Director, Life Sciences Compliance

2 days ago

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Datavant

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

⚕️ Healthcare Insurance

☁️ SaaS

🏢 Enterprise

💰 $40M Series B on 2020-10

Description

• 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.

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