems comply with relevant laws
• Serve as the primary compliance liaison with life sciences partners, regulatory bodies, and auditors
• Lead strategic compliance initiatives and risk assessments across the organization's life sciences activities, with support from the Chief Compliance and Privacy Officer
• Direct the development and implementation of compliance policies, procedures, and training programs to ensure organizational adherence to regulatory requirements
• Lead preparations for and responses to audits and inspections, ensuring the company's readiness and compliance
• Lead the development and execution of Corrective and Preventive Actions (CAPA) to address any identified compliance gaps or deficiencies, ensuring timely resolution
• Collaborate with Sales, Legal, Technology, and other critical internal stakeholders to review, update, and improve policies, procedures, processes, systems, and agreements to align with GCP and other applicable requirements
• Develop and manage GCP training programs for internal teams to strengthen understanding of compliance requirements
• Identify areas of non-compliance or risk and develop mitigation plans
• Partner with internal audit function to monitor compliance and drive continuous improvement
• Ensure the proper maintenance of documentation in compliance with GCP standards, including protocols, procedures, and audit trails
• Lead impactful efforts with a hands-on approach, ensuring high-quality execution
• Serve as a strong communicator, coach, and mentor within the organization

Preferred Qualifications

• Relevant certifications (e.g., RAC, RAPS)
• Experience in health information technology or data analytics
• Program and project management experience
• International regulatory compliance experience

Benefits

Salary range: $165,000 - $245,000