Clinical Research Medical Director - Neurology

Highly Competitive
  1. Permanent
  2. Director, VP & Physician
  3. Poland
Warsaw
Posting date: 12 Jun 2019
ME.TR.23824c_1560351286

One of the largest CROS in the global market is currently recruiting a Clinical Research Medical Director - Neurology to one of their European teams on a home-based capacity. This contract research organisation (CRO) is renowned for their work in technological advances and access to real-world data. This is an exciting opportunity to become embedded in the wider clinical operations team and work on ground-breaking new medicine development.

Job Responsibilities:

  • Serving as Global Medical Advisor on assigned projects.
  • Serving as Scientific Advisor and providing guidance to Project Leaders on the medical and scientific aspects of assigned projects.
  • Providing medical support to investigative sites and project staff for protocol-related issues including protocol clarifications, inclusion/exclusion determinations, and issues of patient safety and/or eligibility.
  • Performing medical reviews of the protocol, Investigative Drug Brochure (IDB), and/or Case Report Forms (CRFs).
  • Providing therapeutic area/indication training for the project clinical team.
  • Attending and presenting at Investigator Meetings.
  • Performing reviews on and clarifying trial-related Adverse Events (AEs).
  • Performing medical case reviews of Serious Adverse Events (SAEs), including reviewing case documentation and patient narrative, in collaboration with the Pharmacovigilance department.
  • Providing medical support for the Analysis of Similar Events (AOSE), in collaboration with or on behalf of Pharmacovigilance department.
  • Performing medical review of adverse event coding.
  • Performing review of the Clinical Study Report (CSR) and patient narratives.
  • Attending Kick-Off meetings, weekly team meetings, and client meetings, as needed or requested.
  • Providing expert advice to the development of medically sounded delivery strategies for small to large and/or complex multi-region studies in partnership with sales and other functions responsible for business development activities.
  • Developing medically related aspects of client proposals, including the budget related to medical monitoring.
  • Providing medical and scientific advice to key internal stakeholders developing proposals; including, but not limited to, reviewing the protocol for scientific/regulatory soundness and feasibility, identifying target site and principal investigator profiles, anticipated patient recruitment, standard of care, and competitive landscape.
  • Attending and presenting at bid defence meetings, as required.
  • Participates in strategic business development activities including presentations to prospective clients.
  • Maintaining awareness of industry development and may author related publications.
  • Serving as Regional/Multiregional/Global Therapeutic Lead for specific indication(s).

Skills and Requirements:

  • A Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education, along with Board Certification, or equivalent, from the country or region of residence and work.
  • A minimum of 5 years' experience in clinical medicine, in addition to 4 years' clinical trials experience as an investigator or in the Pharma, CRO, or Biotech industry.
  • Robust and current knowledge of scientific, clinical, regulatory, commercial and competitive landscape in applicable therapeutic area.
  • Knowledge of applicable federal and local regulations and guidelines pertaining to clinical research.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

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 contact Tom Russell at +44 203 824 6104 or upload your CV 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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