Assistant Director, Clinical Research Methodology (US/EU)

Location: North Carolina, United States

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Requisition Number: 2263

Position Title: Assistant Director, Clinical Research Methodology

External Description:

The Assistant Director for Translational Research Activities within Worldwide is responsible for working across the Scientific Affairs, operational, and business development functions within the organization to build alliances and deliver services which exemplify the ability to link medical and scientific expertise with operational acumen.

The position is located within the “late phase” business component of Worldwide Clinical Trials, with direct reporting lineage into the Chief Medical and Scientific Officer of the organization. This is both a “hands on” and strategic role that involves working with internal study teams, subject matter experts and technical leads to develop sound scientific content for producing manuscripts, posters, blogs and presentations, clinical development programs, with particular emphases upon clinical trial synopses and protocols. Responsibilities include actively participating and presenting at relevant industry events and organizations including bid defense meetings as appropriate to support Worldwide products and services.
 
RESPONSIBILITIES:
Tasks may include but are not limited to:

  • Review and analyze published studies and related databases, journals, guidance of regulatory agencies and scientific organization news releases to understand its impact on Worldwide and its customers and feedback to the Scientific, Medical, and Operational and Business Development aspects of the organization.
  • Incorporate new developments from global regulatory agencies and recognized industry trends that could impact clinical trial methodology, particularly in the transition from animal research into clinical studies.
  • Participate as speaker at conferences, as a contributing author of scientific manuscripts/posters and blogs to illustrate Worldwide’s leadership in clinical trial methodology and operational implementation.
  • Contribute to generation of presentation and educational materials for other professionals within Worldwide to exhibit our thought leadership.
  • Work with Scientific Communications within Worldwide marketing to coordinate and maintain the scientific review process.
  • Identify opportunities for external and internal collaborations across functions to advance scientific insight, as it will impact delivery of services.
  • Provide subject matter expertise, when appropriate, on various issues within Worldwide and assure best practice awareness.

 
 
OTHER SKILLS AND ABILITIES:

  • Content expertise in basic science is a prerequisite with an ability to translate that experience into testable hypotheses in the context of a clinical protocol.
  • Facility in biostatistics, applicable to clinical research
  • Superb technical writing skills, with an ability to link concepts across both design, operational, and biostatistical concepts
  • Works independently, with minimal professional guidance
  • Represents an emerging professional talent which is anticipated to mature with increasing sophistication given the scope of research demands presented by clinical research organizations
  • Ability to multi-task, strong interpersonal skills and results oriented
  • Excellent computer skills involving documents and slide presentations

REQUIREMENTS:

  • Doctorate level (PhD) with research experience and publications indicating an ability to think critically, creatively, to formulate testable hypotheses, and methods of testing in the clinical trial setting.
  • A Graduate degree in related to chemistry, biology, biochemistry, pharmacology or related basic science discipline.
  • Eligible for postdoctoral training in clinical trial methodology, or has already completed such a training program.
  • Facility with public speaking and technical writing.

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City:

State: North Carolina

Employment Type: Regular

Community / Marketing Title: Assistant Director, Clinical Research Methodology (US/EU)

Company Profile:

We’re a global, mid-size CRO that pushes boundaries, innovates and invents — because the path to a cure for the world’s most persist diseases is not paved by those who play it safe, but by those who take pioneering, creative approaches, and implement them with quality and excellence. We are experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs, in the best possible way.

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We only accept resumes from staffing organizations with pre-approved contractual agreements. Please do not forward resumes directly to our hiring managers, jobs alias, or any other company location. Unsolicited resumes from employment agencies will not be considered and Worldwide is not responsible for any fees related to unsolicited resumes.