Evidence Generation Operations & Compliance Director
On-siteCambridge, Massachusetts, United States
Job Summary
Establish enterprise-level governance, operational standards, and compliance leadership for Medical-led evidence generation activities within Global Medical. Serve as the primary Medical Governance Office lead, ensuring consistent oversight, quality, risk management, and inspection readiness across research activities. Define governance pathways, decision rights, and documentation requirements while leveraging data, automation, and AI to enhance transparency and proactive decision-making. Partner with R&D Quality Assurance, Ethics, Legal, and Regulatory teams to align expectations with applicable laws, industry codes, and enterprise frameworks. Support audit readiness through documentation standards, issue escalation, and remediation follow-up, while developing operating materials like playbooks, checklists, and training guides. Drive continuous improvement and capability building across Global, US, Oncology, and International Medical teams in a regulated, matrixed environment.
Required Qualifications
- Degree in life sciences, pharmacy, medicine, public health, healthcare management, or related discipline
- 10+ years of relevant experience in Medical Affairs, evidence generation/RWE operations, medical governance, research operations, quality, compliance or related functions
- Experience supporting governance or operational oversight of Medical-led evidence generation activities, including process standards, documentation requirements, risk assessment, external partner oversight, issue management and audit readiness
- Working knowledge of applicable laws, regulations, company SOPs, data privacy, pharmacovigilance considerations, data integrity expectations and relevant industry codes
- Experience developing or improving governance frameworks, SOPs, operating guidance, committee processes, dashboards, tracking tools, documentation standards or cross-functional ways of working
- Strong governance, risk-based thinking and systems-thinking capability, with the ability to anticipate evolving regulatory, quality, technological and AI-related implications for evidence generation operations
- Strong understanding of quality systems, risk-based oversight methodologies and the application of enterprise quality frameworks within evidence generation and research operations environments
- Demonstrated ability to leverage digital technologies, advanced analytics and emerging AI capabilities to improve governance effectiveness, operational efficiency, compliance monitoring and decision-making
- Ability to translate complex requirements into simple, practical tools and guidance
- Excellent communication, influence and stakeholder-management skills across cultures, functions and seniority levels
- Executive communication skills, with the ability to frame status, implications, risks and recommendations clearly
- Ability to balance compliance rigor with operational practicality while maintaining strong patient, scientific, quality, privacy and safety safeguards
- High attention to detail, clarity and documentation quality, with sound judgment in sensitive or reputationally important situations
- Ability to support transformation and change adoption in a patient-first, science-led and ethically grounded Medical culture
Desired Qualifications
- Experience working in global, regional or matrix environments with multiple stakeholders and varied local requirements
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