US-NJ, Medical Director, Early Development 222900BR-MZ
Medical Director, Early Development
US GEN MED
East Hanover, NJ
Research & Development
Novartis is currently recruiting for a Medical Director - Early Development to provide medical affairs, clinical drug development and strategic, cross-functional leadership to effectively shape, influence, develop and drive strategies and medical plans that ensure maximal regulatory, reimbursement and commercial success of early development compounds (proof of concept Phase 3b) in the US. This position will be located in East Hanover, NJ and will be filled at a level commensurate with experience.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. It is a pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of this 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.
The Medical Director - Early Development will partner proactively and effectively with leaders across commercial, US Medical Affairs, global (Clinical development, Global Medical Affairs, and Global Clinical and Brand Teams) and Novartis Institute for Biomedical Research (NIBR), leveraging strong technical/medical expertise, business/market acumen and a comprehensive understanding of business strategy, to develop strategies and medical plans that ensure maximal regulatory, reimbursement and commercial success of compounds in the US.
Additional responsibilities include the following:
Provide strategic US Medical input to Global Development on clinical development programs (Phase POC-Phase 3b)
Partner with global and US clinical, medical and commercial teams to ensure that registration programs are rigorous and that outputs meet specific US needs
Ensure program strategy, value story and value proposition are evidence-based and consistent with US treatment practices
Lead the generation of early development strategies and tactical plans that support US commercial, reimbursement and regulatory success
Provide scientifically and clinically sound guidance for BD&L evaluations
Identify gaps in registration programs and lead the design and execution of Phase 3b studies to address US-specific gaps
Develop and enhance relationships with diverse external stakeholders through congress participation and leadership of scientific/medical exchanges
Rapidly develop/enhance credibility with NIBR with a focus on enhancing LPT understanding of pipeline
Manage work across a matrix organization and influence without authority
Ensure customer perspective is fully integrated into all LPT deliverables
Brief all levels of management on key topics and leverage their support for LPT success
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.
Position will be filled at a level commensurate with experience.
MD, DO, or PhD required.
Minimum of 5 years of pharmaceutical industry experience required in the areas of Medical Affairs and/or Clinical Development
Experience with the Ophthalmology therapeutic area is a plus
Proven ability to build and lead highly productive cross-functional relationships and teams internally and externally within a matrixed and resource-constrained environment
Proven ability to translate science/clinical/medical information to non-medical colleagues and customers
Project management expertise with recent experience leading large projects/organizations
Strong organizational skills and ability to prioritize across competing agendas while managing stakeholders needs
Proven track record of being an effective, open, available and transparent communicator
Excellent oral and written communication skills
Ability to travel (U.S. and Europe; 15-25% annually).
Documented experience in designing and leading operational execution of clinical trials
Firm working knowledge of GCP, scientific and clinical method-ology, protocol design, project management and regulatory requirements for clinical studies designated for review by regulatory authorities
U.S. marketing experience, to include a well-documented history of bridging proactive relationships among product development, preclinical science, clinical development and market access, and brand teams
A well-established network within the medical research community
Advanced understanding of US reimbursement landscape
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