Our client is a French innovative biotechnology company developing a discovery platform to produce next generation allogeneic vaccines against cancer.
The company finalized the preclinical data pack with impressive results for its lead candidate targeting colorectal cancer. A FIH clinical study (PhI/IIa) will start end of 2022 in several countries (France, Belgium and the USA) and the company is on the process to finalize regulatory requirements to conduct this trial.
The company is building a pipeline of additional product candidates targeting other solid tumors indication and is working about potential of its platform on other disease such as infectious disease. The objective is to become an international leader in cancer vaccines and is currently working on its international expansion through worldwide academic collaborations.
The Chief Medical Officer will report directly to the Chief Operational Officer. The primary role of the CMO will be to provide leadership and direction for the company's pipeline of clinical development programs in both genetic rare disease and cancer.
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 as a member of the company’s Executive Committee which determines and oversees research and drug development at the company 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.
To perform this job successfully, an individual must be able to perform the following:
- Direct the development of clinical strategies and plans to integrate the company compounds into the standard practice of oncology disease.
- 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 international academic thought leaders, investigators, cooperative groups, and other clinical stakeholders.
- 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 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 and Medical Affairs Departments and will have to build up through recruitments these departments.
Education/Experience: The ideal candidate will offer:
- MD with Board Certification in Immuno/Oncology
- 15 years minimum 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
- A proven success record in Phase I-IV clinical research studies and trial design as well as the successful submission of IND’s and/or IMPD 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; experience in interactions with other health authorities a plus
- Experience with, or strong knowledge of Oncology drug development
- Experience or knowledge of Orphan or genetic rare disease drug development a plus
- Experience in translational medicine, clinical pharmacology and early stage development is desirable
- Excellent knowledge of the competitive environment for drugs in the Immuno/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 read, write and speak fluent English, possess excellent communication skills and will be 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.
- Must have excellent leadership and interpersonal skills; should have proven skills as an effective team player who can engender credibility and confidence within and outside the company; must have outstanding executive presence.
- Must be science- and data-driven
- For best fit, the candidate must have the ability and strong desire to “make things happen”.
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 ability to travel domestically and internationally is required, it is anticipated that this will be at least 30 % of work time.