The Global MedicalLead develops and implements the Global Medical Strategy and contributes to the Global vision and medical activities of the complete portfolio with, at the same time, a particular heed to local contexts, issues and solutions.
Activities :
Ensure the medical input in the overall strategy (drug development, drug’s licensing, filing, market access, communication) and a pro-active understanding of medical need within the therapeutic area.
Ensure the development of GMPA Plans for product(s) / indication(s) / Therapeutic Area and other strategic documents:
Strategic documents including internal training, safety requests, medical information
Q&As, clinical study reports, regulatory submissions, annual product strategy and communication plans, factsheets, and press releases
Develop awareness and understanding of the portfolio and contribute to the life cycle management of medicines for GMPA team
Develop, implement and monitor the Global Medical Plans (i.e Orientation & Action plan) in collaboration with Data Generation and Medical Communication
Co-create and oversee the Global publication and congress strategy
Ensure excellent collaboration internally with the other GMPA departments (International Medical Affairs, Medical Evaluation, Publication, Medical Information, Patient In), Franchises, Operations, Medical Affairs within subsidiaries, R&D, BD&L, worldwide training.
Establish and entertain good external contacts with TAEs in close collaboration with the Global Medical Communication team (co-create TAEs engagement plan, scientific exchanges, Advisory Board, …)
Ensure Medical Affairs team works closely with marketing to translate data into messages.
Contribute to the medical value of cross functional projects with the Franchise.
Design the medical narrative that supports the product(s) and MSL Material
Bring medical input in the existing and future portfolio from early clinical development
Contribute to the development of phase 3b/4 program, including Expanded Access Programs
Develop and revise in/out of scope of Investigator Initiated Trials
Responsible for scientific evaluation and alignment with indication/ product strategy for new concepts/ potential IIT programs
Interact with the key countries directly and bring their perspectives to the global projects
Support regional/local medical teams and activities when needed
Create cross-country product teams with global and local Medical Affairs, when applicable
Apply the group ethical and compliance standards to all communication with experts and key stakeholders (TAEs, scientific bodies, HCPs, patients and patients’ associations, caregivers... partners and vendors)
Contribute to building relationships with TAEs, scientific bodies, HCPs, patients and patient’s associations and caregivers
Review and approve medical and scientific content of Regulatory, Medical Affairs, training and Franchise (marketing and market access)
Be aware of and apply legal, regulatory, compliance and company standards to all actions
Be responsible for competitive intelligence
Ensure GMPA budget definition and monitoring;
Educational background :
MD, Pharm D or PhD
Other :
Position in France or in Europ.
Availability for and willingness to travel worldwide
Previous experience in Oncology
Description du profil :
Educational background :
MD, Pharm D or PhD
Other :
Position in France or in Europ.
Availability for and willingness to travel worldwide
Niveau hiérarchique
Directeur
Type d’emploi
Temps plein
Fonction
Sciences
Secteurs
Fabrication de produits pharmaceutiques
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