Vice President, Medical Affairs, Clinical Operations & Regulatory Affairs

Dendreon Pharmaceuticals•Seal Beach, CA

17h•Onsite

About The Position

Dendreon is seeking a senior leader to provide strategic oversight across Medical Affairs, Clinical Operations, and Regulatory Affairs. The role aligns clinical development, regulatory strategy, and commercial objectives while supporting the development and lifecycle management of the company’s oncology and immunotherapy products. It requires on-site presence at the Seal Beach, California location and up to 30% domestic and international travel. The position leads Medical Affairs activities, including scientific communications, KOL and investigator relationships, medical review, evidence generation, and post-marketing clinical activities. It also oversees clinical trial planning and execution, clinical operations teams and vendors, study budgets and timelines, compliance, and continuous improvement. In Regulatory Affairs, the role develops global regulatory strategies, leads regulatory submissions and agency interactions, and advises leadership on regulatory requirements and risks. As a member of the senior leadership team, the role contributes to corporate strategy and organizational growth. It manages and develops Regulatory Affairs and Clinical Operations personnel, establishes departmental objectives and budgets, fosters cross-functional collaboration, and presents program and strategy updates to executive management, board members, and external stakeholders.

Requirements

Advanced degree required: MS, PharmD, PhD, MD, or equivalent scientific discipline.
At least 15 years of progressive leadership experience in biotechnology, pharmaceuticals, cell therapy, oncology, immunotherapy, or related life sciences industries.
At least 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.
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.
Ability to operate effectively in a highly regulated biotechnology or pharmaceutical environment.
Must work on-site at the Seal Beach, California location.
Up to 30% domestic and international travel is required.
Regularly sit, stand, walk, and use hands to operate a computer keyboard, mouse, and mobile phone.

Nice To Haves

Medical degree preferred but not required.
Additional business or leadership training preferred.
Previous executive or senior leadership experience preferred.

Responsibilities

Provide strategic oversight of Medical Affairs activities and align them with clinical development, regulatory strategy, and commercial objectives.
Partner with Commercial leadership on scientifically accurate and compliant product and pipeline communications.
Build strategic relationships with physicians, investigators, KOLs, healthcare providers, and scientific experts.
Support scientific and medical content development and review, including publications, congress presentations, medical education materials, and field medical resources.
Oversee medical review of promotional and non-promotional materials for scientific accuracy and regulatory compliance.
Support investigator-sponsored studies, real-world evidence initiatives, and post-marketing clinical activities.
Provide medical and scientific leadership for regulatory submissions, advisory boards, and agency interactions; collect and communicate medical insights.
Oversee planning, execution, monitoring, and reporting of clinical trials and lead Clinical Operations teams, CROs, vendors, and study partners.
Develop clinical operational strategies and oversee study timelines, budgets, resource allocation, and risk management.
Ensure clinical studies comply with GCP, ICH guidelines, protocols, and applicable regulations.
Collaborate with Medical Affairs, Regulatory Affairs, Quality, Biostatistics, Data Management, and Pharmacovigilance.
Monitor study performance and implement corrective actions; support site selection, study startup, enrollment, closeout, inspection readiness, audits, and inspections.
Drive continuous improvement in clinical operational efficiency and study execution.
Develop and execute global regulatory strategies for product development, clinical studies, manufacturing changes, and commercialization.
Lead preparation, submission, and maintenance of regulatory filings, including INDs, BLAs, amendments, supplements, and annual reports.
Serve as primary liaison with the FDA and international health authorities; lead agency interactions, meetings, inspections, audits, and responses to inquiries.
Advise executives, project teams, and functional departments on regulatory strategy, requirements, and risks; monitor regulatory changes and assess business impact.
Support due diligence, licensing, partnerships, and strategic business initiatives; establish regulatory policies, procedures, and best practices.
Oversee regulatory intelligence and communicate emerging trends to leadership.
Serve on the senior leadership team and contribute to corporate strategy and organizational growth initiatives.
Manage Regulatory Affairs and Clinical Operations personnel, including hiring, performance management, coaching, succession planning, and organizational development.
Build and mentor high-performing teams; establish departmental objectives, budgets, KPIs, and long-term strategic plans.
Foster collaboration across Research, Development, Manufacturing, Quality, Medical Affairs, Commercial, and Executive Leadership.
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 compliance, accountability, innovation, and operational excellence.
Partner with Pharmacovigilance and Quality on product safety communications and risk management activities.