Associate Director, Clinical Science

Highly Competitive Salary
  1. Permanent
  2. Project/Study Manager (CSM/CPM)
  3. United States
Rockville, Maryland
Posting date: 08 May 2019
CR.MT.23206_1557327485

ProClinical, in support of our client, are seeking an individual to fill the role of Associate Director of Clinical Science, based in Rockville, MD.

Responsibilities

  • Author key clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR) as well as prepare strategy presentations, present and discuss data with governance, external consultants, KOLs and potentially within regulatory meetings in conjunction with members of the development team.
  • Create and/or review study documents/plans.
  • Proactively identify clinical development risks and propose risk mitigations.
  • Participate in the selection of sites, CROs, and vendors.
  • Analyze and synthesize clinical data for publication, conducting and evaluating clinical trials.
  • Supervise project team members in planning conducting and evaluating clinical trials.
  • Serve as medical monitor with significant responsibility for safety surveillance.
  • Key role in designing clinical development plans for assigned project.
  • Collaborate with R&D and other senior management in assessing requirements for emerging products, including next generation candidates.
  • Identify, select and train clinical research centers and investigators
  • Communicate internally and externally on clinical trial design and results.
  • Overseas planning and management of investigator meetings, advisory boards and other scientific committees as required by the protocol.

Skills and Qualifications

  • Advanced, doctoral level degree preferred. PhD, MD, MSc/MPH, PharmD, with 3-5 years of experience within a pharmaceutical company environment required
  • Knowledge of medical, scientific and clinical research techniques in the oncology and autoimmune therapeutic areas.

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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