Senior Medical Director, FOTE/BOTE
At Santen, we're innovating therapies to improve the quality of life for patients worldwide. Our single focus in ophthalmology enables us to challenge unmet needs in the field-through passionate research, successful collaboration, and clarity of commitment. With over 130 years of investigative insight, Santen remains committed to the discovery, exploration, and development of ophthalmic therapies. As a global company, Santen is expanding to accommodate new and evolving initiatives in ophthalmic research, regulatory management, production, marketing, or distribution. Our clinical development network spans three continents, with centers in Europe, Japan, and the United States.
We are in search of top talent to help us meet our aggressive and important goals.
ABOUT THE POSITION:
The Senior Medical Director, FOTE/BOTE oversees and contributes a coordinated approach to expanding Santen's medical leadership in Ophthalmology for designated products and/or therapeutic areas and delivers appropriate medical insights to cross-functional stakeholders. Depending on the product lifecycle stage, The Senior Medical Director may: participate in review or concept development for clinical research, lead external advisory boards, deliver scientifically rigorous review of pre- and post-marketing disease state and product related materials, serve as a critical scientific interface across the Santen organization, and lead or contribute to other activities of strategic and scientific importance.
This role has global scope that requires skilled collaboration and cultural awareness as well as high technical acumen. The Senior Medical Director will interface with various levels of internal stakeholders in a highly matrixed environment.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
- By his/her scientific expertise and deep understanding of Santen and competitor data, serve as the scientific subject matter expert for multiple departments.
- Lead development and maintenance of scientific strategies for Innovative Products in Santen's back of the eye and front of the eye portfolio.
- Conduct data analyses, identifying data gaps in Santen data and in the literature and formulate plans to fill data gaps.
- Manage Santen's cross functional IST review committee, oversee IST contracts and study progress, ensuring budgets and timelines are met.
- Conduct cross functional Data Summits to further Santen's understanding of our clinical data and data in the literature.
- Manage repositories of available Santen data, making data and study related information accessible to the Global Medical Affairs team as needed.
- Formulate appropriate study design for Phase IIIB, Phase IV and PIP studies.
- Understand the level of scientific expertise across multiple department and proactively provide audience-appropriate internal scientific education.
- Facilitate advisory boards, identifying needs for external input, selecting appropriate advisors, and ensuring external input reaches all appropriate Santen stakeholders.
- Provide scientific input to Phase II and Phase III study designs as requested.
- Support dossier development with scientific, editorial or other support as requested.
- Participate on regulatory filing teams as requested.
- Serve as scientific subject matter expert on external podium presentations as requested.
- Establish and maintain strong peer-to-peer relationships with key medical thought leaders in the fields of retina and cornea.
- Liaise closely with Biomedical Sciences and Biostatistics departments to ensure Global Medical Affairs has access to current and accurate science.
- Provide rigorous scientific review of medical and promotional materials.
- Generate audience-appropriate scientific and medical insights to cross-functional teams at various levels within Santen organization.
- MD or PhD required
- Minimum 12 years previous relevant industry experience
- Ability to work from Emeryville, CA
- Previous experience as part of a Medical Affairs team; preferably with global experience
- Familiarity with the ophthalmic community
- Experience working on a number of clinical studies (or fewer if some are large multicenter studies), which have yielded clear-cut results
- Demonstrated ability to serve as scientific subject matter expert, including proactive data analysis and formulation of strategies to fill data gaps
- Expertise in satisfactory interpersonal relationships with others in the working environment, and in collaboration with physicians
- Strong presentation skills, and exemplary interpersonal communication skills, both oral and written
- History of communicating effectively to a variety of audiences
- Presented scientific data in conferences and supported the preparation of such presentations by investigators and Medical Thought Leaders
- Knowledge, understanding and adherence to global regulatory guidelines (e.g. FDA, EFIPA, PDMA, JPMA, PhRMA, etc.).
- Strong analytical, conceptual, administrative, and computer skills
- Ability to approach work with a strong domestic and global perspective
- Availability to travel 20-35%
For more information about our company and the work experience, please visit www.santenusa.com