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FirstString Research is a clinical stage biotechnology company founded on a vision to deliver clinically relevant and effective solutions for inflammation-based medical conditions through an understanding of the molecular and cellular contexts that define the underlying pathology. Our focus is on diseases with unmet medical needs associated with dysregulation of inflammatory processes and an impaired injury response.

FirstString is a high growth, fast paced organization that offers competitive salary and benefits including 401k and stock options to employees at all levels. We are currently seeking highly motivated, self-driven individuals to join our team. The ability to be productive and successful in an intense work environment is critical.

Head of Discovery

The Head of Discovery will be responsible for conducting a full range of activities required to conceptualize, prepare, submit, and manage grant proposals and regulatory documents to foundation, government and corporate sources. Responsibilities include exploring and sourcing new funding opportunities, producing high quality written scientific documents for funding applications and publication, including writing, editing, and proofreading grant proposals, scientific manuscripts for peer review, white papers, protocols, commercialization plans, and regulatory documents; as well as overseeing successfully funded projects.

Job Duties:

  • Proactively identify foundation and government funding opportunities.
  • Identify fit between company’s technical capabilities and priorities and granting agencies’ research needs.
  • Perform literature/product searches on new ideas to understand and assess novel advancements as they relate to FirstString’s product roadmap.
  • Work closely with staff in developing and transforming ideas into grant proposals.
  • Establish and maintain collaborative relationships with scientists in academic and private institutions.
  • Oversee and report on progress of successfully funded projects.
  • Maintain comprehensive and up to date knowledge of platform technological advances and particular market areas involved in identifying and soliciting grants.
  • Manage deadlines and deliverables and keep all involved parties on schedule.
  • Draft high quality written grant applications.
  • Assist with assembling scientific documents as necessary (e.g., institutional grants, annual/occasional reports, progress reports for grants admin., etc.).
  • All other duties as required.

Qualifications:

  • Ph.D. in Biology, biochemistry, other life science, or relevant background; postdoctoral fellows; Assistant/Associate Professor level.
  • Proven experience in writing grants, including NIH R01 proposals, SBIRs, STTRs and/or experience with IND applications and clinical protocols preferred.
  • Exceptional verbal and written English language communications skills.
  • Ability to problem-solve, think objectively, act proactively.
  • Ability to handle changing priorities and multiple deadlines while maintaining high quality of workmanship.

 

Clinical Trial Manager
Duties include operational management and oversight assistance of clinical trial activities for assigned studies. The Clinical Trial Manager will be responsible for execution of clinical activities at the project level and will work closely with and report to the Director of Clinical Programs.

Job Duties:

  • Co-manage operational activities of clinical trials including training, monitoring, trial timeline, budget, resources, and vendors.
  • Monitoring and reporting of study progress including site activation, target enrollment, site visits, etc.
  • Ensure clinical operations deliverables are being met per study timeline.
  • Assist with sponsor study start up process activities including but not limited to attendance at the trial kick-off meeting, assist with clinical site orientations, site selection and review of site and vendor Clinical Trial Agreements and budgets.
  • Prepare project plans, standard operating procedures, and other clinical documents.
  • Assist with preparation of site visit reports.
  • Monitor the quality of vendor deliverables.
  • Co-monitoring to ensure compliance with study protocol, SOPs, and ICH/GCP regulations.
  • Oversee investigational product inventory and reconciliation.
  • Clinical data review and validation to source records.
  • Coordination of site visits and investigator meetings.
  • Manage vendor invoices in collaboration with accounting teams; reconcile with study budget.
  • Assist with quality assurance audits and reporting.
  • TMF maintenance and archiving – ensure all project level study documentation is filed in the TMF in accordance with company SOPs and regulatory requirements.
  • Provide timely, comprehensive updates and reports on all duties to Director of Clinical Programs.
  • Other duties as assigned.

Qualifications:

  • Bachelor’s or Master’s Degree in Life Science discipline (or relevant field)
  • Clinical operations experience in the Pharmaceutical, Biotechnology, Academic or contract research organization (CRO) setting
  • Clinical project management experience in early and late phase trials (Phase I-III)
  • Must have familiarity with clinical research concepts, practices, FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
  • Exceptional verbal and written English language communications skills.
  • Ability to travel domestically and internationally.

Please send a resume and cover letter to info@firststringresearch.com