Quality Recruiting. Established Experts.

Director Clinical Research, Pain

Reference Number: 2943
Location: NJ

Our client is a major global pharmaceutical and biotech company committed to improving health worldwide.  They have asked us to assist them in their search for a Director Clinical Research, Pain.

The Director Clinical Research, Pain will be responsible for the development and execution of clinical programs for a novel, new molecular biologic under development for the treatment of severe chronic pain.

Major tasks and responsibilities will include:

  • Assists in the development and execution of the overall clinical development strategy, study design, protocol development and execution of clinical studies.
  • Acts as a liaison between company and clinical investigators, develops credible relationships with opinion leaders, medical directors, and key regulatory officials.
  • Responsible for medical monitoring/reporting and company safety activities.
  • Evaluates adverse events (pre and post-marketing) for relationship to treatment.
  • Assists Regulatory Affairs in determining requirement for any corrective actions or health authority reporting.
  • Acts as medical contact for the Food and Drug Administration and other health authorities concerning clinical/medical issues.
  • Interprets, reports and prepares written and oral results of product research in preparation for regulatory submissions.
  • Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance.

We seek candidates with the following qualifications:

  • An MD/DO is preferred.  Training in neurology is a plus.  A PhD or PharmD will be considered with strong experience in drug analgesic development.
  • A minimum of 5 years of clinical research and development experience.
  • Experience in filing an NDA and experience in supervising and managing clinical research programs and staff is strongly preferred.
  • At least 2 years of pharmaceutical industry experience is required.
  • Will consider CRO or academically based experience with extensive involvement in clinical research and development.
  • Ability to work in a matrix environment with cross-functional teams is required.
  • Excellent oral, written and presentation skills are required.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 2943. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.