Associate Medical Director, GCPO
At Santen, we are 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:
As part of our Global Clinical Physicians and Operations (GCPO) group, the Associate Medical Director is accountable to develop and execute a forward-thinking strategy by supporting the cross functional core team as the medical expert in late stage development. The individual is expected to be highly experienced in drug development, and possess extraordinary leadership competencies and the perspective insights to develop strategy around new medicines. The position also includes extensive involvement with global, regional and local Research & Development colleagues, Marketing and Sales, Regulatory and Health Authorities, Healthcare providers and Key Opinion Leaders.
ESSENTIAL DUTIES AND KEY DELIVERABLES:
- Provide strategic input for the R&D pipeline to support existing and future products
- Ensures medical excellence in execution and oversight of development-stage studies
- Partners with business development to develop and pursue sound opportunities for new products through a focus on in-licensing of new compounds and technologies in late stage development
- Facilitate and merge strong science into commercially viable products utilizing aggressive timelines; integrate scientific rigor, medical need and commercial value into compelling clinical plans culminating in successful registration and launch
- Builds strong relationships and ties with outside stakeholders, including key opinion leaders and patient communities, as needed
- Support the development of reliable and high-value publication strategies for new and existing products
- Ensured regulatory compliance and adherence to GCP standards
- Leads global & regional clinical and scientific advisory boards and liaises with global & regional key opinion leaders on generating ideas for future product/device development, expanded labeling of existing products/devices and scientific communication of safety/efficacy of current products
- Pilots new projects involving the medical community in alliance with global functions
- Supports regional Marketing by working closely with country scientific affairs managers on development of medical communication, advises primary marketing personnel regarding features, benefits and competitive advantages
- Participates in local, state, national and international medical/industry governmental meetings, providing strategic guidance to the Division through participation in these key associations to influence policy and regulations regarding medical devices
- Builds strong relationships and ties with outside stakeholders, including with key opinion leaders and patient communities, as needed
Core competencies, education, and experience.
- MD required. MD/MBA or MD/PhD preferred
- Position will be filled at level commensurate with experience, with a minimum of 2-7+ years of pharmaceutical industry experience in clinical development functions across Phase I through IV required
- Ophthalmology experience is strongly preferred
- Experience in the successful development of rare disease therapeutics is preferred, but not required. Regenerative Medicine (Gene & Cell therapy) knowledge/familiarity would also be additive. More important than specific therapeutic expertise is the ability to be creative and strategic around developing processes that may be without precedent
- Sound scientific and clinical judgment
- A strong business sense; able to link the scientific and business needs
- Ability to travel
- Excellent communication skills, self-motivated, innovative, with highest level of professional ethics, accountability and integrity
- Experience leading and collaborating cross-functionally with R&D and non-R&D key partner groups, thereby helping to shape the future of the entire Santen organization
- Experience with clinical study design, health economics or medical statistics
- Team oriented with the confidence, maturity and integrity to work effectively with Santen senior leaders, key opinion leaders and health care professionals
- Able to demonstrate a high level of strategic thinking and business acumen within a strong and well educated group in order to effectively manage internal and external relationships and gain credibility in the role
For more information about our company and the work experience, please visit www.santenusa.com.