Chief Medical Officer
Our client is a drug discovery and development company. They have asked us to assist them in their search for a Chief Medical Officer
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Develops and leads the clinical strategy for the company’s lead drug candidates and novel multidrug regimens in development.
- Leads the planning, designing and execution of clinical trials.
- Oversees protocol development, specifying research objectives, patient recruitment and treatment allocations, study procedures and end points, from Phases 1 through 4.
- Leads the clinical group in identifying and selecting qualified clinical investigators and suitable sites to perform studies.
- Expands the company’s foundation and clinical development capabilities to enable clinical trials in endemic countries.
- Oversees the Medical Affairs function to meet the needs of the organization and external stakeholders.
- Supervises and mentors the company’s clinical staff, including study physicians, pharmacovigilance, medical affairs, and clinical operations staff; identifies and addresses development needs and gaps in resources and/or expertise.
- Provides oversight to the Clinical Operations function, ensuring achievable project targets and timetables, sufficient personnel and financial resource planning, and successful execution of trials.
- Oversees the selection, oversight, and direction of CROs.
- Works effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans and with internationally accepted regulatory, quality, and ethical standards.
- Establishes statistics and data management requirements and ensures appropriate outsourcing to meet these requirements for each clinical trial.
- Oversees pharmacovigilance activities and ensures compliance with all applicable regulations.
- Plays a vital role in the development of criteria for and participating in go/no go decisions on clinical candidates advanced out of discovery or in-licensing opportunities.
- Effectively partners with other members of the leadership team on organizational culture, capacity, and long-term strategy to ensure the organization delivers on its goals.
- Builds and retains talent and capabilities across the functions and teams to ensure the high performance of the organization, as well as leadership and advancement of the field.
- Ensures that clinical trials and development plans provide for robust regulatory strategies designed to expedite FDA and international approvals of new products. Develop effective interactions and cooperation with regulatory authorities worldwide.
- Helps represent the company externally in scientific, financial and business development communities and in meetings with regulatory bodies.
- Stays current on progress in relevant treatment R&D and in development of multidrug regimens.
- Builds, maintains, and oversees relationships with key domestic and international clinical trial groups, collaborators, and funders.
- Responsible for compliance with applicable GxP regulations in performing the functions of the job, and for completion of applicable regulatory trainings.
- Medical degree required.
- Board certification in Internal Medicine with subspecialty training and certification in either Pulmonary or Infectious Diseases highly preferred.
- A minimum of 10 years of direct industry experience in designing clinical development programs and running clinical trials, ideally using external resources, with a strong understanding of the planning and management of clinical trials for new compounds.
- Requires experience in global health would be ideal, including working knowledge of WHO, national agencies, and conduct of clinical trials in developing countries.
- Experience in multiple therapeutic areas and stages of development required.
- Experience in both large and small pharma/biotech highly preferred.
- Requires the ability to be a strategic thinker and a tactical implementer.
- Must have the demonstrated ability to develop, monitor and manage budgets.
- Proven communication skills both written and oral required.
- The ability to present data in a frank and straight forward manner to a variety of audiences is required.
- Must use good judgment and demonstrate a sense of appropriateness.
- Requires the ability and desire to work well with others including those from other cultures and backgrounds.
- Proven analytical and problem-solving abilities required.
- Must be able to effectively prioritize and execute tasks in a complex environment.
- Requires have the ability and strong desire to “roll up their sleeves and work to make things happen.”
- Must be an effective leader, people manager and a team builder.
- Must be willing to travel as required, mostly internationally, to facilitate collaborations, and manage the clinical trial process, contractors, government entities, field personnel, etc.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.