Director, Clinical Development

Highly Competitive Salary
  1. Permanent
  2. Program Manager / Director
  3. United States
Boston, Massachusetts
Posting date: 07 Mar 2019
CR.MT.22128_1551990912

at ProClinical, we are seeking an individual to fill the role of Director of Clinical Development, based in Boston, MA.

Responsibilities

  • Design and execution of clinical development programs.
  • Oversee and manage the development and execution of clinical strategy.
  • Lead clinical protocol development.
  • Serve as the medical and safety monitor for rare disease and oncology studies.
  • Support the development and execution of clinical studies including the identification and management of collaborators, consultants, and/or Clinical Research Organizations (CROs).
  • Responsible for clinical sections of protocols, study procedure manuals, ICFs, INDs, Investigator Brochures and DSURs.
  • Participate in and contribute to regulatory meetings, including preparing briefing documents.
  • Oversee clinical study reporting, including data interpretation, and quality, accuracy and timeliness of clinical study reports and FDAAA registering and reporting.
  • Interface with key opinion leaders and manage scientific presentations at advisory boards, key scientific meetings and external committee meetings.
  • Works with external experts to present and publish clinical trial data.

Skills And Qualifications

  • MD or MD/PhD with experience in immuno-oncology and 5+ years of Clinical Trial and/or Translational Research experience.
  • Strong basic science and clinical research background in academia or industry.
  • Experience authoring, monitoring, analyzing, and reporting oncology clinical trials.
  • Experience in regulatory interactions including scientific advice, filing INDs and submissions
  • Excellent written, verbal, and interpersonal communication skills.
  • Strong record of high-quality peer-reviewed publications.
  • Strong working knowledge of GCP, EMA, and FDA policies.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Miles Tobin at (+1) 617-545-5922 or upload your resume on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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