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 :

Desired Qualifications :

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We are committed to building a diverse team of Datavanters who are all responsible for stewarding a high-performance culture in which all Datavanters belong and thrive. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.

At Datavant our total rewards strategy powers a high-growth, high-performance, health technology company that rewards our employees for transforming health care through creating industry-defining data logistics products and services.

The range posted is for a given job title, which can include multiple levels. Individual rates for the same job title may differ based on their level, responsibilities, skills, and experience for a specific job.

The estimated total cash compensation range for this role is : $165,000—$245,000 USD

To ensure the safety of patients and staff, many of our clients require post-offer health screenings and proof and / or completion of various vaccinations such as the flu shot, Tdap, COVID-19, etc. Any requests to be exempted from these requirements will be reviewed by Datavant Human Resources and determined on a case-by-case basis. Depending on the state in which you will be working, exemptions may be available on the basis of disability, medical contraindications to the vaccine or any of its components, pregnancy or pregnancy-related medical conditions, and / or religion.

This job is not eligible for employment sponsorship.

Datavant is committed to a work environment free from job discrimination. We are proud to be an Equal Employment Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status.To learn more about our commitment, please review our EEO Commitment Statement here. Know Your Rights, explore the resources available through the EEOC for more information regarding your legal rights and protections.In addition, Datavant does not and will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay. Learn morehere.

At the end of this application, you will find a set of voluntary demographic questions. If you choose to respond, your answers will be anonymous and will help us identify areas for improvement in our recruitment process. (We can only see aggregate responses, not individual ones. In fact, we aren't even able to see whether you've responded.) Responding is entirely optional and will not affect your application or hiring process in any way.

Datavant is committed to working with and providing reasonable accommodations to individuals with physical and mental disabilities. If you need an accommodation while seeking employment, please contact us atpeopleteam@datavant.com. We will review your request for reasonable accommodation on a case-by-case basis.

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Salary : $165,000 - $245,000