Vice President, Data Sciences

Reporting to the Chief Medical Officer, CARGO Therapeutics is hiring a Vice President, Data Sciences to build and lead the Biostatistics, Statistical Programming and Clinical Data Management functions to support our cell therapy portfolio. This leader will work closely with the Chief Medical Officer (CMO), the Head of Translational Medicine, Head of Manufacturing Science & Technology (MS&T) and Process Sciences in Technical Operations and other members of the Clinical Leadership Team (CLT) and Executive Team to provide strategic direction, design, and analysis of clinical and translational studies for the evaluation, interpretation and preparation of study results. In addition, this leader is expected to establish the data architecture and processes to enable rapid analysis of pharmacokinetic/pharmacodynamic and manufacturing attributes that may impact safety and efficacy.

The successful candidate will also establish and maintain close working relationships with internal and external partners to help ensure that program development teams have strategic input and technical expertise on statistical methodologies for clinical studies.

The role is based in San Carlos, CA but is also suitable for a hybrid or remote work arrangement.

WHAT YOU'LL DO AT CARGO THERAPEUTICS

The Vice President, Data Sciences will lead a group of biostatisticians, statistical programmers, clinical data management, and data analyst professionals who develop, implement, and execute across the following broad areas of responsibility:

• Drive and provide critical guidance and input into the design of clinical studies and assembly of clinical trial protocols and statistical analysis plans for clinical trials, as well as for key sections of license applications (e.g., Summary of Clinical Efficacy)

• Oversee the biostatistical analysis of clinical trials

• Provide strategic guidance in the preparation of Regulatory Authority documents such as clinical study reports, submissions, clinical protocols, aggregate safety, and clinical pharmacology reports

• Ensure the interpretation of accurate and scientifically credible clinical and scientific data obtained from our clinical trials is appropriately presented internally and to Health Authorities and healthcare providers

• Provide statistical support and expertise to internal cross functional teams to generate study reports, posters, publications, and data/results dossiers for submission to regulatory authorities

• Identify risks to trial design and reporting and develop solution-orientated approaches to address or mitigate risk

• Partner closely with Translational Medicine Group and Technical Operations to build the appropriate data architecture and analytics that will enable rapid analysis of manufacturing characteristics to support real-time data requests related to OOS trends and non-conforming product investigations

• Partner closely with the Clinical Development and Translational Medicine teams to enable nimble analysis of data related to information requests related to toxicity/efficacy on pivotal and future studies of CARGO's investigational cell therapy products

• Partner closely with Translational Medicine Group and Technical Operations to develop the appropriate workflows and mechanisms for data transfer from external vendors, with an emphasis on data integrity

THE RIGHT STUFF: Required Experience & Qualifications

• PhD or MS in statistics or biostatistics with 15+ years of experience in the pharmaceutical and/or biotechnology industry and at least 8 years of direct management experience

• Broad and extensive knowledge of theoretical and applied statistics

• Expert in the principles and techniques of data analysis and interpretation necessary for global registrational filings (e.g. development of Clinical Study Reports, integrated summaries, etc.)

• Extensive regulatory experience with gaining approvals of NDAs, MAAs, BLAs

• Experience with breakthrough designation, RMAT, Sakigake, PRIME, orphan designation and companion diagnostic submissions (IDE/PMA) is highly desirable

• Proven experience in building and managing a high performing team in a dynamic environment; recruitment, motivation and empowerment by leading and collaborating with cross-functionality and efficient delegation

• Expert level experience with SAS and/or other statistical software packages

• Expert level proficiency with CDISC standards including SDTM, ADaM and CDASH data standards

• Demonstrated ability to establish relationships with internal colleagues and external collaborators and represent the company in public settings

• Proficient with GCP/ICH/FDA requirements, clinical trial design and strategies

• Must have a results-oriented work ethic and a positive, can-do attitude

• Proven track record of working with cross functional teams and external vendors/partners

• The ideal candidate will be capable working in a "hands on" and "roll-up sleeves" capacity when required or providing oversight and guidance depending on the circumstances

• Must be willing and available for periodic travel (domestic US and internationally) as required

PAY RANGE

The pay range for this role is $260,000 - $358,000. 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-tx.com/.

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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.