WorldWide Medical Affairs Director Hepatology
In this role you are responsible for providing medical and scientific leadership to medical brand teams and other brand related functions from pre-
launch through Life Cycle Management. You will support the Global Brand Medical Director (GBMD) in the execution of Medical Affairs (MA) activities in alignment with Global Medical Affairs (GMA) functions.
Your main accountabilities will be :
1. Build together with the GBMD the Medical Affairs strategy.
a. Provide support on the Medical Affairs Plan and other line functions plans (CDP, IPS, etc.).
b. Provide input on scientific content of Program / brand(s) publication plan to assigned Medical Communication Leaders (MCLs).
c. Support / lead data mining and Real World Evidence (RWE) activities and support / lead process.
d. Provide medical support / input to GBMD for internal and external medical education and communication initiatives (e.
g., speaker training, advocacy, Medical Experts strategy, advisory boards, Medical Science Liaison (MSL) support and education, launch support, congress planning and execution).
e. The WorldWide Medical Affairs Director is the MSL point of contact with the Global Medical Affairs Team (GMAT) and is responsible for providing compound and / or disease area-
related scientific training and materials to MSLs. The WorldWide Medical Affairs Director is responsible to channel the GMAT deliverables to MSLs in alignment with Regional Medical Directors / Regional Franchise Heads.
The WorldWide Medical Affairs Director brings to the GMAT the medical insights gathered by the MSLs based on feedback from external stakeholders.
f. Provide the medical input to MSL materials and related activities and supports the development of these deliverables in cooperation with the MCL
2. Provide medical scientific input for the assigned program / brand(s) to :
a. Develop integrated Product Strategy (IPS), MA strategy and related MA plan
b. Develop Clinical Development Plan (CDP section related to MA activities)
c. Guide and develop local MA clinical programs and provide support in execution
d. Value dossiers and participation at payer advisory boards
e. Provide medical inputs to prepare Global guidance documents.
f. Provide medical / scientific support for Medical Science Liaisons (MSLs)
g. Provide medical input in Periodic Safety Update Reporting (PSURs) and Development Safety Update Reporting (DSURs).
3. Serve as a disease area scientific and medical expert for internal customers / stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory development, device development, Marketing, Novartis Country Pharma Organizations (CPOs), and other line functions within GMA and external customers e.
g., Health Care Professionals (HCPs), Market Access and Patient Advocacy Groups (PAGs).
4. For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, non-interventional studies without regulatory impact) within program / brand, as a member of the Global Medical Affairs Team (GMAT), you will provide medical scientific input to, e.g. :
a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensure timely and on budget delivery.
b. Develop or contribute to study-related documents (e.g. concept sheets, protocols, case report forms, statistical plan, data analysis plan, study reports, publications).
c. Develop / contribute and review presentation materials for study / program-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and external speaker at meetings when required.
d. Ongoing review of clinical study data, final analysis and interpretation, in collaboration with the Brand Safety Leader, appropriate Global Clinical Team (GCT) members and the GBT (Global Brand Team).
e. Act as medical key contact point for assigned MA studies.
5. Support WWBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.
6. Deputize for the WWBMD in Global Clinical Team (GCT), Global Project Team (GPT), Global Brand Team (GBT), Clinical Development Unit (CDU), CPO WebEx Alignment meetings and internal decision boards as the Medical Affairs advocate.
7. Represent Novartis at key medical conferences.
MD or PhD with 6 years of clinical research experience, preferably in the Health Industry
OR MD, PharmD or PhD with knowledge and experience in medical affairs activities, with 6 years experience
Fluent English (oral and written)
Skills & Experience :