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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