Vice President, Medical Affairs

Accountabilities: Strategic leadership and business management: Partner with executive leadership to define and execute the long-term Medical Affairs strategy, aligned with organizational growth objectives. Oversee the operating budget and profit-and-loss performance for Medical Monitoring and Pharmacovigilance, optimize resources, and deliver against revenue and margin targets. Medical Monitoring oversight: Direct medical monitoring activities across the clinical trial portfolio, ensuring protocol compliance, scientific rigor, and patient safety. Establish physician resourcing strategies, oversee recruitment and training, maintain standard operating procedures, and act as the escalation point for complex medical decisions and safety concerns. Pharmacovigilance leadership: Oversee pharmacovigilance operations, including case processing, signal detection, aggregate safety reporting, and regulatory submissions. Maintain compliance with international and country-specific regulations, ensure audit and inspection readiness, and strengthen safety reporting processes, systems, and staff competencies. Business development and client engagement: Collaborate with commercial teams on proposals, requests for proposals, pricing strategies, client presentations, and bid defense meetings. Build and maintain strategic relationships with sponsors, serve as the senior medical contact for key accounts, and contribute to business growth and long-term client retention. Quality, compliance, and regulatory oversight: Ensure Medical Affairs activities meet applicable regulatory requirements, quality management standards, and sponsor expectations. Oversee standard operating procedures, quality plans, corrective and preventive action plans, audits, and inspection responses while monitoring evolving global regulatory requirements. Technology and process innovation: Evaluate opportunities to improve Medical Monitoring and Pharmacovigilance through technology, automation, and AI-assisted solutions, including enhanced case processing, signal detection, and literature monitoring. People leadership and organizational development: Lead, mentor, and develop a multidisciplinary team and its functional leaders. Establish workforce planning, performance indicators, career development, succession planning, and leadership development initiatives while fostering an inclusive, accountable, and high-performing culture. Cross-functional collaboration: Work closely with Clinical Operations, Data Management, Biostatistics, Regulatory Affairs, Quality Assurance, Scientific Affairs, and Business Development to support integrated program delivery and consistent quality standards. Requirements Medical qualifications: Medical degree (MD, DO, or equivalent international qualification) is required. Board certification in dermatology or rheumatology is an advantage, although a strong generalist physician background is also welcome. An MBA or other advanced business qualification is considered an asset. Professional experience: 12–15 years of progressive experience in the pharmaceutical, biopharmaceutical, or clinical research industry, including 5–7 years in a leadership position within a contract research organization (CRO), pharmaceutical company, or comparable organization. Functional expertise: Demonstrated experience leading and scaling Medical Monitoring and Pharmacovigilance functions, with a strong understanding of global clinical trial regulations, patient safety requirements, and quality standards across multiple therapeutic areas. Commercial and financial capabilities: Proven experience engaging clients in revenue-generating environments, contributing to business development, and managing budgets or profit-and-loss responsibilities. The ability to develop competitive service pricing and align resources with financial objectives is important. Regulatory and quality experience: Experience working with health authorities, supporting regulatory inspections, managing audits, and defending compliance findings. Familiarity with global pharmacovigilance obligations and clinical research regulatory frameworks is essential. Executive leadership: A demonstrated ability to lead multidisciplinary teams, develop functional strategies, manage organizational change, and build a culture of scientific excellence, accountability, and continuous improvement. Communication and relationship management: Strong executive presence, scientific credibility, and the ability to communicate complex medical and safety matters clearly to sponsors, senior leaders, regulators, and internal teams. Preferred qualifications: Experience establishing or scaling a Medical Affairs function, familiarity with pharmacovigilance safety databases and reporting automation tools, and exposure to AI-assisted medical monitoring, pharmacovigilance, or medical writing workflows. Peer-reviewed publications, scientific conference presentations, multilingual capabilities, and international regulatory experience are additional assets. Working style and availability: Comfortable operating in a fast-paced, growth-oriented global environment, collaborating across functions and geographies, and traveling frequently as required. Candidates must be legally authorized to work in North America. Benefits Competitive compensation: Attractive executive-level compensation with performance-based incentives. Comprehensive benefits: Access to a full benefits package supporting employee well-being. Remote flexibility: Remote work arrangements available across North America. International exposure: Opportunities to collaborate with global teams, pharmaceutical sponsors, and clinical research professionals across multiple regions. Strategic influence: Direct participation in executive-level decision-making, business growth initiatives, and organizational strategy. Professional development: Opportunities to shape and expand Medical Affairs capabilities, explore emerging technologies, and contribute to scientific and operational innovation. Collaborative environment: A growth-oriented workplace that values collaboration, innovation, reliability, responsiveness, and high-quality delivery. Meaningful impact: The opportunity to influence patient safety, clinical trial integrity, and the quality of medical research across diverse therapeutic areas.