Vice President, Regulatory Affairs / Clinical Operations / Medical Affairs

4w4 weeks ago

Dendreon

Seal Beach, US · Full-time · $280,000 – $360,000

About this role

At Dendreon, we're transforming the battle against cancer with personalized immunotherapy. Our flagship product, PROVENGE (sipuleucel-T), was the first FDA-approved immunotherapy for metastatic castrate-resistant prostate cancer. As Vice President of Regulatory Affairs, Clinical Operations & Medical Affairs, you will provide strategic leadership and oversight across these three critical functions.

You will develop and execute global regulatory strategies, lead clinical trial planning and execution, and oversee scientific communications and product lifecycle management. This role ensures alignment across clinical development, regulatory strategy, and commercialization to support the successful development and approval of our products.

Serving as a key member of the senior leadership team, you will work cross-functionally with Quality, Manufacturing, Commercial, Finance, and Executive Leadership to advance corporate objectives while ensuring compliance with regulatory and industry standards. You will be the primary liaison with regulatory agencies, including the FDA and international health authorities.

This role offers the opportunity to drive meaningful impact on cancer patients' lives while leading high-performing teams in an innovative, patient-focused environment. Dendreon's culture is rooted in putting patients first, acting with integrity, building trust, raising the bar, and driving results.

Requirements

Proven executive-level experience leading Regulatory Affairs, Clinical Operations, and Medical Affairs functions in the pharmaceutical or biotechnology industry
Deep knowledge of FDA regulations, global regulatory requirements, and drug development lifecycle, particularly for oncology or immunotherapy products
Experience leading successful BLA/NDA submissions and managing interactions with regulatory agencies
Demonstrated ability to lead clinical trial strategy, including oversight of CROs and study vendors
Strong cross-functional leadership skills, with experience collaborating with Quality, Manufacturing, Commercial, and Finance teams
Ability to serve as a strategic advisor to executive leadership on regulatory and clinical matters
Experience managing regulatory inspections, audits, and responses to agency inquiries

Responsibilities

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 submissions
Serve as the primary liaison with regulatory agencies including the FDA and international health authorities
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
Provide regulatory guidance and risk assessments to executive leadership, project teams, and functional departments
Lead regulatory interactions, meetings, inspections, audits, and responses to agency inquiries
Establish and maintain regulatory policies, procedures, and best practices across the organization

Benefits

Opportunity to work on a first-in-class immunotherapy that transforms the battle against cancer
Leadership role in an innovative, patient-focused biopharmaceutical company
Collaborative culture grounded in core values: Put Patients First, Act with Integrity, Build Trust, Raise the Bar, Drive Results
On-site presence at Seal Beach, CA location with a minimum 4-day-per-week work schedule
Be part of a highly skilled team at the forefront of cancer treatment innovation