Vice President Medical Services and Strategy

About the Role

As a global CRO, we are looking for a highly qualified and experienced Global Head of Medical Services to manage all physicians across North America, Europe, and APAC. The ideal candidate will have a global mindset, strong leadership skills, commitment to excellence in medical governance and the protection of human safety, and strong business acumen. This role will be accountable for the division's Profit and Loss. This is a senior leadership position based in the United States.

This role is accountable for the global organization encompassing the Medical Services group that provides medical monitoring services and clinical development advice. This role will ensure the highest standards of medical and safety governance and oversight for all medical activities executed within the organization. In addition, this role will be responsible for the financial performance of this global function. This role plays a pivotal role in providing strategic direction, leadership, and guidance to a team of medical advisors, and collaborates closely with other departments to support the successful execution of clinical trials.

Responsibilities

Leadership and Strategy

• Optimize and implement the medical monitoring strategy in alignment with the company's overall goals and objectives.
• Provide visionary leadership to the medical advising team, fostering a culture of excellence, innovation, and continuous improvement.
• Collaborate with the CMO and other senior leadership to drive the organization's growth and profitability.

Medical/Clinical Oversight

• Act as the point of escalation for medical and safety issues related to clinical trials, serving as an expert resource for the organization.
• Ensure the highest standards of medical and safety monitoring for patient safety in clinical trials, from early-phase studies to late-phase trials.
• Review and approve project scope and budgets with respect to medical services.

Team Management

• Recruit, develop, and manage a team of medical advisors, providing guidance, mentorship, and professional development opportunities.
• Oversee the day-to-day operations of the Medical Services department, including policy and procedure, workload management and resource allocation.

Regulatory Compliance

Stay current with ICH/GCP and relevant regulatory requirements and guidelines related to clinical trials and medical monitoring, ensuring the company's adherence to all applicable regulations and standards.

Risk Management

Provide strategic oversight of quality risk management, supporting proactive identification, mitigation and escalation of significant quality and compliance risks associated with clinical trials and company policies and procedures. Partner with Quality Assurance and other functions to provide medical leadership and oversight of quality risk management, ensuring medical and patient safety risks are proactively identified, assessed, mitigated and appropriately escalated.

Cross-functional Collaboration

• Work cross-functionally (project management, clinical operations, data management, biostatistics, and regulatory affairs etc.) to ensure seamless execution of clinical trials.
• Work closely with commercial teams and the Medical and Scientific Strategists and Drug Development Consulting groups to cultivate sponsor relationships that contribute to study awards.
• Foster strong working relationships with external medical experts and Key Opinion Leaders (KOLs).
• Foster strong working relationships with external sites and investigators.
• Foster strong working relationships with physician staff within our sponsor partners.

Quality Assurance

• Implement and oversee quality control measures to maintain the highest standards of medical monitoring and safety.
• Develop and monitor key performance indicators (KPIs) to assess the effectiveness of medical monitoring activities.

Financial Management

• Manage the department's budget, ensuring cost-effective allocation of resources and optimal financial performance.
• Manage the department's profit margins, utilization, and realization.

Experience & Qualifications

• Medical Doctor (MD) or equivalent medical degree in the United States.
• Significant experience (typically 15+ years) in a medical role in industry (large pharm, biotech, CRO), including experience in medical monitoring, clinical development, and leadership roles.
• Strong understanding of clinical trial regulations, Good Clinical Practice (GCP), and safety reporting requirements.
• Proven leadership and team management skills.
• A history of global leadership preferred.
• Strong business acumen.
• Excellent communication, negotiation, and problem-solving abilities.
• Ability to work effectively in a fast-paced and dynamic environment.
• Advanced knowledge of clinical data and safety databases is a plus.