US-NJ, Global Medical Affairs Director, Ophthalmology - Brolucizumab (RTH) 221125BR-MZ
Global Medical Affairs Director, Ophthalmology - Brolucizumab (RTH)
East Hanover, NJ
Research & Development
Novartis is recruiting for a Global Medical Affairs Director, Brolucizumab (RTH). 2 positions are available. These positions will be located in East Hanover, New Jersey (however, as these are global roles, some flexibility may exist).
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of which makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
This Global Medical Affairs (GMA) Director will be responsible for providing medical and scientific leadership into the multi-functional brand/indication team. The GMA Director supports the GBMD in the execution of MA activities in alignment with GMA functions in support of Brolucizumab (RTH).
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.:
oKey activities related to planning, executing and reporting Global Medical Affairs studies and ensure timely and on budget delivery. Strategic thinker able to conduct gap analysis and data generation strategies to support the brand from a commercial, medical and market access perspective.
oDevelop study-related documents (e.g. concept sheets, protocols, case report forms, data analysis plan, study reports, publications).
oDevelop presentation material and lead study-related advisory boards, investigator meetings, protocol training meetings for Novartis local medical organizations and speaker at meetings.
oOn-going review clinical study data, final analysis and interpretation.
oAct as medical key contact point for assigned MA studies.
Serve as a disease area scientific and medical expert for internal customers/stakeholders, e.g., GCT, Scientific Review Committee, research, exploratory 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).
Build together with the GBMD Medical Affairs strategy a highly influential medical and scientifically based platform:
oProvide support on the Medical Affairs Plan and other lines functions plans (CDP, IPS, etc.)
oProvide input on scientific content of Program/brand(s) publication plan to assigned Medical Communication Leaders (MCLs)
oSupport/lead data mining and Real World Evidence (RWE) activities and support/lead process.
oProvides medical support/ input to GBMD and to MCL or deputize in selected cases for internal and external medical education and communication initiatives (e.g., speaker training, advocacy, Medical Experts strategy, advisory boards, MSL support and education, launch support, congress planning and execution).
oGMA Director is responsible for providing compound and/or disease area-related scientific training and materials to MSLs. The GMA Director is responsible to channel the GMAT deliverables to MSLs in alignment with Regional Medical Directors/Regional Franchise Heads. The GMA Director brings to the GMAT the medical insights gathered by the MSLs based on feedback from external stakeholders.
oProvides the medical input to MSL materials and related activities and supports the development of these deliverables in cooperation with the MCL
Provide medical scientific input for the assigned program/brand(s) to:
oDevelop integrated Product Strategy (IPS), MA strategy and related MA plan
oDevelop/support Clinical Development Plan (CDP section related to MA activities)
oGuide and develop local MA clinical programs and provide support in execution
oValue dossiers and participation at payer advisory boards
oProvide medical inputs to prepare Global guidance documents.
oProvide medical/scientific support for Medical Science Liaisons (MSLs)
oProvides medical input in Periodic Safety Update Reporting (PSURs) and Development Safety Update Reporting (DSURs).
Support GBMD in ensuring compliance of promotional and non-promotional global material and all Medical Affairs activities.
Support or deputize GBMD in providing input into brand safety related activities for the assigned program; PSURs/DSURs.
Deputize for the GBMD 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.
Contribute to talent and career development of MA and Development colleagues like MCLs, Field Medical Experts, Clinical Trial staff, through active participation in on-boarding, training and mentoring activities.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
MD, PharmD, PhD or DO degree with a minimum of 3-5 years of pharmaceutical industry experience in medical affairs is required; Board Certification/Eligibility in Ophthalmology or similar experience in Field of Ophthalmology is preferred. Academic candidates with a strong background in clinical ophthalmology development and previous strategic collaboration with pharmaceutical industry may be considered.
Fluent English (Oral and Written).
Advanced medical/scientific writing and communication skills.
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 assigned TA.
Medical and/or scientific expertise within a disease area required.
Experience with ophthalmology is a strong plus.
Must have Country/Regional/Global Medical Affairs experience.
Real World Evidence experience/exposure is highly desired.
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