VP, Global Medical Affairs

Location
Emeryville, CA, United States
Posted
Apr 18, 2019
Ref
o3hU7fw5
Hotbed
Biotech Bay
Required Education
Doctorate/PHD/MD
Position Type
Full time
COMPANY DESCRIPTION

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.

PRIMARY PURPOSE OF POSITION:

The Vice President position is responsible for leadership of the Global Medical Affairs function within Global R&D.

MAJOR DUTIES OF POSITION:The Vice President of Medical Affairs serves as a source of advice for management and colleagues in Development, Research and Marketing organizations, by virtue of his/her extensive drug development experience and product knowledge. The Vice President of Medical Affairs and team will work closely with not only Global Clinical Development but also Global Marketing, Global Market Access, Global Market Research, regional Marketing and Sales Groups, and oversees the following:
  • Medical communication
  • Medical Science Liaison management
  • Publications planning
  • Medical content development and promotional review - compliance
  • Regulatory, and safe harbor guidelines
  • Relevant portions of Sales Force Training
  • Medical education
  • Investigator Initiated Clinical Trials / related clinical development
  • Phase IV Trials
  • Drug Registries
  • Formulary Support
  • Reimbursement, Pharmacoeconomic support, and implementation
  • Continuing Medical Education (CME)
  • Proposes new directions for Clinical Research / Development(e.g., new product claims or research methods)
  • Manages and develops a best in class Global Medical Affairs Organization
  • Collaborates with the Marketing team on product positioning and market access strategy
  • Manages and cultivates key opinion leaders globally
  • Serves on expert committees outside Santen, on editorial boards, planning committees, major scientific meetings / societies worldwide
  • Interacts with regulatory agencies worldwide (FDA, PMDA, EMA)
  • Perform other duties as necessary as assigned by management
KNOWLEDGE AND SKILL REQUIREMENTS:
  • Required: MD, MD/PhD, or MD/MBA graduate of an accredited medical school with appropriate Clinical and Research training, or the equivalent
  • Board certification / Eligibility or equivalent in Ophthalmology preferred
  • Recognized Medical Affairs or Clinical Research & Development expert with a minimum of fiftneen (15) years in BioPharmaceutical industry Basic research experience plus
  • Creativity and innovativeness are clearly expected. Should have completed a number of clinical studies (or fewer if some are large multicenter studies), which have yielded clear-cut results and demonstrated the ability to establish satisfactory interpersonal relationships with others in the working environment, and to manage other physicians
  • Experience developing and implementing novel endpoints for clinical programs
  • Authored papers in leading journals, on which he/she is the actual first author or major contributor (i.e., drafted manuscript, responded to reviewers' criticisms etc.)
  • Respect for diversity and the ability to work effectively with multiple cultures globally; previous global work experience preferred
  • Experience managing outsourcing to CROs is desirable
  • Previous experience working in a matrixed organization structure desirable
  • Demonstrated track record of producing tangible results with measurable outcomes
  • Proven track record of outstanding leadership characteristics exemplified through clarity of goal setting, the ability to inspire others, to set a positive example by providing assistance, recognition and encouragement