Vice President, Medical Affairs

Vice President, Medical Affairs

Indero has retained Pender & Howe to lead the recruitment initiative for their Vice President, Medical Affairs position. 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 is a broader mandate than a Medical Monitoring leadership role: it 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. Because the two functions sit at different points in a trial's lifecycle but share a single safety and quality lens, the role calls for a leader equally comfortable adjudicating a complex protocol-level medical decision and defending a PV inspection finding to a health authority.

This opportunity will appeal to a physician executive who has already led and scaled a Medical Monitoring or Pharmacovigilance function inside a CRO or pharmaceutical organization, who is comfortable owning a budget and revenue targets alongside patient safety and quality outcomes, and who wants a genuine seat at the table shaping Indero's next chapter of growth.

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, including protocol-related medical decisions, safety signal identification, and sponsor-facing medical disputes.

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 in signal detection, case processing, and literature monitoring.
• Lead the organization's readiness for PV regulatory inspections and internal audits, serving as a key spokesperson during health authority interactions related to pharmacovigilance.
• 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 in case processing, medical coding (MedDRA), safety signal evaluation, and regulatory reporting.

Business Development & Client Engagement

• Partner with Business Development to win new business, with particular focus on full-service Medical Affairs engagements.
• Participate in client presentations, bid defense meetings, and RFP responses, articulating Indero's Medical Affairs value proposition.
• Develop and nurture strategic client relationships, acting as the senior medical point of contact for key accounts to drive satisfaction and long-term retention.
• Lead development of competitive pricing models for Medical Affairs services in collaboration with Finance and Business Development, ensuring quotes reflect realistic resourcing and margin targets.
• Represent Indero in scientific and industry forums to build the organization's thought leadership and brand in Medical Affairs.

Quality, Compliance & Regulatory

• Ensure all Medical Affairs activities comply with applicable regulations, Indero's Quality Management System (QMS), and sponsor requirements.
• Serve as executive-level signatory and accountability owner for Medical Affairs SOPs, quality plans, CAPA plans, and audit/inspection responses.
• Partner with Quality Assurance to define audit schedules for Medical Monitoring and PV, and to review and close audit findings in a timely, thorough manner.
• Monitor evolving global regulatory requirements relevant to Medical Affairs and proactively prepare the division for them.
• Build a quality-first culture and hold the Medical Affairs team accountable for regulatory compliance and data integrity at every level.

People Leadership, Talent & Organizational Development

• Lead, mentor, and inspire a multidisciplinary Medical Affairs team.
• Design and implement a workforce planning strategy that anticipates staffing needs based on pipeline growth, therapeutic area expansion, and geographic diversification.
• Foster a psychologically safe, inclusive, high-performance culture where talent is developed, recognized, and retained.
• Develop and execute career pathing, succession planning, and leadership development programs to build a robust internal talent pipeline.
• Establish performance management frameworks and KPIs for all Medical Affairs functions, and deliver regular coaching and developmental feedback.
• Partner with HR on compensation benchmarking, onboarding, and retention strategy for medical and scientific talent in a competitive market.

Requirements

Ideal Profile

Education

• Medical doctor (MD, DO, or equivalent international medical degree) required.
• Board certification in dermatology or rheumatology is an asset but not required; a strong generalist physician background is acceptable.
• 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, including 5-7 years in a leadership role within a CRO, pharmaceutical company, or hybrid organization.
• Demonstrated experience leading and scaling Medical Monitoring and Pharmacovigilance functions.
• Proven track record of client engagement in a commercial, revenue-generating environment.
• Deep expertise in global clinical trial regulatory frameworks.
• Meaningful exposure to multiple therapeutic areas.
• Experience with health authority interactions, regulatory inspections, and audit defense.
• 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 or presentations at major clinical/scientific conferences.
• Multilingual capability or international regulatory experience.

Our company

Indero has retained Pender & Howe to lead the recruitment initiative for their Vice President, Medical Affairs position. Pender & Howe is a North American talent advisory firm specializing in leadership recruitment and consulting. We partner with organizations to build high-performing leadership teams, optimize board effectiveness, and support executive career transitions.

Our team of accomplished consultants brings