Director, Life Sciences Compliance

Datavant is a data platform company and the world’s leader in health data exchange. Our vision is that every healthcare decision is powered by the right data, at the right time, in the right format.

Our platform is powered by the largest, most diverse health data network in the U.S., enabling data to be secure, accessible and usable to inform better health decisions. Datavant is trusted by the world’s leading life sciences companies, government agencies, and those who deliver and pay for care. 

By joining Datavant today, you’re stepping onto a high-performing, values-driven team. Together, we’re rising to the challenge of tackling some of healthcare’s most complex problems with technology-forward solutions. Datavanters bring a diversity of professional, educational and life experiences to realize our bold vision for healthcare.

Datavant is a data platform company for healthcare whose products and solutions enable organizations to move and connect data securely. Datavant has a network of networks, consisting of thousands of organizations, more than 70,000 hospitals and clinics, 70% of the 100 largest health systems, and an ecosystem of 500+ real-world data partners.

By joining Datavant today, you’re stepping into a highly collaborative team that is passionate about creating transformative change in healthcare. We invest in our people and believe in hiring high-potential and humble individuals who can rapidly grow their responsibilities as the company scales. 

As a Director of Life Sciences Compliance, you will develop, manage, and ensure compliance with Good Clinical Practice (GCP) and other applicable standards across Datavant, in support of relationships with life sciences, medical device, and pharmaceutical industry customers.  This role will serve as the primary compliance leader for our life sciences initiatives, working closely with pharmaceutical, biotechnology, and healthcare partners (as well as auditors) to ensure our solutions meet rigorous regulatory requirements while enabling innovative research and development. This role will be critical in ensuring that our data and processes align with GCP, 21 CFR Part 11, and related compliance commitments to our customers.

In this role you will:

• 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.

Required Qualifications:

• 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 do