Job description
Novartis Basel are seeking a Global Medical Affairs Director (GMAD) to be responsible for providing medical and scientific leadership into medical brand teams and other brand related functions from pre-launch through the whole life cycle. The GMAD supports the Global Brand Medical Director in the execution of Medical Affairs activities in alignment with GMA&HEOR functions.
Major Accountabilities
1. For the assigned Medical Affairs studies (Phase IIIB-IV, PMS, observational studies without regulatory impact) within program/brand, as a member of the Global Medical Affairs Team (GMAT), provides medical scientific input to, e.g.:
a. Key activities related to planning, execution and reporting of Global Medical Affairs studies and ensures timely and on budget delivery.
b. Development of study related documents (e.g. concept sheets, protocols, case report forms, data analysis plan, study reports, publications).
c. Development of presentation material for study related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and speaker at meetings.
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.
2. 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 local medical organizations, and other line functions within GMA&HEOR and external customers e.g., Key Opinion Leaders (KOLs) and patient advocacy groups.
3. Build together with the GBMD/Portfolio GBMD a highly influential medical and scientifically based platform:
a. Program/brand(s) publication plan and ensure execution in collaboration with assigned Medical Communication Leaders (MCLs), e.g. provide input on scientific content, support/lead data mining activities and support review processes associated with execution.
b. Support/ lead internal and external medical education and communication initiatives (e.g., speaker training, advocacy, KOL strategy, advisory boards, launch support, congress planning and execution).
4. Provide medical scientific input for the assigned program/brand(s) to:
a. Development of Integrated Product Strategy (IPS), MA strategy and related MA plan
b. Development of Clinical Development Plan (CDP section related to MA activities)
c. Guidance and development of local MA clinical programs and provide support in execution
d. Value dossiers and participation at payer advisory boards
e. Lead MAST (Medical Affairs Study Team) to provide guidance to CPOs related to their MA study program; review, approve and follow up on local MA studies
5. Support GBMD/portfolio GBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.
6. Support or deputize GBMD/Portfolio GBMD in providing input into brand safety related activities for the assigned program. 7. Deputize for the GBMD/Portfolio GBMD in Global Clinical Team (GCT), Global Brand Team (GBT), Clinical Scientific Unit (CSU) and internal decision boards as the Medical Affairs spokesperson.
8. Contribute to talent and career development of MA and Development colleagues like MCLs, SciOps, CTH, CM through active participation in on-boarding, training and mentoring activities.
Ideal Background:
• MD or PhD with unique knowledge for successful clinical program development and execution, with ≥ 6 years of clinical research experience required.
Or
• MD with specialty with board certification or equivalent, with ≥ 3 years of clinical research experience required.
Desired Skills and Experience
• Fluent English (oral and written)
• Medical Affairs experience
• Extensive Clinical Studies experience
• Proven ability to interpret, discuss and represent efficacy and safety data relating to the assigned area.
• Proven ability to work both independently or in a cross functional team setting, including a matrix environment.
• Demonstrated ability to establish strong scientific partnership with key investigators in RA.
• Medical and/or scientific expertise within the field of RA.
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Email: jobs@aarenconsultants.in
