Director Clinical Development and Operations (ADX-117-19)

| Greater Boulder Area | Hybrid
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Director of Clinical Development and Operations (ADX-117-19)

 

COMPANY:

 

ArcherDX, headquartered in Boulder, CO, is committed to the advancement of personalized medicine by making next-generation sequencing technology more reliable and accessible. We seek like-minded individuals who share our values of curiosity, passion and grit to meet these goals.

 

Make it happen by joining us in the fight against cancer.

 

POSITION SUMMARY:

 

Residing in our Boulder, CO office, the Director of Clinical Development and Operations is responsible for ensuring that the company’s clinical studies are initiated, implemented and completed in a timely, organized, scientific, and ethical manner. The ideal candidate will provide leadership and program oversight to plan and conduct high-quality clinical trials in accordance with FDA and international GCP regulations. Additionally, this position will be responsible for the development of clinical systems/processes and effective communication with internal and external clients. 

 

RESPONSIBILITIES:

 

  • Manage all operational aspects of clinical development projects
  • Manage staff of 4-5, going up to 7-8 with growth
  • Responsible and accountable for the conduct of clinical trials
  • Oversee, lead and manage cross-functional team resources and external service providers or partners to conduct trials on time, on budget, in compliance, and of highest quality
  • Coordinate/execute all operational aspects of clinical studies
  • Work collaboratively with cross-functional internal and external teams including assay development, regulatory affairs, medical writing and biostatistics
  • Identify, qualify, audit, and manage all external vendors, including CROs
  • Take initiative to continually monitor each external vendor in performance management, escalate issues where appropriate, and make the appropriate changes in order to ensure trial conduct is completed in compliance and meets the company’s business objectives
  • Ensure clinical trial team and clinical trial sites are properly trained and in compliance with company and/or CRO SOPs, CFR/EMA regulations, ICH GCP guidance, and study protocol
  • Identify any gaps in company/CRO SOPs and develop internal SOPs as needed
  • Performs site monitoring with the field team, as needed
  • Facilitates all start-up activities including but not limited to investigational site contracts, investigational site, and ethics committee submissions
  • Facilitate confidentiality agreements, negotiate study agreements and budgets with sites and external vendors
  • Responsible for writing, reviewing, and/or approving clinical project deliverables such as scope definition documents, investigational product labeling/kitting, manuals, informed consent, IRB submissions/approvals, site activations, monitoring plan tools, and close-out plans
  • Provides regular updates to the management team, vendors and contract staff concerning status and progress of the trial
  • Proactively monitors and reports trial progress and performance, timelines, and financial metrics on an ongoing basis to the management team, including current status of study milestones and forecast budgetary requirements based on the scope of work
  • Review, understanding, and compliance with privacy and security of protected health information including HIPAA, ICH, GDPR, and HGRAC
  • Ability to travel up to 25% of the time

 

 

REQUIREMENTS:

 

  • 8-10 years of clinical experience in the biotech/pharmaceutical industry
  • Strong background in clinical trial design and proven track record of timely and efficient execution of clinical programs in an industry setting
  • 5 years supervisory/leadership experience
  • Thorough knowledge of ICH/GCP guidelines is required.
  • Experience with IVD clinical studies is a plus
  • Experience working with Contract Research Labs is a plus
  • Med-tech and sample bank experience helpful
  • Demonstrated ability to analyze, interpret and present complex clinical and scientific data
  • Ability to effectively work individually, within a multi-disciplinary team and with external vendors and clinicians
  • Excellent interpersonal communication and presentations skills with a proficiency in presenting clinical and non-clinical data to internal and external audiences
  • Thorough understanding of US healthcare environment, clinical research process, FDA and other federal/international regulations and ethical guidelines

 

KEY ATTRIBUTES:

 

  • Drive and determination
  • Ability to work in a fast-paced and dynamic environment
  • Ability to participate with others as a member of the team to ensure that demanding and difficult projects are handled smoothly and cooperatively to enhance the success of the projects and maintain strong relationships within all parts of the company.
  • Strong communication and presentation skills
  • Self-starter
    • Driven to perform
    • Self-directed: needs little explicit direction
    • Able to organize, prioritize, and delegate tasks to efficiently move projects forward

 

EDUCATION:

 

  • BS/BA in science/health-related field, MS or Ph.D. is preferred

 

 

 

 

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Location

Conveniently located minutes from downtown Boulder via Pearl Street or the Goose Creek Path. Easily commutable from all directions.

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