Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs

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 tria Lead Clinical Operations teams, CROs, vendors, and study partners to ensure successful delivery of clinical progra Develop and implement clinical operational strategies that align with regulatory and corporate objectiv Oversee study timelines, budgets, resource allocation, and risk management activiti Ensure clinical studies are conducted in compliance with GCP, ICH guidelines, protocol requirements, and applicable regulatio Collaborate with Medical Affairs, Regulatory Affairs, Quality, Biostatistics, Data Management, and Pharmacovigilance functio Monitor study performance metrics and implement corrective actions when necessa Support clinical site selection, startup activities, enrollment strategies, and study closeout activiti Ensure inspection of readiness and support regulatory inspections and audi Drive continuous improvement initiatives to enhance operational efficiency and study executi Regulatory Affairs Leadership (2 Develop and execute global regulatory strategies supporting product development, clinical studies, manufacturing changes, and commercialization initiat Lead preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, amendments, supplements, annual reports, and other regulatory submiss Serve as the primary liaison with regulatory agencies, including the U.S. Food and Drug Administration and international health authori Provide regulatory guidance and risk assessments to executive leadership, project teams, and functional departm Ensure compliance with applicable regulations, guidance documents, and industry stand Monitor evolving regulatory requirements and assess business im Lead regulatory interactions, meetings, inspections, audits, and responses to agency inqui Support due diligence activities, licensing opportunities, partnerships, and strategic business initiat Establish and maintain regulatory policies, procedures, and best pract Oversee regulatory intelligence activities and communicate emerging trends to leader Serve as a member of the senior leadership team, contributing to corporate strategy and organizational growth initi 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 organization de velopment.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 stakeh olders.Manage departmental budgets and external vendor relatio ships.Promote a culture of compliance, accountability, innovation, and operational exce rements:Advanced degree required (MS, PharmD, PhD, MD, or equivalent scientific dis cipline).Medical degree preferred but not required.Additional business or leadership training p referred.Minimum 15 years of progressive leadership experience within biotechnology, pharmaceutical, cell therapy, oncology, immunotherapy, or related life sciences in dustries.Minimum 10 years of experience leading Regulatory Affairs f unctions.Significant experience overseeing Clinical Operations and clinical trial e xecution.Experience managing Medical Affairs activities, scientific communications, and KOL en gagement.Demonstrated success leading regulatory submissions and agency inte ractions.Experience supporting products through development, approval, commercialization, and lifecycle ma nagement.Previous executive or senior leadership experience p referred.Expert knowledge of FDA regulations, ICH guidelines, GCP, GMP, and applicable global regulatory requ irements.Strong understanding of clinical development, clinical trial operations, and evidence ge neration.Comprehensive knowledge of Medical Affairs functions, publication strategy, and scientific commun ications.Exceptional leadership, organizational, and strategic plannin g skills.Strong presentation, negotiation, and stakeholder management capa bilities.Proven ability to influence across multiple functions and executive leadershi p levels.Experience managing external vendors, CROs, consultants, and scientific advisor y boards.Demonstrated ability to operate effectively in a highly regulated biotechnology or pharmaceutical env #J-18808-Ljbffr Planet Pharma