NantHealth
Clinical Regulatory Pharmacist | CSSIFM
NantHealth, El Segundo, California, United States, 90245
Location: El Segundo, CA
Job Type: Full-Time
Industry: Pharmaceuticals / Healthcare / Clinical Research
NantWorks (the "Company") is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow's opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries.
Link to Privacy:
https://privacy.nant.com/
About Us
Chan Soon-Shiong Institute for Medicine (CSSIFM) is a state-of-the-art outpatient cancer care center in El Segundo with a dedicated team committed to personalized patient care. We provide both standard-of-care oncology treatments and serve as a Phase 1/2 clinical research site for innovative immuno-oncology therapies. Our research portfolio features cutting-edge investigational products such as natural killer (NK) cell therapies and the IL-15 superagonist Anktiva® (N-803), which selectively stimulates NK and T effector cells without activating suppressor T cells. These novel approaches - often combined for synergy - have yielded promising results, including complete responses in difficult-to-treat cancers like Merkel cell carcinoma, advanced pancreatic cancer, and triple-negative breast cancer.
Currentactive trials at our El Segundo clinic include a Phase 2 study ("Maya," NCT06710288) combining autologous memory-enriched NK cell therapy with N-803 in recurrent ovarian cancer , and a Phase 1 trial (QUILT 3.100, NCT05976828) evaluating a novel immunotherapy (IBRX-042) in patients with HPV-associated head & neck tumors. By joining CSSIFM, you will be at the forefront of immuno-oncology research and patient care, working with a team that values innovation, patient safety, and regulatory excellence.
Position Summary
We are seeking a detail-oriented Clinical Regulatory Pharmacist to ensure our oncology pharmacy operations and clinical trials meet the highest standards of regulatory compliance and quality. In this pivotal role, you will oversee the regulatory aspects of investigational drug use and clinical research at our site, from preparing FDA submissions to managing on-site pharmacy trial activities. You will collaborate with cross-functional teams to guide Phase 1/2 trials through development and approval processes, ensuring strict adherence to Good Clinical Practice (GCP) guidelines and all applicable regulations. This position blends clinical pharmacy expertise with regulatory affairs, requiring hands-on experience with investigational products and a deep understanding of oncology trial protocols.
Key Responsibilities • Regulatory Guidance: Provide expert guidance on clinical trial design, investigational drug development, and regulatory approval pathways for new oncology therapies. Ensure early-phase trial protocols align with regulatory standards and scientific objectives. • Regulatory Submissions: Prepare, review, and submit high-quality regulatory documents and filings (e.g. INDs, CTAs, NDAs, amendments) for investigational products. Coordinate with sponsors and investigators to compile data and ensure timely submissions. • Compliance Oversight: Ensure that all clinical trial activities and pharmacy operations remain in full compliance with FDA, ICH, and other relevant international regulations. Maintain inspection readiness by adhering to 21 CFR Part 312 and ICH-GCP guidelines for investigational drug management. • Investigational Product Management: Oversee the handling of investigational products (IP) on-site, including proper receipt, storage, compounding/preparation, dispensing, and documentation of novel biologics (e.g. cell therapy products, IL-15 superagonists). Maintain strict IP accountability and accurate records of inventory, usage, and final disposition in accordance with study protocols . • Protocol Adherence: Monitor daily pharmacy activities for ongoing trials to ensure protocol compliance. Verify that investigational drugs are dispensed and administered exactly as outlined in the clinical trial protocol, with all dosing, labeling, and documentation meeting GCP and protocol requirements. • Audit & Inspection Support: Act as the pharmacy regulatory lead during audits and inspections by regulatory authorities or sponsors. Proactively identify and address compliance issues, and prepare all required documentation (accountability logs, temperature logs, deviation reports, etc.) for inspections. • Cross-Functional Collaboration: Collaborate closely with principal investigators, clinical research coordinators, the Quality Assurance team, and Pharmacovigilance staff to support trial operations. Establish pharmacy procedures for each study (e.g. drug dispensing workflows, compounding instructions, billing for study drugs) in partnership with study teams . Provide training and guidance to pharmacists and nurses on investigational agent preparation and handling. • Regulatory Intelligence: Stay up-to-date with changes in regulatory requirements and oncology drug development guidelines. Interpret new FDA/EMA regulations or ICH guidance and communicate their implications to the research and pharmacy teams. Update internal SOPs and processes accordingly to maintain best practices. • Pharmacovigilance & Safety: Work with the safety/pharmacovigilance department to ensure timely reporting of adverse drug reactions and safety findings from trials. Review investigational drug safety data and ensure appropriate risk mitigation strategies are in place as per regulatory standards.
Qualifications • Education & Licensure: Licensed Pharmacist (PharmD or equivalent) in good standing. Advanced training or certification in clinical research or regulatory affairs is a plus. • Experience: Minimum 5 years of experience in a clinical pharmacy, regulatory affairs, or pharmaceutical research setting (oncology experience preferred). Demonstrated experience with investigational drug trials or regulatory submission processes is highly desirable. • Regulatory Knowledge: In-depth knowledge of drug development pathways and regulatory approval processes (IND, NDA, etc.), as well as strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and FDA regulations governing clinical trials . • Clinical Trial Acumen: Understanding of clinical trial conduct and protocol requirements, particularly in Phase 1 and 2 oncology studies. Ability to interpret clinical protocols and ensure pharmacy compliance with complex study procedures. • Skills: Excellent attention to detail and organizational skills to manage documentation and multiple studies. Strong communication and interpersonal skills to work effectively with investigators, clinicians, and regulatory authorities. Proficiency in writing and reviewing technical documents. • Certification: RAC (Regulatory Affairs Certification) or Board Certification in Oncology Pharmacy (BCOP) is a plus, but not required.
Preferred Qualifications • Experience preparing electronic Common Technical Document (eCTD) submissions and using regulatory submission software tools. • Prior involvement in filing clinical trial applications and managing the lifecycle of investigational products through approval. • Familiarity with handling advanced immunotherapies or cell therapy products in a clinical trial setting. Experience in an Investigational Drug Service (IDS) pharmacy or similar clinical research pharmacy role is advantageous. • Ability to develop or refine Standard Operating Procedures (SOPs) related to investigational product handling, dispensing, and accountability in compliance with GCP.
The Pay Range
$86.50 - $96.15 Per Hour
Pay Range Statement
This is the pay range the Company reasonably expects to pay for this position at the time of this posting. Compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position.
What We Offer • Competitive Compensation: A competitive salary commensurate with experience, along with a comprehensive benefits package (health, dental, vision, 401k, etc.). • Work-Life Balance: Flexible work environment with potential hybrid/remote work options. We support our employees in maintaining a healthy work-life balance while meeting the needs of our clinic and research operations. • Professional Growth: Opportunities for professional development, continuing education, and attending industry conferences. You will work on groundbreaking trials and innovations in oncology, enhancing your expertise in both clinical and regulatory domains. • Collaborative Culture: A supportive, collaborative team environment that values innovation, excellence, and patient-centered care. You will be part of a multidisciplinary team driven by the goal of advancing cancer treatment and improving patient outcomes.
Join us at CSSIFM and contribute to pioneering immuno-oncology research while ensuring the highest standards of pharmacy practice and regulatory compliance. Apply today to become a key player in our mission to change the paradigm of cancer care through innovative science and compassionate care.
Chan Soon-Shiong Institute for Medicine is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or any other protected status. www.cssifm.org
Application Process: Please submit your résumé/CV and a cover letter detailing your relevant experience and interest in this position. Qualified candidates will be contacted for interviews. We look forward to hearing from you and potentially welcoming you to our team at CSSIFM in El Segundo!
Contact: For any inquiries about the position, please email us at careers@cssifm.org or call 213-266-5600.
Closing Date: Applications will be reviewed on a rolling basis until the position is filled.
Job Type: Full-Time
Industry: Pharmaceuticals / Healthcare / Clinical Research
NantWorks (the "Company") is the parent company of various private and public entities that are changing how we work, live and play. We focus on three main categories: life sciences; energy & renewables; and media & technology. We invest in strategies that improve our core capabilities and in brand new industries, poised to change mankind for the better. By capturing tomorrow's opportunities through scientific processes and entrepreneurial philosophies, we are at the forefront of emerging high-growth technologies across a wide range of industries.
Link to Privacy:
https://privacy.nant.com/
About Us
Chan Soon-Shiong Institute for Medicine (CSSIFM) is a state-of-the-art outpatient cancer care center in El Segundo with a dedicated team committed to personalized patient care. We provide both standard-of-care oncology treatments and serve as a Phase 1/2 clinical research site for innovative immuno-oncology therapies. Our research portfolio features cutting-edge investigational products such as natural killer (NK) cell therapies and the IL-15 superagonist Anktiva® (N-803), which selectively stimulates NK and T effector cells without activating suppressor T cells. These novel approaches - often combined for synergy - have yielded promising results, including complete responses in difficult-to-treat cancers like Merkel cell carcinoma, advanced pancreatic cancer, and triple-negative breast cancer.
Currentactive trials at our El Segundo clinic include a Phase 2 study ("Maya," NCT06710288) combining autologous memory-enriched NK cell therapy with N-803 in recurrent ovarian cancer , and a Phase 1 trial (QUILT 3.100, NCT05976828) evaluating a novel immunotherapy (IBRX-042) in patients with HPV-associated head & neck tumors. By joining CSSIFM, you will be at the forefront of immuno-oncology research and patient care, working with a team that values innovation, patient safety, and regulatory excellence.
Position Summary
We are seeking a detail-oriented Clinical Regulatory Pharmacist to ensure our oncology pharmacy operations and clinical trials meet the highest standards of regulatory compliance and quality. In this pivotal role, you will oversee the regulatory aspects of investigational drug use and clinical research at our site, from preparing FDA submissions to managing on-site pharmacy trial activities. You will collaborate with cross-functional teams to guide Phase 1/2 trials through development and approval processes, ensuring strict adherence to Good Clinical Practice (GCP) guidelines and all applicable regulations. This position blends clinical pharmacy expertise with regulatory affairs, requiring hands-on experience with investigational products and a deep understanding of oncology trial protocols.
Key Responsibilities • Regulatory Guidance: Provide expert guidance on clinical trial design, investigational drug development, and regulatory approval pathways for new oncology therapies. Ensure early-phase trial protocols align with regulatory standards and scientific objectives. • Regulatory Submissions: Prepare, review, and submit high-quality regulatory documents and filings (e.g. INDs, CTAs, NDAs, amendments) for investigational products. Coordinate with sponsors and investigators to compile data and ensure timely submissions. • Compliance Oversight: Ensure that all clinical trial activities and pharmacy operations remain in full compliance with FDA, ICH, and other relevant international regulations. Maintain inspection readiness by adhering to 21 CFR Part 312 and ICH-GCP guidelines for investigational drug management. • Investigational Product Management: Oversee the handling of investigational products (IP) on-site, including proper receipt, storage, compounding/preparation, dispensing, and documentation of novel biologics (e.g. cell therapy products, IL-15 superagonists). Maintain strict IP accountability and accurate records of inventory, usage, and final disposition in accordance with study protocols . • Protocol Adherence: Monitor daily pharmacy activities for ongoing trials to ensure protocol compliance. Verify that investigational drugs are dispensed and administered exactly as outlined in the clinical trial protocol, with all dosing, labeling, and documentation meeting GCP and protocol requirements. • Audit & Inspection Support: Act as the pharmacy regulatory lead during audits and inspections by regulatory authorities or sponsors. Proactively identify and address compliance issues, and prepare all required documentation (accountability logs, temperature logs, deviation reports, etc.) for inspections. • Cross-Functional Collaboration: Collaborate closely with principal investigators, clinical research coordinators, the Quality Assurance team, and Pharmacovigilance staff to support trial operations. Establish pharmacy procedures for each study (e.g. drug dispensing workflows, compounding instructions, billing for study drugs) in partnership with study teams . Provide training and guidance to pharmacists and nurses on investigational agent preparation and handling. • Regulatory Intelligence: Stay up-to-date with changes in regulatory requirements and oncology drug development guidelines. Interpret new FDA/EMA regulations or ICH guidance and communicate their implications to the research and pharmacy teams. Update internal SOPs and processes accordingly to maintain best practices. • Pharmacovigilance & Safety: Work with the safety/pharmacovigilance department to ensure timely reporting of adverse drug reactions and safety findings from trials. Review investigational drug safety data and ensure appropriate risk mitigation strategies are in place as per regulatory standards.
Qualifications • Education & Licensure: Licensed Pharmacist (PharmD or equivalent) in good standing. Advanced training or certification in clinical research or regulatory affairs is a plus. • Experience: Minimum 5 years of experience in a clinical pharmacy, regulatory affairs, or pharmaceutical research setting (oncology experience preferred). Demonstrated experience with investigational drug trials or regulatory submission processes is highly desirable. • Regulatory Knowledge: In-depth knowledge of drug development pathways and regulatory approval processes (IND, NDA, etc.), as well as strong familiarity with Good Clinical Practice (GCP), ICH guidelines, and FDA regulations governing clinical trials . • Clinical Trial Acumen: Understanding of clinical trial conduct and protocol requirements, particularly in Phase 1 and 2 oncology studies. Ability to interpret clinical protocols and ensure pharmacy compliance with complex study procedures. • Skills: Excellent attention to detail and organizational skills to manage documentation and multiple studies. Strong communication and interpersonal skills to work effectively with investigators, clinicians, and regulatory authorities. Proficiency in writing and reviewing technical documents. • Certification: RAC (Regulatory Affairs Certification) or Board Certification in Oncology Pharmacy (BCOP) is a plus, but not required.
Preferred Qualifications • Experience preparing electronic Common Technical Document (eCTD) submissions and using regulatory submission software tools. • Prior involvement in filing clinical trial applications and managing the lifecycle of investigational products through approval. • Familiarity with handling advanced immunotherapies or cell therapy products in a clinical trial setting. Experience in an Investigational Drug Service (IDS) pharmacy or similar clinical research pharmacy role is advantageous. • Ability to develop or refine Standard Operating Procedures (SOPs) related to investigational product handling, dispensing, and accountability in compliance with GCP.
The Pay Range
$86.50 - $96.15 Per Hour
Pay Range Statement
This is the pay range the Company reasonably expects to pay for this position at the time of this posting. Compensation will be determined based on the skills, qualifications, and experience of the applicant along with the requirements of the position.
What We Offer • Competitive Compensation: A competitive salary commensurate with experience, along with a comprehensive benefits package (health, dental, vision, 401k, etc.). • Work-Life Balance: Flexible work environment with potential hybrid/remote work options. We support our employees in maintaining a healthy work-life balance while meeting the needs of our clinic and research operations. • Professional Growth: Opportunities for professional development, continuing education, and attending industry conferences. You will work on groundbreaking trials and innovations in oncology, enhancing your expertise in both clinical and regulatory domains. • Collaborative Culture: A supportive, collaborative team environment that values innovation, excellence, and patient-centered care. You will be part of a multidisciplinary team driven by the goal of advancing cancer treatment and improving patient outcomes.
Join us at CSSIFM and contribute to pioneering immuno-oncology research while ensuring the highest standards of pharmacy practice and regulatory compliance. Apply today to become a key player in our mission to change the paradigm of cancer care through innovative science and compassionate care.
Chan Soon-Shiong Institute for Medicine is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or any other protected status. www.cssifm.org
Application Process: Please submit your résumé/CV and a cover letter detailing your relevant experience and interest in this position. Qualified candidates will be contacted for interviews. We look forward to hearing from you and potentially welcoming you to our team at CSSIFM in El Segundo!
Contact: For any inquiries about the position, please email us at careers@cssifm.org or call 213-266-5600.
Closing Date: Applications will be reviewed on a rolling basis until the position is filled.