The Chief Medical Officer will report directly to the Chief Executive Officer. The primary role of the CMO will be to provide leadership and direction for the overall pipeline of clinical development programs in both immune-oncology and ADCs. The CMO will be responsible for the strategy, direction, and execution of the company’s clinical development plans. The CMO will be a key member of the senior management team, serving as a member of the company’s Executive Committee, which determines and oversees research and drug development and sets the overall strategic direction of the company. This is a unique opportunity to be a major contributor to the success of a well-positioned, well-financed growth-stage biotechnology company.
Direct the development of clinical strategies and plans to integrate compounds into the standard practice of ADC and immune oncology development. 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.
Provide clinical support and collaborate 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 investment, medical, and regulatory communities, as well as pharmaceutical or biotechnology industry collaborators/partners.
In addition to leading and supervising the Clinical Research Department, the CMO will have direct line responsibility for the Clinical Operations, Patient Advocacy, Medical Affairs, and Biometrics Departments.
MD with Board Certification in hematology/oncology or Pediatrics with Oncology training preferred.
Minimum of 15 years of experience in clinical practice treating patients and pharmaceutical and/or biotechnology industry experience as a sponsor working on investigational new drugs.
Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical operations.
Proven track record in Phase I-IV clinical research studies and trial design, as well as the successful submission of IND’s and marketing approval-directed filings (BLA’s, NDA’s, and MAA’s).
Knowledge, Skills, and Abilities:
Knowledge of relevant FDA regulations and guidelines as well as those of the EU and other health authorities; experience in interactions with FDA personnel is essential, and experience in interactions with other health authorities is a plus.
Experience with, or strong knowledge of Oncology drug development.
Experience or knowledge of Orphan or genetic rare disease drug development is a plus.
Experience in translational medicine, clinical pharmacology, and early-stage development is desirable.
Excellent knowledge of the competitive environment for drugs in the Hematology/Oncology marketplace and in research and development pipelines.
Thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
Fluent in English with excellent communication skills; capable of articulating 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.
Strong leadership and interpersonal skills; proven ability as an effective team player who can engender credibility and confidence within and outside the company; outstanding executive presence.
Science- and data-driven approach.
Strong desire and ability to “make things happen”.
Results-oriented work ethic and a positive, can-do attitude. Effective leadership, people management, communication skills, and a team builder management style are essential; must be willing and able to be “hands-on”.
Highest personal values and ethical standards.
This is a high-growth, fast-paced small organization. The ability to be productive and successful in an intense work environment is critical. Willingness and the ability to travel domestically and internationally are required; it is anticipated that this will account for 30% of work time.