Clinical Development Director - Neurologist required
One of the largest CROS in the global market is currently recruiting a Clinical Development Director - Neurologist 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.
The Clinical Development Director will provide medical, clinical, and scientific advisory expertise to all Quintiles divisions as requested, participating in all aspects of medical science involvement on assigned trials. They will serve as a medical expert during project delivery lifecycle and provide therapeutic and medical expertise to business development activities.
- 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 review and clarification of trial-related Adverse Events (AEs).
- Performing medical case reviews of Serious Adverse Events (SAEs), including review of 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 sites and principal investigator profiles, anticipated patient recruitment, and standard of care and competitive landscape.
- Attending and presenting at bid defence meetings, as required.
- Participating in strategic business development activities, including presentations to prospective clients.
- Maintaining an awareness of industry development and authoring 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.
- A 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.
- 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.
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 Terance Au at +44 203 861 8605 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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