Chief Medical Affairs, Clinical Ops & Regulatory Leader

Dendreon; Seal Beach (CA); On-site; USD 256,000 - 294,000; Full time

Job summary

Dendreon seeks an experienced Regulatory Affairs and Clinical Operations leader to guide global regulatory strategies, submissions, and lifecycle management. The role collaborates with Medical Affairs, Quality, and Commercial teams to ensure compliance and strategic execution across development programs.

Executive leadership responsibilities include steering regulatory policy, managing budgets and external partners, and advancing lifecycle management for immunotherapy products.

Qualifications

• 15+ years of progressive leadership experience in biotechnology/pharma/life sciences.
• 10+ years leading Regulatory Affairs functions.
• Experience overseeing Clinical Operations and trial execution.
• Experience managing Medical Affairs activities, publications, and KOL engagement.
• Regulatory submissions, agency interactions, and lifecycle management expertise.

Responsibilities

• Provide strategic oversight of Medical Affairs activities to align development, regulatory strategy, and commercial objectives.
• Lead Clinical Operations teams, CROs, vendors, and study partners to deliver clinical programs.
• Develop and implement regulatory strategies for development, changes, and commercialization.
• Ensure compliance with FDA regulations, ICH guidelines, GCP, GMP across programs.
• Support due diligence, licensing opportunities, partnerships, and executive communications.
• Foster cross-functional collaboration and manage budgets, timelines, and resources.

Skills

Leadership

Regulatory affairs

Strategic planning

Stakeholder management

Education

MS/PharmD/PhD/MD or equivalent

Medical degree preferred

Job description

Dendreon seeks an experienced Regulatory Affairs and Clinical Operations leader to guide global regulatory strategies, submissions, and lifecycle management. The role collaborates with Medical Affairs, Quality, and Commercial teams to ensure compliance and strategic execution across development programs.

Executive leadership responsibilities include steering regulatory policy, managing budgets and external partners, and advancing lifecycle management for immunotherapy products.