Chief Medical Officer
Chief Medical Officer
POSITION SUMMARY
The Chief Medical Officer is a strategic partner to the Chief Executive Officer, helps build, develop, lead and drive the Companys preclinical through clinical pipeline. This leader is responsible for the companys drug development portfolio including responsibility for prioritizing and accelerating the development of Companys drug candidates.The CMO serves as the key member of the Executive Team and actively participates in strategic planning, partnering discussions and presentations to the Board of Directors and investors.
Key Responsibilities
Areas of specific responsibility and attention will include the following:
Provide leadership and clinical perspective to the research, development, quality and comprehensive regulatory strategies.
Manage the overall clinical development for lead programs including early development, clinical proof of concept, pivotal studies and regulatory submissions.
Ensure Company meets its clinical and regulatory milestones.
Represent Company at the highest level at the FDA, EMEA and other regulatory agencies.
Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings and tracking literature.
Represent and manage the companys clinical and regulatory programs to diverse audiences including: FDA, shareholders, corporate partners, Board of Directors and other key stakeholders.
Represent Company both internally and externally vis--vis the scientific and business communities including scientific conferences, presentations, industry and Wall Street.
Build and maintain solid working relationships with key opinion leaders and lead clinical investigators. Establish and foster relationships with the international scientific and medical community.
Actively assist in seeking product and/or technology alliances with appropriate pharmaceutical company partners to enhance/expedite the development of the companys assets.
Helping to establish and maintain collaborations with partners in academia, government and industry.
PROFESSIONAL Experience/QUALIFICATIONS
The successful candidate must have extensive senior-level experience in clinical development, ideally with both larger pharmaceutical as well as with biotechnology companies. This person will have a thorough understanding of all the requirements and processes needed to take a potential drug through clinical development and ultimately registration.
Key requirements will include:
An MD or MD/PhD with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of therapeutic programs, specifically in the Nephrology space is essential.
Strong leadership skills and proven biopharmaceutical industry experience in leading clinical development from preclinical to phase 3 therapeutic programs. A record of accomplishment including developing, planning, designing and implementing clinical studies in the Nephrology