Medical Director, Pulmonology - Paris

Job Description:
Our client is a global CRO who are seeking a Medical Director in their Paris office.

This role is an essential function within the Global Medical Department responsible for medical monitoring of assigned projects and providing expertise on all medical related aspects within the field of Pulmonology.

Main Accountabilities:

- Medical monitoring - answering day to day medical and scientific questions, provide daily medical support to staff or site (investigator/study coordinator).
- Review and sign off adverse events reports for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness; provide reports to European Regulatory Authorities, FDA or other regulatory agencies; provide sponsors with periodic experience reports summarizing adverse events as required by the sponsor or authorities.
- Provide support in preparation of Periodic Safety Update Reports (PSURs).
- Provide medical input into Pharmacovigilance workflows and projects as required.
- Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication), establish the presence or absence of clinically meaningful trends and, if noted, follow up as appropriate with the project team, sponsor, investigator, and Regulatory Authorities.
- Review and sign off technical documents written by company with respect to medically relevant matters with particular attention to those relating to drug safety.
- Review coding of adverse events and concomitant medications for accuracy and consistency.
- Provide support for the preparation of clinical protocols, integrated clinical and statistical summary reports, journal articles, and other documents for clients/sponsors in conjunction with clients/sponsors or in conjunction with other PAREXEL departments.
- Attend and present material (such as therapeutic area training) as requested, at internal and external meetings (e.g. investigator meetings).
- Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
- Participate in Proposal Development Teams (PDTs) for client bid meetings.
- Maintain up-to-date knowledge of therapeutic area expertise by attending Professional Society Meetings.
- Provide support for marketing activities as requested.
- Provide medical expertise to client as contracted.
- Provide medical expertise and training to other personnel, as required.
- Be able to provide a 24 hours/day, 7 days/week availability per request.

Candidate Requirements:
Experience:

- Medically qualified in an acknowledged Medical School with either completion of Board certification in pulmonology or extensive clinical experience in pulmonology.
- Significant experience in Pharmaceutical Industry, including Research and Development of pulmonology products.
- Experience in clinical medicine (PULMONOLOGY) which is expected to be kept up-to-date.
- Maintain a current medical license.
- Knowledge of the drug development process.
- Excellent presentation skills.
- Excellent interpersonal skills.
- Excellent verbal / written communication skills.
- Excellent time management skills.
- Client focused approach to work.

"Due to the high volume of applications we currently receive, we are unable to respond to all candidates. If you do not hear from a Consultant within 5 working days unfortunately you have been unsuccessful on this occasion."