Chief Medical Officer
MAIN PURPOSE OF POSITION:
The Chief Medical Officer (CMO) will report directly into the Chief Executive Officer (CEO). The primary role of the CMO will be to provide leadership and direction to the Clinical Research organization. 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 of the company’s Executive Committee.
This position will work within a multidisciplinary team setting to provide clinical expertise and leadership in support of Clinical Research and the development and commercialization of novel therapeutics in multiple therapeutic areas, with a focus on metabolic diseases, nephrology, hepatology, and pain. This is a unique opportunity to be a major contributor to the success of a well-positioned company.
- Lead the development, planning and execution of world-wide clinical trials for our Epigenetic Regulator Program, and other NCE’s.
- o Develop clinical strategies and execute clinical programs including the strategic planning, interaction with clinical advisors, implementation, oversight, and completion associated with each clinical research project.
- Responsibilities include leadership of project-related clinical teams and oversight of clinical data management, drug safety, medical monitoring, and medical writing.
- Perform safety assessments, monitoring clinical data and overseeing the analysis and interpretation of clinical trial data and the reporting of clinical trial results.
- A key decision maker in determining indication selection for product candidates to enter into clinical development.
- Provide clinical support and work with other members of the management team to develop and communicate the overall corporate strategy.
- Oversee portfolio management activities to ensure appropriate objectives and resources are in place to meet strategic goals and ensure the advance of all of the Company's products in development.
- Develop and maintain relationships with clinical advisors, key opinion leaders, and academic institutions for the purposes of business and research collaborations.
- Prepare manuscripts and scientific papers on the Company's products and clinical findings.
- Lead interactions with academic thought leaders, investigators, cooperative groups and other clinical stakeholders. Responsible for delivering clinical protocols, INDs, NDAs and similar documents on-schedule.
- 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.
- M.D. with Board Certification in a therapeutic area consistent with our development portfolio.
- Must have proven track record (i.e., NDA’s, publications) of leadership role in completing clinical trials that have led to U.S. product approval.
- Experience in metabolic disease and internal medicine (nephrology, hepatology) is preferred.
- Broad medical, scientific, regulatory, and technical knowledge of most functional areas involved in drug discovery and the development of clinic bound products.
- Must have thorough knowledge of clinical research concepts, practices, and GCP and ICH Guidelines.
- Experience designing and conducting successful Phase I - III clinical trials.
- Multiple years of management experience leading a clinical group including clinical/medical affairs and clinical
- Experience in translational medicine, clinical pharmacology and early stage development is desirable.
- At least 10 years of relevant industry experience in either the pharmaceutical or biotechnology industries.
- Prior experience in a (global) clinical development and leadership capacity with demonstrated capabilities to lead clinical program(s) to successful filing and approval in both US and global (mainly European) markets.
- For best fit, the candidate must have the ability and strong desire to be “hands on” leader. Must have a results-oriented work ethic and positive, can-do attitude. Effective leadership, people management, communication skills and a team builder management style are essential.
- Must be science-and data-driven.
- Strong analytical skills, as well as strong verbal and written communication skills, with record of publications.
- Must have the highest personal values and ethical standards.
- This is a high growth, fast paced small organization.
- 100% of work is performed in a typical office environment. The ability to be productive and successful in an intense work environment is critical.
- No or very limited exposure to physical risk.
- Willingness and ability to travel domestically and internationally is required. This is anticipated to be 20-30% of work time.
The above job description is not intended to be all-inclusive of the duties and standards of this role.