Clinical data coordinator Jobs in Huntington Beach, CA

Manager, Clinical Immunology

Seal Beach, California, United States

WHO WE ARE:

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.

CORE VALUES:

• Put Patients First: Every day is an opportunity to improve the lives of those living with cancer.
• Act with Integrity: We commit to transparency, honesty, and always doing what's right.
• Build Trust: Trust is earned through candid, open communication and a collaborative approach.
• Raise the Bar: We embrace continuous improvement and innovation, always striving to elevate our people.
• Drive Results: We are accountable to each other and deliver success together.

Job Summary:

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.

Key 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.

Job Requirements:

Required Experience & Education:

• MS 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.

Preferred Experience & Education:

• PhD in Immunology, Cell Biology, Molecular Biology, Oncology, Translational Medicine, or related scientific discipline.
• 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.

Working Conditions and Physical Requirements:

• This role operates in a standard office setting using standard office equipment.
• Role requires frequent use of video conferencing, standard office software, and digital collaboration tools.
• Must have the ability to lift 10 20 lbs.
• Must have the ability to work in an office environment around laboratories, manufacturing areas and equipment with exposure to blood, blood products or OPIM (other potentially infectious materials) while donning required personal protective materials.

Dendreon is an equal employment and affirmative action employer F/M/Disability/Vet/Sexual Orientation/Gender Identity. The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

CA Compensation Range

$107,817 - $140,880 USD

Beware of Recruitment Scams

Please be aware of the potential for scams from individuals, organizations and internet sites that claim to represent Dendreon Pharmaceuticals in recruitment activities. We strongly recommend that you verify all communications you receive about positions at Dendreon. Any communications from Dendreon would come from an email address that ends in "@ dendreon.com ". Dendreon will never ask candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the recruitment or offer process. Dendreon conducts a formal recruitment process for all authorized positions posted and does not conduct interviews via social media, or other third-party sites or chat services. If you are unsure about a posting or email you receive, please contact us at AskHR@dendreon.com . If you believe you are a victim of fraud, please contact your local law enforcement.