FirstString Research

Senior Director of Clinical Operations

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Job Description

The Senior Director of Clinical Operations will be a key leader in strategic planning, oversight, and operational management of FirstString Research’s clinical trial portfolio. The Senior Director of Clinical Operations will work across multiple functions to ensure operational trial deliverables are completed according to established timelines, budget, operational procedures, quality standards, and in compliance with applicable ICH/GCP regulations. This includes developing and overseeing clinical operational plans aligned with corporate strategy and R&D objectives; close communication and collaboration with contract research organizations (CROs), clinical sites, and/or vendors; study budget management; trial timeline management; development of clinical trial designs with insight from key opinion leaders; and quality assurance of clinical data. The Senior Director of Clinical Operations will provide oversight and strategic guidance to FirstString’s clinical operations team and will work closely and collaboratively with other senior and functional leaders to ensure harmonized and integrated development strategies to drive portfolio prioritization.

Ideal candidates have a background in the biotechnology/pharmaceutical industry, with strong leadership skills and a proactive drive to develop and improve consistent project management excellence to achieve clinical trial deliverables.

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

Key Essential Functions:

  • Organize and oversee activities of FirstString’s clinical operations staff and vendors/service providers involved in the conduct of assigned clinical trials
  • Proactively identify hurdles or challenges in study conduct/management and provide efficient, innovative solutions and mitigation strategies in collaboration with Executive/Senior Management
  • Lead the development and contribute to the preparation of relevant study documentation including clinical protocols, operational study plans, statistical analysis plan, clinical study reports, etc. Review and refine clinical operational plans as needed.
  • Lead and oversee CROs and external vendors to conduct clinical trials at the highest quality and within established timelines and budgets
  • Communicate project objectives and deliverables with clinical sites and CROs
  • Maintain regular contact with CROs and external vendors to assess performance and provide guidance as needed
  • Develop and manage study timelines (including recruitment)
  • Identify talent and resource gaps – responsible for performance management of clinical operations staff
  • Oversee FDA regulatory submissions

Qualifications:

  • Bachelor’s degree or advanced degree in health sciences or related discipline. Advanced degree is desirable.
  • Minimum of 10 years relevant clinical research experience in biotechnology/ pharmaceutical industry or CRO. Background in biotechnology or pharmaceutical industry preferred, but not required.
  • Minimum of 5 years upper level management and relevant supervisory experience
  • Strong experience in vendor management, leading CROs/contracted resources, site monitoring, clinical quality compliance, and managing clinical trial budgets
  • Demonstrated experience in clinical operations development and strategic planning, as well as experience in early to late-stage clinical trials
  • In-depth knowledge of the drug development process (IND to NDA), including FDA regulations and expectations
  • Excellent working knowledge of clinical SOPs, GCP, and ICH guidelines
  • Demonstrated ability to successfully manage multiple projects with equal priority
  • Well-honed leadership and organizational skills, capable of leading by example, thrive on increasing levels of responsibility, proactively and confidently moves the business forward, sense of urgency to meet pressing deadlines in a fast-paced environment, uses insightful and critical thinking to optimize operational management of clinical trials
  • Dedicated team player, displays positive attitude, directly contributes to team efforts, and builds strong relationships with a wide range of stakeholders, both internally and externally, at all levels (e.g. Executive/Senior management, KOLs, CRO team members, cross-functional team members, etc.)
  • Detail and quality oriented with demonstrated track record of successfully meeting project deliverables within established deadlines, budget, and allocated resources

Tagged as: biopharmacuetical, clinical operations

Job Summary

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Charleston, SC Location
Full Time Job Type
FirstString Research

Contacts

300 West Coleman Blvd. Suite 203, Mount Pleasant, SC 29464

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