Clinical Research Medical Director Ophthalmology - Remote Work Arrangement
38 Million! 38 million Americans over age 40 currently have low vision, an age-related eye disease, or are blindthis is expected to increase to 50 million by 2020. At Novartis, we strive to develop therapies that will halt - or even reverse the ocular damage and degeneration that eventually leads to blindness. Be part of a team that brings life changing medicine to patients affected by eye disease. The Clinical Research Medical Director will provide medical leadership and expertise to ophthalmology clinical trials executed in US.
Primary medical responsibility for Development Clinical Trials this includes protocol feasibility, physician to physician contact, protocol training, strategic input in recruitment plans, medical issue/question management, safety review and local regulatory interaction. Provide strategic medical input for a given therapeutic area into protocol design at a global level. Cooperates with US and Global Medical Affairs colleagues to identify/involve investigators and key opinion leaders in order to exploit the value of the assigned project(s) in the context of the investigational product(s). Discussion with key opinion leaders regarding compounds in early development.
Your responsibilities include, but not limited to:
US medical lead for global clinical trials. GCT US medical representative.
Lead and/or perform US medical feasibility. Provide feedback during protocol development and amendments to address US needs/obstacles or opportunities. Assess needs and opportunities to improve trial recruitment /retention to meet US needs and global timelines. Seek alignment with internal/external stakeholders
Provide Medical Expertise specific to US. Scientific concept discussions with internal and external stakeholders.
Development of protocol /disease state educational strategy for internal and external stakeholders. Subject safety consultant for sites on inclusion/exclusion, study drug, AE/SAE, etc. Develop investigator engagement activities at medical conferences and other meetings
Development and implementation of recruitment, retention and protocol compliance strategies. Develop strategies for early identification to patients including patient flow specific to disease, geographic location and type of clinical practice. Development of site specific recruitment and escalation plans. Asses need to escalate trial
Identify unmet US needs and future trial opportunities. Develop strategies for early identification of sites (including site feasibility) and determining site profile.
Develop early and ongoing clinician/site engagement strategies. Development of investigators and trial centers
Position will be filled at level commensurate with experience.
MD preferred. Also open to a PharmD, DO or DNP.
Subspecialty training in Ophthalmology highly desired.
Experience in a pharmaceutical / medical practice and fully trained in all aspects of drug development including clinical research, GCP, local regulatory requirements and data privacy laws.
Ability to lead a study from the medical perspective, and a demonstrated capability to problem-solve and mediate complex medical / operational issues within the regional and therapeutic area. A minimum of two years pharmaceutical industry or clinical trial management experience required.
Strong personal integrity, teamwork abilities and a customer focus are necessary.
Must be strong team player who can effectively work cross-functionally in a matrix.
Excellent interpersonal, communication, and presentation skills are required.
Must be able to organize, prioritize and work effectively in a constantly changing environment.
This is a field-based position, lives within assigned geographic region (preferred).
Able and willing to travel Extensive travel (60-70%) is required with this position.
Why consider Novartis?
750 million. That's how many lives our products touch. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.
We are Novartis. Join us and help us reimagine medicine.
This is a remote position.