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    Vice President, Head of Translational Medicine - San Carlos, United States - Cargo Therapeutics

    Cargo Therapeutics
    Cargo Therapeutics San Carlos, United States

    3 weeks ago

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    Job Description

    Job DescriptionCARGO Therapeutics is a pioneering clinical stage biotechnology company dedicated to revolutionizing cell therapy. We are leveraging innovative technologies with a commitment to advancing therapeutic outcomes for a wider patient population while fostering a culture where individuals can thrive both personally and professionally. The Vice President, Head of Translational Medicine will play a pivotal role in advancing CARGO's mission by leading clinical pharmacology and discovery biomarker efforts for our cell therapy programs. You will be responsible for overseeing the generation and analysis of clinical pharmacology and exploratory biomarker data obtained from both registrational and exploratory cell therapy clinical trials and will aid in guiding strategic decision-making to drive successful clinical development of CARGO's investigational cellular therapy products. This role will be responsible for leading a multidisciplinary team of scientists and operational experts, providing strategic direction, mentorship, and support to foster a culture of collaboration, innovation, and excellence. You will also work closely with Clinical Development, Technical Operations, and Project Teams to ensure seamless integration of translational activities into clinical trial protocols and to ensure program execution. The role requires interaction with a broad range of stakeholders, both internal and external partners including academic research centers, CROs, CDMOs, scientific and clinical advisory board members. Representation of CARGO through presentations and other interactions at scientific conferences, investor events, and industry consortia is required. The candidate will be a key member of CARGO's Senior Leadership Team. Furthermore, you will spearhead the development of innovative assays and data analysis strategies to advance how we assess response to CARGO's investigational products in patients, driving towards more personalized and effective treatments to overcome resistance to the current class of approved cellular therapy products. The role can be Remote or located at Headquarters in San Carlos, CA. WHAT YOU'LL DO AT CARGO THERAPEUTICS
    • Leadership: Provide strategic direction and leadership for the Translational Medicine Team (translational scientists, biomarker experts, bioassay & bioanalytical scientists, pharmacologists, and computational biologists), fostering a culture of collaboration, innovation, and excellence.
    • Strategy: Develop a translational strategy across programs to support the clinical development of cell therapy product candidates, ensuring alignment with overall corporate goals.
    • Clinical pharmacology and exploratory biomarker oversight: Oversee the design, execution, and analysis of studies, utilizing state-of-the-art methodologies and technologies.
    • Operationalize the Translational Medicine function at CARGO: Through close collaboration with operations teams, external vendors and diagnostics partners (e.g., to define/deliver study-specific plans, data generation, and data transfer agreements).
    • IND and BLA support: Work closely with cross-functional teams to support the preparation of data for Investigational New Drug (IND) and Biologics License Applications (BLAs) submissions, leveraging expertise in regulatory requirements.
      • Contribute subject matter expertise to regulatory submissions and serve as the Company's biomarker/IVD representative for interactions with regulatory agencies.
    • Support data analysis, storage, and decision making: Collaborate to provide insights into mechanism of action, patient stratification, safety and treatment response, guiding clinical development decisions. Implement processes to ensure the highest standards of data integrity, data management, sample traceability, and statistical analyses.
    • Aid in corporate risk management: Identify potential risks and challenges related to clinical translational activities and develop mitigation strategies to ensure successful execution of clinical programs.
    • Scientific expertise/innovation: Stay abreast of the latest developments in cell therapy, translational medicine, and regulatory landscape, incorporating relevant insights into program strategies. Seek to develop new assays and methods for assessing biomarker and clinical pharmacology to further our understanding of cell therapy outcomes.
    • Budgeting: Ensure financial resources are effectively allocated and managed to support achievement of the priority objectives.
    THE RIGHT STUFF: Required Experience & Qualifications
    • Advanced degree (MD or PhD) in the Life Sciences field with 15+ years' industry experience, or an equivalent combination of education and experience
    • Proven expertise in cell therapy
    • Experience in bringing cell and gene therapy drug candidates from pre-IND through PI/II and, ideally, to BLA preferred
    • First-hand knowledge of and experience with assays relevant for cell therapies including flow cytometry, IHC, qPCR, anti-therapeutic antibody assessment, T-cell antigen specific response assays (ELISPOT, flow based, tetramer, etc.), and serum cytokine quantification
    • Thorough knowledge of ICH, GCP, GLP guidelines to ensure ethical and compliant conduct of clinical studies in U.S., Europe, and RoW; experience with regulatory inspections and audits is preferred
    • Working knowledge of statistical methods and models for data analysis
    • Experience in working with computational data scientists
    • Proven history of building relationships and fostering engagement across stakeholders, including the senior management, scientific and clinical advisory boards, academic and biopharma partners, and CROs
    • Proven experience partnering with drug discovery to identify and develop candidates by continuous integration of learnings from correlative clinical data and exploratory biomarker studies to define next generation products
    • Sound business acumen with a pragmatic, collegial, results-oriented leadership style that can translate innovation, creative strategies, and conceptual thinking into plans.
    • Excellent leadership and management skills to inspire, coach, mentor, and develop a strong team
    PAY RANGE The combined pay range for this role is $250,000 - $345,000. Title and salary will be based on our assessment of skills and experience relevant to our needs for the role. ABOUT CARGO THERAPEUTICS CARGO Therapeutics, Inc. is a clinical-stage biotechnology company positioned to advance next generation, potentially curative cell therapies for cancer patients. CARGO's programs, platform technologies, and manufacturing strategy are designed to directly address the limitations of approved cell therapies, including limited durability of effect, safety concerns and unreliable supply. CARGO is currently evaluating its lead program, CRG-022, an autologous CD22 chimeric antigen receptor (CAR) T-cell therapy candidate, in a potentially pivotal Phase 2 clinical trial in patients with large B-cell lymphoma (LBCL) whose disease relapsed or was refractory (R/R) to CD19 CAR T-cell therapy. CARGO also plans to evaluate CRG-022 in patients at earlier stages of disease, including LBCL and other hematologic malignancies. Beyond its lead program, CARGO is leveraging its proprietary cell engineering platform technologies to develop a pipeline of programs that incorporate multiple transgene therapeutic "cargo" designed to enhance CAR T-cell persistence and trafficking to tumor lesions, as well as to help safeguard against tumor resistance and T-cell exhaustion. CARGO's founders are pioneers and world-class experts in CAR T-cell therapy, and its team has significant experience and success developing, manufacturing, launching and commercializing oncology and cell therapy products. For more information, please visit the CARGO Therapeutics website at https://cargo- Join us to help make a difference EEO & EMPLOYMENT ELIGIBILITY CARGO Therapeutics, Inc. is committed to building a diverse, equitable, and inclusive company. We provide equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status. CARGO Therapeutics, Inc. also complies with all applicable national, state, and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification required of applicable law. CARGO Therapeutics requires all new hires to be fully vaccinated against COVID-19 as of their start date. This requirement is a condition of employment at CARGO Therapeutics, and it applies regardless of whether the position is located at a CARGO Therapeutics site or is fully remote. If you are unable to receive the vaccine due to a disability or serious medical condition, or because it is prohibited because of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.
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