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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 small 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.

Director of Clinical Programs

Duties will include management and oversight of all aspects of clinical trial activities for assigned studies. The Director of Clinical Programs is accountable for achieving successful delivery of clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.

Job Duties:

  • Manage and oversee operational aspects of clinical trials; including oversight of clinical teams, management of trial timelines, budgets, resources and vendors.
  • Monitor and provide updates on trial progress with respect to target enrollment, budget and timeline management, as well as quality standards and risk mitigation.
  • Lead sponsor study startup process, including but not limited to conduct of the trial kick-off meeting, clinical site orientations, the set-up of trial master file (TMF), site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
  • Ensure effective and comprehensive project plans and procedures are in place and operational at each clinical site and work proactively with clinical trial teams to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
  • Lead clinical trial team working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in the Trial Master File in a timely manner.
  • Organize and lead regular meetings with the Data and Safety Monitoring Board(s).
  • Review and approve site visit reports; ensure tracking, follow up and resolution of site issues have been completed in a timely manner.
  • Oversee data validation to source records and the resolution of any discrepancies.
  • Monitor the quality of clinical team and/or vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team.
  • Review and approve invoices in collaboration with the accounting team to ensure investigator payments occur in a timely manner.
  • Review and approve quality assurance audit reports for appropriateness, timeliness and accordance with company SOPs and regulatory requirements.
  • Ensure all project level study documentation is filed in the TMF in accordance with company SOPs/all regulatory requirements and provide oversight to the clinical team regarding TMF filing, maintenance and archival procedures.
  • Effectively provide support to Clinical Research Associates/Managers in the conduct of the trials.
  • Other duties as assigned.

Qualifications:

  • M.D., Ph.D., or Master’s Degree in Life Science discipline (or relevant field) or Bachelors degree with compensating experience.
  • Clinical operations experience in the Pharmaceutical, Biotechnology, Academic or contract research organization (CRO) setting.
  • Clinical project management experience with 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

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.

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