Chief Medical Officer

The Chief Medical Officer will report directly to the Chief Executive Officer. This position will be engaged in defining and leading the overall clinical strategy, direction and vision of the organization. The successful candidate will lead interactions with regulatory agencies, clinical experts (including KOLs in the field), and work with cross-functional teams to design, develop and implement clinical studies.

This is a unique opportunity to be a major contributor to the success of a dynamic and well-financed growth stage biotechnology company.

• Provide strategic input for innovative clinical development plans, incorporating the current therapeutic area landscape
• Orchestrate and manage clinical aspects of regulatory strategies and interactions with Health Authorities
• Oversee the analysis and interpretation of clinical trial data and the reporting of clinical trial results
• Lead interactions with academic thought leaders, investigators, cooperative groups, and other clinical stakeholders including investigator and clinical advisory boards
• Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy
• Represent the Company and its programs to external audiences, including the medical and regulatory communities, as well as selected investment venues and current and prospective biopharmaceutical collaborators
• Lead and supervise the Clinical Operations, Regulatory, and Quality Control functions

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• History of success progressing therapeutic programs from IND-enabling studies through human proof of concept, and/or from Phase 1 to Phase 3 development or NDA approval
• Multiple years of management experience leading a clinical group including clinical operations, regulatory, and quality control
• Knowledge of relevant FDA regulations and guidelines and other health authorities; experience in interactions with FDA personnel is essential; experience in interactions with other health authorities a plus
• Experience with the design, execution, and analysis of clinical oncology studies with small molecule targeted or immunological therapies
• Experience in translational medicine, clinical pharmacology and early stage development is desirable
• Excellent knowledge of the competitive environment for drugs in the oncology marketplace and in research and development pipelines
• Must have a thorough knowledge of clinical research concepts, practices, and GCP and ICH guidelines
• The successful candidate will possess excellent communication skills and can articulate the Company's clinical and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and the investor community
• Must be science- and data-driven, with an understanding of basic science relevant to clinical oncology
• Ability to work collaboratively in a fast-paced matrix environment

EDUCATION

• M.D./Ph.D. or M.D. with board certification or eligibility in oncology or hematology/oncology is preferred