Director, Global R&D Compliance
Listing location: USFull-TimeDirector
Salary193,300 - 253,300 USD per year
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Job Details
- Experience
- 10+ years of experience in compliance, legal, or R&D within the biopharmaceutical or life sciences industry
- Required Skills
- ComplianceCross-functional collaborationHIPAA
Requirements
- Bachelor’s degree required; advanced degree (JD, MBA, MPH, or scientific field) strongly preferred
- 10+ years of experience in compliance, legal, or R&D within the biopharmaceutical or life sciences industry
- Strong knowledge of global clinical development, regulatory frameworks, and research operations
- Deep understanding of applicable laws and standards, including FDA, EMA, ICH-GCP, HIPAA, and anti-corruption regulations
- Proven ability to act as a strategic advisor while maintaining independence and sound judgment
- Excellent communication and influencing skills, with the ability to engage senior stakeholders across global functions
- Strong analytical, risk assessment, and problem-solving capabilities in complex environments
- Experience working in matrixed, global organizations with cross-functional collaboration
- Ability to manage multiple priorities autonomously while maintaining high ethical standards
- Travel required approximately 30%
Responsibilities
- Serve as a strategic compliance partner to Global R&D and Medical Affairs, providing real-time guidance on clinical, scientific, and research activities
- Oversee compliance risk management for interactions with healthcare professionals, organizations, and research stakeholders, ensuring alignment with global regulations and internal policies
- Lead the development, implementation, and maintenance of global R&D compliance policies, SOPs, and governance frameworks
- Design and deliver role-based compliance training programs to strengthen awareness, ethical decision-making, and regulatory adherence
- Conduct compliance monitoring, audits, and risk assessments, including tracking KPIs and supporting corrective and preventive actions
- Partner with Legal, Regulatory Affairs, Quality, and Internal Audit teams to ensure consistent compliance oversight and issue resolution
- Evaluate emerging regulatory developments and industry standards to anticipate and mitigate evolving compliance risks
- Support oversight of ethical engagement practices across clinical trials, advisory activities, and scientific collaborations
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