Senior Director, Compliance & Ethics, Global R&D

Role Summary

Senior Director, Compliance & Ethics, Global R&D. Strategic business partner and compliance advisor to global R&D functions (Global Medical Affairs, Global Pharmacovigilance, Global Health Economics Values and Outcomes) and US Medical Affairs. Lead culture of compliance & ethics, oversee Global R&D Compliance & Ethics Policy and SOPs, supervise monitoring activities, and contribute to department strategy.

Responsibilities

• Provide coaching, education and guidance to senior R&D executives to enable accountability for the R&D compliance program and ethical culture.
• Provide compliance risk assessment, education, oversight and guidance for Global R&D and USMA functions to ensure activities comply with laws, codes and best practices.
• Ensure interactions with HCPs, HCOs, patients/study subjects, patient advocacy groups, caregivers, and other healthcare community members comply with policies and SOPs through communication and monitoring.
• Participate in cross-functional teams, offering risk mitigation guidance and corrective actions with Compliance, Legal, HR, Medical Affairs, and other functions.
• Develop, maintain and deliver communications and training programs aligned with evolving work environment.
• Analyze external enforcement trends to identify compliance vulnerabilities and inform risk-based decisions.
• Provide ad hoc support and guidance to other Compliance colleagues as needed.
• Follow Safety, Health, and Environmental policies and procedures.
• Other projects and duties as required/assigned.

Qualifications

• Bachelor’s degree required; advanced degree (Masters or JD) preferred.
• Minimum 10 years’ experience in healthcare/pharmaceuticals, with at least 5 years in a compliance/risk role.
• Minimum 5 years of supervisory or people leadership experience.
• Strong leadership with strategy development experience and ability to interact with partners and customers in the pharmaceutical industry.
• Extensive knowledge of Clinical/Pre-Clinical Research, Generics, Medical Affairs, Pharmacovigilance, Health Economics & Outcomes Research, Regulatory, Legal, and HR.
• Knowledge of regulatory environment surrounding non-promotional scientific exchange, trials, pharmacovigilance, health economics, and payer relations; GCP/GMP/GLP standards.
• Experience with compliance policies, SOPs, and data privacy; policy development experience.
• Strong interpersonal, cross-functional collaboration, and leadership-by-influence skills; ability to work independently.
• Project management skills; ability to manage large multi-stakeholder projects.
• Ability to partner with multiple R&D units and influence across levels; strong written/verbal communication and training material development.
• Strategic thinker, able to analyze regulations and industry guidance; capable of identifying risks and proposing practical solutions.
• Customer-oriented, collaborative, able to maintain confidentiality across cultures/time zones.

Education

• Bachelor’s Degree required; advanced degree preferred.

Additional Requirements

• Travel: Business travel required for some projects (approximately 30%).