Manager, Clinical Immunology

Dendreon Pharmaceuticals LLC•Seal Beach, CA

1d•Onsite

About The Position

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, utilizing a patient’s own immune cells to fight the disease. If you’re driven by the opportunity to make a meaningful impact on cancer patients’ lives, we invite you to join our team. With Immunotherapy Manufacturing Facilities in Seal Beach, CA, and Union City, GA, a talented team of scientific, clinical, regulatory, and corporate professionals based in Seal Beach, and a commercial organization operating across the United States, Dendreon continues to advance innovation in personalized cancer treatment. The Manager, Clinical Immunology leads the planning, execution, and interpretation of clinical immunology and biomarker activities supporting Dendreon's oncology and cellular immunotherapy development programs. This role serves as the subject matter expert for immune monitoring, translational research, biomarker strategy, and immunogenicity assessments across clinical studies. The position collaborates closely with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Research & Development, Quality, and external partners to generate insights that support product development, regulatory submissions, and scientific advancement of Dendreon's immunotherapy platform.

Requirements

PhD in Immunology, Cell Biology, Molecular Biology, Oncology, Translational Medicine, or related scientific discipline.
5-8+ years of industry, academic, or clinical research experience in biotechnology, pharmaceutical, cell therapy, immunotherapy, or oncology environments.
Minimum 3 years of experience supporting clinical development programs and translational research initiatives.
Prior people leadership, project leadership, or matrix management experience.
Strong experience with immune monitoring and biomarker technologies including flow cytometry, immunophenotyping, ELISPOT, cytokine analysis, molecular biomarker platforms, and related immunological assays.
Experience supporting clinical studies and working with clinical samples, biomarker data, and translational endpoints.
Knowledge of oncology, tumor immunology, cellular immunotherapies, cancer vaccines, or related therapeutic areas.
Strong understanding of GCP, GLP, biomarker development principles, and regulatory expectations.
Demonstrated ability to analyze, interpret, and communicate complex scientific data.
Excellent collaboration, project management, communication, and organizational skills.

Nice To Haves

Postdoctoral training in Immunology, Oncology, Translational Medicine, or a related discipline.
Experience supporting cellular immunotherapy, autologous cell therapy, cancer vaccine, or other advanced therapy programs.
Experience with immunogenicity assessments, immune correlates of response, and biomarker-driven development strategies.
Experience managing CROs, central laboratories, and external research partnerships.
Experience supporting regulatory interactions and submissions involving biomarker or translational data.
Familiarity with statistical methods and biomarker data visualization tools.

Responsibilities

Serve as the Clinical Immunology subject matter expert supporting Dendreon's oncology and cellular immunotherapy clinical development programs.
Lead clinical immunology, biomarker, immune monitoring, and immunogenicity strategies to support study objectives and development decisions.
Design, oversee, and interpret immunological and biomarker analyses, including flow cytometry, immunophenotyping, ELISPOT, cytokine profiling, and other translational research methodologies.
Collaborate with Clinical Development, Clinical Operations, Medical Affairs, Regulatory Affairs, Biometrics, Research & Development, and Quality teams to ensure successful execution of clinical studies.
Provide scientific oversight of external laboratories, CROs, academic collaborators, and biomarker partners, including vendor selection, performance monitoring, and deliverable review.
Support protocol development, statistical analysis plans, clinical study reports, publications, regulatory submissions, and responses to health authority inquiries.
Evaluate emerging immunology and biomarker technologies and translate scientific findings into actionable development strategies.
Present scientific data and recommendations to study teams, senior leadership, investigators, and external stakeholders.
Ensure activities are conducted in compliance with GCP, GLP, applicable regulations, and company procedures, while supporting inspection and audit readiness.
Mentor junior scientists and contribute to scientific leadership across development programs as needed.
Perform additional duties as assigned.