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