Jobs · Legal

Senior Director, Compliance

Inventiva Pharma · Greater Boston · 3 wk ago
RemoteRemoteLegalFull-time

About the role

The Senior Director, Compliance will lead and scale Inventiva's global compliance and data privacy programs. Reporting to the Chief Legal Officer, this role supports late-stage clinical operations and helps establish the foundation for post-readout readiness and future commercialization.

Responsibilities

  • Lead the design, implementation, and continuous improvement of global healthcare compliance programs aligned with evolving laws, regulations, and industry codes
  • Partner cross-functionally to support adherence to healthcare compliance requirements and ethical standards
  • Develop, maintain, and update compliance policies, procedures, and processes to meet global requirements
  • Develop and deliver compliance training programs that promote understanding of and adherence to company policies
  • Implement and manage compliance systems and tools (e.g., HCP engagement, analytics, monitoring platforms)
  • Support enterprise-wide compliance risk assessments and contribute to the annual compliance workplan
  • Partner with the Data Protection Officer (DPO), Legal, and IT to support a comprehensive global data privacy program aligned with HIPAA, GDPR, CCPA/CPRA, and other applicable regulations
  • Assist in conducting Data Protection Impact Assessments (DPIAs) and privacy risk assessments across clinical trials and third-party vendor relationships
  • Implement systems and procedures to ensure compliance with global transparency and spend reporting requirements
  • Partner cross-functionally to establish procedures for the development, review, and approval of publications and promotional materials
  • Lead the Medical, Legal, and Regulatory (MLR) review committee
  • Conduct and support monitoring and auditing activities to assess program effectiveness and identify compliance risks
  • Lead and support internal compliance investigations through resolution and reporting to leadership
  • Administer compliance reporting channels (e.g., helpline) and promote a strong speak-up culture across the organization
  • Proactively identify inefficiencies within compliance and privacy programs and implement enhancements

Qualifications

  • Degree in Law or a related field required
  • Minimum of 10 years of healthcare compliance experience, preferably within biotech or pharmaceutical organizations
  • Strong working knowledge of global healthcare regulations, compliance frameworks, and industry codes
  • Demonstrated experience supporting late-stage clinical development and readiness for commercialization

Core Skills & Competencies

  • Healthcare compliance and ethics
  • Risk assessment, monitoring, and auditing
  • Investigations and issue management
  • Policy development and governance
  • Data privacy and regulatory interpretation
  • Strong analytical, communication, and project management skills
  • Ability to manage multiple priorities in a fast-paced, evolving environment

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