Chief Medical Officer
Our firm, Targazyme, Inc. (formerly America Stem Cell, Inc.), is a clinical-stage start-up biopharmaceutical company developing enzyme platform technologies/products to improve efficacy outcomes for cell therapy and cancer. The corporate office is located in Carlsbad, CA. Targazyme, Inc. is entrepreneurial and fast-moving in nature and desires additional team members with similar qualities.
The incoming Chief Medical Officer will report to the Chief Executive Officer and will be responsible for the full scope of clinical functions, including pre-clinical activities through Phase I-IV trial design and execution, clinical research (including human PK/PD) and data analysis and management. He or she will work closely with the development team, in house or outsourced, ensuring effective pre-clinical and clinical trial strategy, design and execution and regulatory submission. The Chief Medical Officer will provide leadership to the organization, moving compounds into, and through, the clinical development process. Additionally, he or she will participate in financing and business development activities providing a clinical perspective and scientific review for internal decision making and to external investors and analysts.
The Chief Medical Officer will:
• Lead the clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s)
• Develop a pre-clinical and clinical trial strategy and formulate development budgets
• Lead the development and execution of such strategy including writing of the clinical protocols, interaction with the regulatory authorities, statistical data management and PK studies
• Ensure that appropriate objectives are met and that Company resources are effectively deployed to meet strategic product development plans
• Build and maintain key opinion leader relationships
• Serve as the clinical lead for advisory meetings
• Liaise with multiple contractors and internal stakeholders, including manufacturing operations, CROs and business development
• Be knowledgeable about current developments in the field in both competitive and complimentary products, technologies and companies.
• Support the development of company and product positioning for investors, analysts, partners, and clinicians
Desired Skills and Experience
An MD or MD/PhD, the Chief Medical Officer will have 10 to 15 years of experience in a pharmaceutical or biopharmaceutical company, leading the clinical development of drug candidates from pre-clinical activities through clinical trials and successful product approval(s). The candidate should have a hematology/oncology focus and should have experience in working with the FDA, clinicians, and investors. Additionally, the Chief Medical Officer should have significant experience in supervision of projects and time-lines and interpretation/evaluation of clinical data. The Chief Medical Officer must also have intimate knowledge of FDA/EMEA requirements and good clinical practices.
The Chief Medical Officer will be a determined executive with strong interpersonal skills, comfortably integrating into a senior-level, high profile role and able to achieve results. Must be hands-on and detail-oriented, while still being able to see the big picture. Must be passionate about stem cell medicine and regenerative medicine. He or she will be motivated by the opportunity to be part of a team, efficiently designing and conducting clinical trials that meet regulatory and commercial requirements. A self-motivated, approachable, articulate team player, the Chief Medical Officer, will have the highest level of integrity and core value system that are consistent with the organization as a whole.
Commensurate upon experience. Pre-IPO company, 3-6 month’s deferred executive pay, equity position. Willingness to become a partner in a fast-growing, entrepreneurial company is preferred.