Vice President, Medical Affairs

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

📋 Description

• Formulate and implement the long-term strategic vision for the Medical Affairs division alongside the CMSO.

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

• Develop capability roadmaps for Medical Monitoring and Pharmacovigilance.

• Represent Medical Affairs in the Operational Leadership Team and provide counsel to the CMSO regarding medical, scientific, and safety risks.

• Foster collaboration among Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Scientific Affairs, and Business Development.

• Oversee medical monitoring for Indero's clinical trial portfolio at an executive level.

• Direct physician resourcing efforts, including recruitment, training, deployment, and performance evaluation.

• Uphold medical monitoring SOPs, work instructions, and quality standards.

• Address complex or high-risk medical monitoring issues and sponsor-related medical conflicts.

• Provide strategic and operational leadership in pharmacovigilance, covering case processing, signal detection, aggregate reporting, and regulatory submissions.

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

• Lead preparations for PV regulatory inspections and internal audits.

• Collaborate with sponsors on PVAs and SDEAs.

• Work with Business Development on RFPs, client presentations, bid defenses, pricing, and new business initiatives.

• Act as the senior medical point of contact for key sponsor accounts.

• Represent Indero at scientific and industry events.

• Ensure compliance of Medical Affairs with regulations, the QMS, and sponsor demands.

• Manage Medical Affairs SOPs, quality plans, CAPA plans, and executive-level audit/inspection responses.

• Lead, mentor, and develop a multidisciplinary Medical Affairs team.

• Establish workforce planning, career progression, succession planning, leadership development, performance frameworks, and KPIs.

⛳️ Requirements

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

• 12-15 years of progressively responsible experience in the pharmaceutical, biopharmaceutical, or clinical research sectors.

• 5-7 years in a leadership position within a CRO, pharmaceutical company, or hybrid entity.

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

• A successful track record of client engagement in a commercial, revenue-generating setting.

• Extensive knowledge of global clinical trial regulatory frameworks.

• Significant exposure to various therapeutic areas.

• Experience with health authority interactions, regulatory inspections, and audit defenses.

• Experience in managing P&L or budget responsibilities.

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

• Advanced business education (e.g., MBA) is beneficial but not essential.

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

• Exposure to AI-assisted technologies in medical monitoring, PV, or medical writing processes.

• Published work in peer-reviewed scientific journals or presentations at significant clinical/scientific conferences.

• Multilingual skills or international regulatory experience.

• Eligibility to work legally in North America.

• Willingness to travel frequently.

🏝️ Benefits

• Competitive salary with performance-based incentives.

• Comprehensive benefits package.

• Attractive opportunities for advancement.

• Engaging work environment.

• Remote position with frequent travel requirements.