| || 215862BR |
| || Therapeutic Area Head Cardio Metabolics |
| || PHARMA |
| || Region Europe GenMed |
| || Belgium |
| || Vilvoorde |
| || NOV PHA BEL |
| || Research & Development |
| || Cardiovascular and Metabolism |
| || Full Time |
| || Regular |
| || Manage associates in the Specialty Medicine locally to drive Novartis message delivery to key influencers and stakeholders. Responsible for medical success of global TA/BU development projects at the CPO (Country Pharma Organisation) level. Drive Medical Affairs in the local business franchise and ensure alignment between global project strategy & local CPO needs.
1. Expertise and Medical Support: Provides broad and deep understanding of the therapeutic area cross-functionally. Seen as credible medical and scientific expert by internal and external customers.
2. Drives collaboration of TA/BU associates with CPO, Regional and Global Teams in local Clinical Development activities for the TA/BU.
3. Oversees all local medical and scientific contributions to global clinical development programs.
4. Provides strategic and tactical guidance for clinical teams and allied departments in local CPO. Contributes senior level expertise for CPO projects as member of relevant local management boards (e.g. local BF/BU), as per assignment.
5. Local studies and publications: Actively ensures together with TA/BU associates quality of study protocols, reports, summaries and publications from Post Phase III activities.
6. Oversees together with CS&E local clinical trial adverse event reporting as well as clinical input and oversight into adherence to GCP together with ICRO.
7. Ensure the right mix of KOLs in investigators selected for local and global studies.
8. As member of the local BF/BU Board, collaborate actively with Marketing partners to ensure development and implementation of the strategic product plan.
9. Drives Medical Affairs together with TA/BU associates in the local BF/BU to deliver Novartis messages to key influencers and stakeholders, with ownership for exceeding customers' needs and expectations across the therapeutic area.
10. Supports interactions with Scientific Operations / Medical Scientific Liaisons to ensure market preparation pre- and post-launch.
11. Assists in ensuring local adherence to NP4 and local regulations.
12. Develops and supports together with TA/BU associates external contacts (KOLs, influencers, key external customers investigators, academic and regulatory community).
13. Coordinates and ensures product / disease and therapies training on assigned therapy area and medicines to internal and external customers, including the field force
14. Presents highest ethical standards and contributes proactively to a credible image for Novartis CPO in the local Health Care and Medical community.
15. Manage all TA/BU associates locally with commitment to develop people, process, innovation and external focus.
16. Responsible for resource planning and management (FTEs and phase IV budget) within TA/BU.
| || Medical Doctor. Fluency in English, Dutch and French.
1. More than 5 years of demonstrated managerial experience in the pharmaceutical industry with focus on medical research or equivalent experience obtained in hospital environment in the therapeutic area of neuroscience.
2. State-of-the-art medical, scientific and clinical knowledge. Expertise in MS strongly preferred or – at least – specialization and expertise in the relevant TA.
3. Strong leadership and proven management,planning, and communication skills.
4. Management of both scientific and operational aspects of clinical drug development.
5. Strong interpersonal, communication, negotiation,and presentation skills.
6. Professional respect and credibility with extensive knowledge of therapeutic area, encompassing business strategy and market trends.
7. Familiar with respective health authority, GCP and ICH requirements, including regulations of Promotional materials.
8. Expert in all aspects of clinical drug development including experience designing and/or executing clinical studies to address local BF/BU needs.
9. Successful development and implementation of innovative programs and processes.
10. Pronounced interest in commercial success of projects/products in TA/BU