Our Pipeline
TB Alliance manages the largest pipeline of new TB drugs in history.
Department: Clinical
Chief Medical Officer
Summary:
The Chief Medical Officer will be a key member of the TB Alliance Research and Development leadership team, will develop and lead the clinical strategy and provide oversight of clinical trial planning and execution of promising anti-tuberculosis drugs and regimens.
Position description:
- Develop and lead the clinical strategy for the TB Alliance’s lead drug candidates and novel multidrug regimens in development.
- Lead the planning, designing and execution of clinical trials. Oversee efficient and effective protocol development - specifying research objectives, patient recruitment and treatment allocations, study procedures and end points - from Phase I through IV. Lead the clinical group in identifying and selecting qualified clinical investigators and suitable sites to perform studies
- Expand the TB Alliance’s foundation and clinical development capabilities to enable clinical trials in TB endemic countries.
- Oversee Medical Affairs function to meet the needs of the organization and external stakeholders.
- Supervise and mentor TB Alliance clinical staff, including study physicians, pharmacovigilance, medical affairs and clinical operations staff; identify and address development needs and gaps in resources and/or expertise.
- Oversee Clinical Operations, ensuring achievable project targets and timetables, adequate resource planning, both personnel and financial, and successful execution of trials.
- Oversee the selection, oversight and direction of CROs and work effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans and with internationally accepted regulatory, quality, and ethical standards.
- Establish statistics and data management requirements and ensure appropriate outsourcing to meet these requirements for each clinical trial.
- Oversee pharmacovigilance activities, ensuring compliance with all applicable regulations and a robust approach to drug safety.
- Play a key role in developing the criteria for, and participating in go/no go decisions on clinical candidates advanced out of discovery or in-licensing opportunities, and at key clinical development milestones.
- Effectively partner with other members of the leadership team on organizational culture, capacity and long-term strategy to ensure the organization delivers on its goals.
- Build and retain 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.
- Ensure 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.
- Help represent the TB Alliance externally in scientific, financial and business development communities and in meetings with regulatory bodies.
- Stay current on progress in TB treatment R&D and in development of multidrug regimens.
- Build, maintain, and oversee relationships with key domestic and international TB clinical trial groups, collaborators and funders.
- Travel as required, primarily internationally, to facilitate collaborations, and manage the clinical trial process, contractors, government entities, field personnel, etc.
- In all of the above, partner collaboratively with appropriate internal functions across the organization.
- Responsible for compliance with applicable GxP regulations in performing the functions of the job, and for completion of applicable regulatory trainings.
Ideal candidates will have:
- MD required. Ideally, Board certified in Internal Medicine w/subspecialty training and certification in either Pulmonary or Infectious Diseases. However, experience in any of a broad range of therapeutic categories is acceptable.
- A minimum of ten years 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.
- 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.
- Experience in both large and small pharma/biotech would be a plus.
- The ability to be a strategic thinker and a tactical implementer.
- Demonstrated ability to develop, monitor and manage budgets.
- Proven communication skills both written and oral and the ability to present data in a frank and straight forward manner to a variety of audiences.
- Uses good judgment and demonstrates a sense of appropriateness. Demonstrates a high level of integrity. Considers the consequences of personal actions and decisions. Reflects upon and learns from experience.
- Ability and desire to travel internationally.
- Ability and desire to work well with others including those from other cultures and backgrounds.
- Proven analytical and problem-solving abilities.
- Ability to effectively prioritize and execute tasks in a complex environment.
- For best fit, the candidate must have the ability and strong desire to “roll up his/her sleeves and work to make things happen.” The candidate must have a results-oriented work ethic and a positive can-do attitude.
- The successful candidate will be an effective leader, people manager and a team builder.
Location:
New York, NY
Organizational Information:
TB Alliance is a not-for-profit organization dedicated to the discovery and development of better, faster, affordable tuberculosis drugs that are available to those who need them.Through innovative science and with partners around the globe, we lead a global effort to ensure development of and equitable access to faster, better tuberculosis cures that will advance global health and prosperity.
With an annual operating budget of approximately $60 million, the TB Alliance leads the advancement of the most comprehensive R&D portfolio of TB drug candidates in history. Additionally, the TB Alliance drives efforts to ensure regulatory approval, country adoption of new regimens, and widespread availability of new drug regimens to patients. For more information, please access the website: www.tballiance.org.