VP/Director, Clinical Operations - Relocation Assistance may be provided - Job # 2331

Additional Information
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale is currently recruiting for the following Raleigh-Durham based position.

Essential Duties and Responsibilities:

Reporting to the Chief Medical and Development Officer, the Vice President of Clinical Operations will have primary responsibility for overseeing the conduct of the clinical trials for the company’s drug candidates. Serve as company clinical expert in investigator, medical advisory and regulatory meetings. Contribute to the set-up of clinical studies, including creating protocols, case report forms, investigator brochures and other study start-up documents. Provide daily guidance to the clinical operations team and take ownership of the interaction with external CRO's.

Responsibilities include, but are not limited to:

  • Work with clinical investigators to execute clinical programs/studies according to GCP.
  • Orchestrate meetings to determine best clinical path forward for a clinical program.
  • Develop study outlines, protocols, amendments and investigator brochures.
  • Work with statistics to plan data analysis.
  • Interpret, analyze, and write/produce clinical research medical reports and other documents.
  • Author briefing booklets, contribute to drug safety board charters, clinical sections of regulatory submissions and presentation slide data for internal and investor use.
  • Partner with department managers to trouble shoot study protocol issues as they arise and provide clinical response to questions from investigators, site coordinators, health authorities and institutional review boards.
  • Author draft scientific publications from clinical study data and on investigational products or safety questions.
  • Review clinical SOPs and contribute to clinical department process improvements.
  • Participate in meetings with FDA or other regulators and work with the VP, Regulatory Affairs on the documentation submission process to regulators.
  • Conduct, participate in and provide status updates to internal project teams to ensure development strategies are continually valid and on track.
  • Oversee serious adverse event process; coding/medication/patient history.

Qualifications/Education/Experience:

  • Medical Degree and board certification with a minimum of ten years of relevant experience in clinical research, preferably in the areas of critical care and/or hepatology.
  • Proven successful management of teams and projects.
  • Superior verbal and written communication skills with specific proven expertise in medical writing, including protocol development, clinical sections for regulatory filings and investigator brochures.

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