Chief Medical Officer
Los Altos, CA

JOB SPECIFICATION

The Company

The Company is a clinical-stage, privately held BioPharma company focused on developing and commercializing breakthrough therapeutics for neuroendocrine, metabolic, and immune disorders. Diseases such as diabetes and metabolic syndrome are increasingly in need of novel treatments that provide patients with better treatment alternatives and help to curb soaring healthcare costs. The company is in the process of in-licensing early- and late-stage compounds that have the potential to unlock the complex hormonal relationship between metabolism, insulin resistance, and obesity.

With the rapidly growing global metabolic disease epidemic, which includes diabetes and obesity, there is a significant need to bring safer, more effective medications to physicians and patients world-wide. The Company’s business strategy, under the guidance of The Company’s experienced Management Team and world-class Scientific Advisory Board and Board of Directors, is to build a robust portfolio of high-potential products through in-licensing clinical-stage therapeutic candidates to meet the growing patient needs. The team uses its capabilities to rapidly and effectively shepherd these therapeutic candidates through critical development stages to de-risk them and maximize their commercial potential.  

The Position

The Chief Medical Officer will be a member of the executive team and will participate in overall strategic direction of the Company. This candidate will have overall responsibility for all aspects of the clinical department and report to the President & CEO.

Professional Responsibilities

Areas of specific responsibility and attention will include the following:

• Assist the CEO in developing and refining the development strategies for our portfolio of products.
• Provide leadership and management oversight for all clinical research and development operations. Develop and implement effective operating plans.
• Assures that all protocols, clinical trial databases, and SOPs are fully compliant with FDA or any other governing regulatory agency.
• Provides hands-on leadership and guidance to multidisciplinary project teams in the development and implementation of all clinical trial programs.
• Oversees the review of the safety data from clinical programs and is responsible for the integrated safety summary.
• Design, hire and train a staff appropriate to advance our portfolio.
• Identify, evaluate and develop new scientific collaborations and alliances necessary to support our strategic and operating plans.
• Levereage the Scientific Advisory and Strategic Development Boards as key, integrated resources.
• Develop and establish relationships with Key Opinion Leaders in our therapeutic areas of interest.
• Effectively and credibly communicate Clinical Program data, design, plans and strategy in terms that are understandable to investors, analysts, potential development partners, and other diverse external audiences.
• Support corporate development in the identification and review of new product candidates available for in-license or acquisition.

Candidate Qualifications

Candidates will have a background from the biotechnology/pharmaceutical industry with experience and success in the development of FDA approved therapeutic products, and be a strategic thinker.

Additionally, the ideal candidate will possess:

• Endocrinology training strongly preferred.
• 10 years of industry drug development, global Phase 3 diabetes drug development strongly preferred.
• Proven track record in successful clinical trial design.
• Strong FDA interaction.
• Direct experience with Pharmaceutical Company drug development, in license, and portfolio decision making.
• High energy, enthusiasm and excellent leadership and management skills.
• Strong communication and presentation skills, and an established network among clinical leaders, particularly in the endocrine and metabolism community
• Demonstrated ability to communicate clinical program goals and results to diverse audiences such as investors, analysts, and development partners.
• Strong leadership and experience in managing diverse personalities and functions to achieve successful integration of the team with positive results.
• Thorough knowledge of FDA requirements, gained through direct experience with the NDA approval process.