Vice President, Medical Affairs

The Vice President, Medical Affairs is a newly defined executive mandate created to bring Indero's Medical Monitoring and Pharmacovigilance (PV) functions under unified, senior physician leadership as the organization scales across a growing therapeutic and geographic footprint. This role carries P&L accountability for both functions, a direct hand in business development and client-facing bid defense, and a seat at the Operational Leadership Team table advising the Chief Medical & Scientific Officer (CMSO) on medical, scientific, and safety risk across the trial portfolio.

As Indero's study footprint extends from North America and Europe into Asia Pacific, this role will be central to ensuring medical and safety standards scale consistently with the organization's growth. Reporting to the Executive and leading the Global, Medical Monitoring and Pharmacovigilance function, the VP will set strategic direction for both functions - from physician resourcing and medical monitoring SOPs to PV case processing, signal detection, aggregate reporting, and regulatory inspection readiness, while safeguarding the safety of trial participants, the integrity of clinical data, and the quality of every deliverable the organization produces.

This is a global team of roughly 20 across Medical Monitoring, Pharmacovigilance, and medical project operations, with three functional leaders reporting directly to the VP. The role also carries meaningful external accountability.

The VP will partner with Business Development and Proposals on RFP responses and full-service Medical Affairs engagements, participate directly in client presentations and bid defenses, and serve as the senior medical point of contact for key sponsor accounts.

RESPONSIBILITIES

• Strategic Leadership & Division Management
  • Partner with the CMSO to develop and execute the long-term strategic vision for the Medical Affairs division, aligned with Indero's overall growth strategy and competitive positioning in the CRO marketplace.
  • Own the operating budget and P&L for the Medical Monitoring and Pharmacovigilance functions, ensuring financial discipline, resource optimization, and delivery against revenue and margin targets.
  • Build short- and long-term capability roadmaps for Medical Monitoring and Pharmacovigilance that keep pace with evolving regulatory requirements, sponsor needs, and industry best practice.
  • Champion a culture of scientific excellence, patient safety, operational rigor, and continuous quality improvement across Medical Affairs.
  • Represent Medical Affairs at the Operational Leadership Team level, serving as a key advisor to the CMSO on medical, scientific, and safety risk matters.
  • Drive cross-divisional collaboration with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Scientific Affairs and Business Development to ensure integrated program delivery.
• Medical Monitoring Oversight
  • Provide executive oversight of all medical monitoring activity across Indero's clinical trial portfolio, spanning multiple therapeutic areas.
  • Ensure medical monitoring teams deliver high-quality, protocol-compliant medical oversight.
  • Maintain and evolve Indero's medical monitoring model to meet diverse client needs and therapeutic complexity.
  • Lead physician resourcing strategy, including hiring, training, deployment, and performance management.
  • Ensure Medical Monitoring SOPs, work instructions, and quality standards are maintained, reviewed, and compliant with applicable regulatory guidelines.
  • Serve as the escalation point for complex or high-risk medical monitoring issues.
• Pharmacovigilance Oversight
  • Provide strategic and operational oversight of the PV function, ensuring robust, audit-ready systems for case processing, signal detection, aggregate reporting, and regulatory submissions.
  • Ensure the organization meets its pharmacovigilance obligations across global jurisdictions and country-specific PV legislation.
  • Oversee preparation and quality review of aggregate safety reports to meet sponsor and regulatory deadlines with accuracy and scientific integrity.
  • Champion the evolution of PV technology platforms and evaluate AI- and automation-driven efficiencies.
  • Lead the organization's readiness for PV regulatory inspections and internal audits.
  • Partner with sponsor Medical Safety Officers and PV teams to establish and maintain transparent pharmacovigilance agreements (PVAs) and safety data exchange agreements (SDEAs).
  • Ensure ongoing training and competency assessment of PV staff.
• Business Development & Client Engagement
  • Partner with Business Development to win new business, focusing on full-service Medical Affairs engagements.
  • Participate in client presentations, bid defense meetings, and RFP responses.
  • Develop and nurture strategic client relationships, acting as the senior medical point of contact for key accounts.
  • Lead development of competitive pricing models for Medical Affairs services.
  • Represent Indero in scientific and industry forums.
• Quality, Compliance & Regulatory
  • Ensure all Medical Affairs activities comply with applicable regulations and sponsor requirements.
  • Serve as executive-level signatory and accountability owner for Medical Affairs SOPs.
  • Partner with Quality Assurance to define audit schedules and review audit findings.
  • Monitor evolving global regulatory requirements relevant to Medical Affairs.
  • Build a quality-first culture and hold the Medical Affairs team accountable for regulatory compliance.
• People Leadership, Talent & Organizational Development
  • Lead, mentor, and inspire a multidisciplinary Medical Affairs team.
  • Design and implement a workforce planning strategy.
  • Foster a psychologically safe, inclusive, high-performance culture.
  • Develop and execute career pathing, succession planning, and leadership development programs.
  • Establish performance management frameworks and KPIs for all Medical Affairs functions.

Requirements:

• Education
  • Medical doctor (MD, DO, or equivalent international medical degree) required.
  • Board certification in dermatology or rheumatology is an asset but not required.
  • Advanced business training (e.g., MBA) is an asset but not required.
• Professional Experience
  • 12-15 years of progressive experience in the pharmaceutical, biopharmaceutical, or clinical research industry.
  • Demonstrated experience leading and scaling Medical Monitoring and Pharmacovigilance functions.
  • Proven track record of client engagement in a commercial environment.
  • Deep expertise in global clinical trial regulatory frameworks.
  • Meaningful exposure to multiple therapeutic areas.
  • Experience with health authority interactions and regulatory inspections.
  • Experience managing P&L or budget responsibility.
• Preferred Qualifications
  • Experience building or scaling an established Medical Affairs function.
  • Working knowledge of PV safety databases and safety reporting automation tools.
  • Exposure to AI-assisted technologies in medical monitoring, PV, or medical writing workflows.
  • Published authorship of peer-reviewed scientific manuscripts.
  • Multilingual capability or international regulatory experience.

About Indero

Indero is a contract research organization (CRO) specialized in dermatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals.