Vice President, Medical Affairs (Clinical Operations & Regulatory Affairs)

Job Summary

This role ensures alignment across scientific communications, product lifecycle management, clinical development, and regulatory strategy to support the successful development, approval, and commercialization of the company’s products and contract manufacturing services (CMS) pipeline. The Vice President serves as a key member of the senior leadership team and works cross-functionally with Quality, Manufacturing, Commercial, Finance, and Executive Leadership to advance corporate objectives while ensuring compliance with applicable regulatory and industry standards.

Key Responsibilities

Medical Affairs Leadership (50%)

• Provide strategic oversight of Medical Affairs activities to ensure alignment between clinical development, regulatory strategy, and commercial objectives.
• Partner with Commercial leadership to ensure scientifically accurate and compliant communication regarding company products and pipeline programs.
• Develop and maintain strategic relationships with physicians, investigators, Key Opinion Leaders (KOLs), healthcare providers, and scientific experts to support clinical development, evidence generation, product adoption, and medical education initiatives.
• Support development and review of scientific and medical content, including publications, congress presentations, medical education materials, and field medical resources.
• Oversee medical review of promotional and non-promotional materials to ensure scientific accuracy and regulatory compliance.
• Collaborate with Key Opinion Leaders (KOLs), investigators, and external scientific experts to support product development and lifecycle management.
• Support investigator-sponsored studies (ISS), real-world evidence initiatives, and post-marketing clinical activities.
• Provide medical and scientific leadership during regulatory submissions, advisory board meetings, and agency interactions.
• Ensure appropriate collection and communication of medical insights from healthcare providers and clinical stakeholders.
• Partner with Pharmacovigilance and Quality teams regarding product safety communications and risk management activities.

Clinical Operations Leadership (30%)

• Provide strategic oversight for the planning, execution, monitoring, and reporting of clinical trials.
• Lead Clinical Operations teams, CROs, vendors, and study partners to ensure successful delivery of clinical programs.
• Develop and implement clinical operational strategies that align with regulatory and corporate objectives.
• Oversee study timelines, budgets, resource allocation, and risk management activities.
• Ensure clinical studies are conducted in compliance with GCP, ICH guidelines, protocol requirements, and applicable regulations.
• Collaborate with Medical Affairs, Regulatory Affairs, Quality, Biostatistics, Data Management, and Pharmacovigilance functions.
• Monitor study performance metrics and implement corrective actions when necessary.
• Support clinical site selection, startup activities, enrollment strategies, and study closeout activities.
• Ensure inspection of readiness and support regulatory inspections and audits.
• Drive continuous improvement initiatives to enhance operational efficiency and study execution.

Regulatory Affairs Leadership (20%)

• Develop and execute global regulatory strategies supporting product development, clinical studies, manufacturing changes, and commercialization initiatives.
• Lead preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, amendments, supplements, annual reports, and other regulatory submissions.
• Serve as the primary liaison with regulatory agencies, including the U.S. Food and Drug Administration and international health authorities.
• Provide regulatory guidance and risk assessments to executive leadership, project teams, and functional departments.
• Ensure compliance with applicable regulations, guidance documents, and industry standards.
• Monitor evolving regulatory requirements and assess business impact.
• Lead regulatory interactions, meetings, inspections, audits, and responses to agency inquiries.
• Support due diligence activities, licensing opportunities, partnerships, and strategic business initiatives.
• Establish and maintain regulatory policies, procedures, and best practices.
• Oversee regulatory intelligence activities and communicate emerging trends to leadership.

Executive Leadership Responsibilities

• Serve as a member of the senior leadership team, contributing to corporate strategy and organizational growth initiatives.
• Directly and indirectly manages Regulatory Affairs and Clinical Operations personnel, including directors, managers, individual contributors, consultants, and external service providers. Responsible for hiring, performance management, coaching, succession planning, and organizational development.
• Build, develop, and mentor high-performing Regulatory Affairs and Clinical Operations teams.
• Establish departmental objectives, budgets, KPIs, and long-term strategic plans.
• Foster strong cross-functional collaboration across Research, Development, Manufacturing, Quality, Medical Affairs, Commercial, and Executive Leadership teams.
• Present program updates, regulatory strategies, and clinical development plans to executive management, board members, and external stakeholders.
• Manage departmental budgets and external vendor relationships.
• Promote a culture of compliance, accountability, innovation, and operational excellence.

Job Requirements

• Advanced degree required (MS, PharmD, PhD, MD, or equivalent scientific discipline).
• Medical degree preferred but not required.
• Additional business or leadership training preferred.
• Minimum 15 years of progressive leadership experience within biotechnology, pharmaceutical, cell therapy, oncology, immunotherapy, or related life sciences industries.
• Minimum 10 years of experience leading Regulatory Affairs functions.
• Significant experience overseeing Clinical Operations and clinical trial execution.
• Experience managing Medical Affairs activities, scientific communications, and KOL engagement.
• Demonstrated success leading regulatory submissions and agency interactions.
• Experience supporting products through development, approval, commercialization, and lifecycle management.
• Previous executive or senior leadership experience preferred.
• Expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and applicable global regulatory requirements.
• Strong understanding of clinical development, clinical trial operations, and evidence generation.
• Comprehensive knowledge of Medical Affairs functions, publication strategy, and scientific communications.
• Exceptional leadership, organizational, and strategic planning skills.
• Strong presentation, negotiation, and stakeholder management capabilities.
• Proven ability to influence across multiple functions and executive leadership levels.
• Experience managing external vendors, CROs, consultants, and scientific advisory boards.
• Demonstrated ability to operate effectively in a highly regulated biotechnology or pharmaceutical environment.