Company: inVentiv Health Clinical
Reference: AS MD BER / 5342
Closing Date: 14 Dec 16
Salary (£): Negotiable
Director Medical Affairs m/f Office based in Berlin, Germany Full-time (1 FTE)inVentiv Health Clinical is a leading provider of global drug development services to pharmaceutical, biotechnology, generic drug, and medical device companies. With 15.000 passionate employees supporting clients in more than 90 countries, inVentiv Health Clinical works to accelerate high quality drug development programs of all sizes around the world.
inVentiv Health Clinical are currently recruiting for dedicated and motivated Director Medical Affairs (Medical Director) to work office based in Berlin. You will be working for a global Pharmaceutical client, playing an integral role within an established team.
This is a great opportunity for someone looking to develop their experience in biopharmaceuticals and work on pivotal studies within an innovative organisation.
To apply for this position you must have previously worked as a Direcor of Medical Affairs (Medical Director), hold an EU passport or valid German work visa, speak fluent English and be willing to work office-based in Berlin/Germany.
1 Act as operational Medical Director
1 Manage the sponsor's congress plan and publication strategy
1 Manage and liaise with investigators, key opinion leaders, and study groups in Europe & US
1 Interpretation of clinical trial data and reviews by DSMC
1 Medical science expert for reviewing relevant data for the Clinical Development Department
1 Presentation and moderation during medical-scientific communication activities (external and internal)
1 Medical monitor (sponsor part only) for ongoing clinical trials
1 Contribute during partnering activities
1 Act as operational Medical Director for the clinical development programs in colon cancer, lung cancer, melanoma and other indications
1 Manage the sponsor's congress plan and publication strategy, to build awareness of ongoing clinical trials and data
1 Manage and liaise with investigators, key opinion leaders, and study groups in Europe & US to evaluate ongoing clinical trials, assess new clinical programs and manage patient recruitment expectations
1 Be responsible for interpretation of clinical trial data and reviews by DSMC meetings (as required)
1 Act as medical science expert for reviewing clinical study protocol, Investigator Brochure, DSUR, SUSAR and clinical study reports, supported by the medical manager
1 Present key clinical findings to internal and external constituents
1 Review of coding of medical data, SAEs, review safety reports (esp. CIOMS), patient profile listings, protocol deviations, form a liaison with external medical monitors and other duties (as needed) throughout the clinical studies, supported by the medical manager
1 Contribute in an active and ongoing manner to the scientific, clinical and commercial development of company’s product candidates (e.g., target product profile)
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