Volver a los resultados de búsqueda Clinical R&D Project Manager
Morgan Philips Executive Search
Farmacéutica y Asistencia sanitaria
General Responsibility The Clinical R&D Project Manager will work in the management of the Clinical R&D department to meet assigned clinical development objectives and provide scientific support to the management and other departments with respect to clinical issues.
Contribute to the overall clinical studies and strategic development plans for Chemo's finished dosage form projects. The main focus is on pharmacokinetic and bioequivalence studies (Phase I studies). For some specific projects, Phase III will also be conducted.
To provide scientific and medical support to other departments and to collaborate with other departments to facilitate the fulfilment of Company’s objectives: Pharmacovigilance, Regulatory Affairs, Intellectual Property, Commercial, or other.
To continuously maintain a quality system to ensure full compliance with GCP.
Act as a medical resource for the company as a whole and in particular for the clinical operations department.
Provide medical expertise in adverse experience review, together with the VP department when necessary, and discuss patient management issues with investigators. Review laboratory alerts, laboratory reports and subject profiles as defined in the medical safety monitoring plan.
Coordinate and oversee interim analyses and final analyses/final trial reports, as well as preparation for manuscript development and submission.
Advise company-wide on medical, regulatory and clinical issues and activities related to the assigned product portfolio.
Develop and maintain up-to-date knowledge of therapeutic areas through literature review, discussions with key opinion leaders and key stakeholders, participation in cross-functional interactions, attendance at scientific congresses, etc.
Prepare medical and scientific evidence together with a strong business case to communicate the benefits of the product portfolio to the market and effectively manage advisory boards.
Requirements and Personal Skills
Degree in Medicine or Pharmacy. Further specialization in Clinical Pharmacology or similar highly desirable.
Fluent in English. Fluent in Spanish highly recommended. Knowledge of other languages will be an asset.
>2 years of experience in a similar Clinical R&D position or medical department.
Deep knowledge in Generics, Pharmacokinetic and Bioequivalence Studies, Biopharmacy, and/or Regulatory Affairs will be very valuable.
Willingness to travel (20%).
+34 91 78 839 88
Morgan Philips Executive Search
Paseo de la Castellana 141, 17º
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