Vice President, Medical Affairs

This is a fully remote position, open to applicants in North America.

📋 Description

• Develop and implement the long-term strategic vision for the Medical Affairs division in collaboration with the CMSO.

• Manage the operating budget and P&L for Medical Monitoring and Pharmacovigilance.

• Create capability roadmaps for Medical Monitoring and Pharmacovigilance.

• Oversee medical monitoring for the entire clinical trial portfolio at an executive level.

• Lead physician recruitment, training, deployment, and performance management.

• Maintain standard operating procedures (SOPs), work instructions, and quality standards for medical monitoring.

• Address complex or high-risk medical monitoring issues as needed.

• Provide strategic and operational direction for Pharmacovigilance, including case processing, signal detection, aggregate reporting, and regulatory submissions.

• Ensure adherence to global and country-specific pharmacovigilance regulations.

• Lead readiness for PV regulatory inspections and internal audits.

• Collaborate with sponsors regarding pharmacovigilance agreements and safety data exchange agreements.

• Work with Business Development on new opportunities, RFP responses, client presentations, and bid defenses.

• Cultivate strategic client relationships and act as the senior medical contact for key accounts.

• Develop competitive pricing models for Medical Affairs services.

• Ensure compliance with regulations, the Quality Management System (QMS), and sponsor requirements.

• Serve as the executive signatory and accountability owner for SOPs, quality plans, CAPA plans, and audit/inspection responses.

• Mentor and develop a multidisciplinary Medical Affairs team.

• Establish performance frameworks, key performance indicators (KPIs), succession planning, and leadership development initiatives.

⛳️ Requirements

• A medical degree (MD, DO, or equivalent international qualification) is required.

• 12–15 years of progressive experience in the pharmaceutical, biopharmaceutical, or clinical research sectors.

• 5–7 years in a leadership position within a Contract Research Organization (CRO), pharmaceutical firm, or hybrid organization.

• Proven experience in leading and scaling Medical Monitoring and Pharmacovigilance functions.

• A successful history of client engagement in a commercial, revenue-generating context.

• In-depth knowledge of global clinical trial regulatory frameworks.

• Significant exposure to multiple therapeutic areas.

• Experience with interactions with health authorities, regulatory inspections, and audit defense.

• Experience managing P&L or having budget responsibilities.

• Board certification in dermatology or rheumatology is advantageous but not mandatory.

• Advanced business training such as an MBA is beneficial but not required.

• Familiarity with PV safety databases and safety reporting automation tools.

• Exposure to AI-assisted technologies in medical monitoring, pharmacovigilance, or medical writing workflows.

• Authorship of published peer-reviewed scientific manuscripts or presentations at prominent clinical/scientific conferences.

• Multilingual skills or international regulatory experience is a plus.

• Must have the legal right to work in North America.

🏝️ Benefits

• Competitive salary with performance-based incentives.

• Comprehensive benefits package.

• Engaging work environment.

• Excellent opportunities for career advancement.

• Remote position with regular travel requirements.