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Associate Director/Director Clinical Scientist

Company: CARGO-Therapeutics
Location: San Mateo
Posted on: January 22, 2023

Job Description:

ABOUT CARGO -CARGO Therapeutics, formerly Syncopation Life Sciences, is advancing a new generation of adoptive cell therapies for cancers. Our cell therapies focus on addressing the primary mechanisms of failure, or resistance and relapse, to the currently available Chimeric Antigen Receptor T-cell (CAR T) therapies. Despite the advances made by existing autologous CAR T therapies, these treatments are only curative for less than half of all cancer patients, and therapeutic failure, resistance, and relapse are common. In addition, far too many patients are unable to access these -potentially curative therapies due to barriers, including manufacturing, supply, -time, -and reimbursement challenges.CARGO is actively working to address these barriers with novel solutions that address the problems of resistance and access. Through smarter science, CARGO is developing and delivering CAR T-cell therapies to cure more patients. Focused on the delivery of complex therapeutic cargo, we enable the -multiplex -engineering necessary to overcome multiple mechanisms of tumor resistance, to counter inhibition by solid tumors, and in the allogeneic setting to evade immune rejection. -From research to manufacturing to clinical care, we at CARGO aspire to disrupt the status quo to overcome resistance and maximize access to -curative therapeutics.Join us to help make a difference.Position Summary -Reporting to the Vice President, Head of Clinical Development, CARGO is seeking an Associate Director/Director, Clinical Scientist, who will be Clinical Development Responsible for Phase 1-3 study working with a medical monitor. -The successful candidate will have a good clinical science experience in clinical trials and ensures cross-functional integration, coordination, and alignment to enable effective and efficient CDP execution, including regular review and analysis of protocol violations, authoring of study start-up documents, partnering with Data Management for case report form (CRF) design and instructions for use, review of all study documents requiring clinical expertise as identified by the Execution Team, and communication of milestone timelines to enable preparation of high-quality data summaries to support regulatory and clinical documentation and/or team deliverables. -From a technical standpoint, the ideal candidate has experience with recruitment and retention practices, clinical trial diversity practices, a strong interest in process improvement projects, and cross-functional initiative leadership, along with skills in metrics and dashboard creation and use of innovative technology to reduce the burden for sites, vendors, and staff alike. -Within the role, the candidate is expected to show and have advanced knowledge and experience in the following competencies: - - Decision Making, Strategic Thinking, and Problem Solving - - Influence and Collaboration - - Agility and Proactivity -With advanced technical competencies in the following areas: - - Drug Development and Study Design - - Study Management and Execution - - Vendor Management and Oversight -The role is based in San Mateo, CA but may also be suitable for a hybrid or remote work arrangement. -What You'll Do at CARGO -Clinical Trial Planning and Management. More specifically as follows: -

  • Trains study site personnel on protocol execution -
  • Contributes to clinical documentation of study execution including management of regulated documents, notes of clinical decisions, and study conduct that are considered permanent record -
  • Authors and/or reviews the clinical sections of any regulatory documents supporting clinical trials in collaboration with the Medical Monitor and Medical Writer -
  • In consultation with the Medical Monitor, be the primary point of contact to address or properly triage inquiries from site, CRO personnel, and site monitors regarding the study protocol, informed consent, and patient-specific questions. - - -
  • Responsible for the review, finalization, and update of information/data entered into clinical trials registry (clinicaltrials.gov) -
  • Participates in the development of the CDP, as needed -
  • Assists with Clinical Science due diligence activities for in-licensing and development opportunities -
  • Partners with Data Management to develop electronic CRF and instructions for their use, the Data Quality Review Plan, and resolution of all clinical queries to sites -
  • May participate in Health Authority interactions, as well as interactions with site IRBs/Ethics Committees and/or review committees -
  • Contributes to scientific abstracts for submission to national and international scientific conferences and to publications for peer-reviewed journals -
  • Collaborates with biostatistics to develop and QC data tables, listings, and figures and develops data-driven study-specific analyses, as appropriate -
  • Collaborates with Safety Science to identify and track any potential safety events within a given trial and/or across trials for assigned program(s) -
  • Conducts medical data reviews -
  • Provides Clinical Science input to proposed revisions of SOPs and Guidance documents -The Right Stuff -
    • Advanced clinical/science degree or equivalent required (PharmD, PhD, MSN, MPH, etc.) -
    • Four years of clinical scientist experience, or an equivalent combination of education and experience -
    • Experience working in complex matrixed setting(s) -
    • Experience authoring full clinical trial protocols and/or study results and conclusions -
    • In-depth understanding of Phase I-III drug development -
    • Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance -
    • Comprehensive understanding of product and safety profiles -
    • Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant guidelines and regulations -
    • Strong computer skills -
    • Proven history of independently performing Clinical Science responsibilities -
    • Impeccable ethics and outstanding attention to detail -
    • Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target, and high-quality manner within budget guidance -
    • Excellent interpersonal, verbal communication, and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally -
    • Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points -
    • Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results -Preferred Experience -
      • Publishing clinical trial results in peer-reviewed journals -
      • Two or more years of experience working in the field of oncology -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 requirements 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, and it applies regardless of whether the position is located at a CARGO 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. -

Keywords: CARGO-Therapeutics, San Mateo , Associate Director/Director Clinical Scientist, Executive , San Mateo, California

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