Chief Medical Officer

We are seeking an exceptional and inspirational individual for this key role, with broad responsibilities for formulating and implementing all clinical development activities. The CMO will support TB Alliance’s mission by leading the CMO function and inspiring the team to bring forward promising anti-tuberculosis drugs and regimens.

• Together with other members of the executive team, play a key role in advancing the strategic and operational goals of the organization.
• Formulate and lead the clinical development strategy for TB Alliance’s drug candidates and novel multidrug regimens, including the integration of nonclinical and clinical activities. Ensure that product development plans are robust from scientific, clinical, regulatory, safety, and quality perspectives.
• Lead the planning, design and execution of scientifically robust and operationally efficient clinical trials from phase 1 through 4, taking into account relevant clinical trial and scientific data, disease knowledge, and applicable innovative technologies.
• Ensure TB Alliance’s clinical development capabilities are well-positioned for conducting clinical trials in TB endemic countries.
• Oversee Medical Affairs function to meet the needs of the organization and external stakeholders.
• Oversee Clinical Operations, ensuring aggressive but realistic project targets and timelines, adequate resource planning, and successful execution of trials.
• Ensure that statistics and data management requirements are met through appropriate outsourcing and that processes are in place for real-time data monitoring where appropriate.
• Oversee ongoing clinical trials for efficient resource utilization, progress towards trial objectives, and emergence of new data and information; guide modifications as appropriate.
• Oversee pharmacovigilance activities, ensuring compliance with all applicable regulations and a robust approach to drug safety.
• Develop effective interactions and cooperation with regulatory authorities worldwide.
• Help represent the TB Alliance externally in scientific, financial and business development venues and in meetings with regulatory bodies.
• Ensure that clinical trial results contribute to regulatory strategies designed to expedite FDA and international approvals of new products.
• 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.
• Provide clinical and scientific input into Research and Early Development activities, including disease education, target identification, lead selection, preclinical pharmacology PoC, nonclinical toxicology, biomarker strategy, and IND enabling studies to develop optimal translational medicine approaches to facilitate development to clinical PoC.
• Ensure smooth transitioning of development candidates/programs from research through development and into commercialization.
• 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.
• Drive internal and external collaboration by continually seeking and implementing innovative solutions; create a culture that thrives on progress and results.
• Establish a culture of integrity, transparency, respect, professionalism and meaningful, effective communication.
• Travel as required, primarily internationally, to facilitate collaborations, and manage the clinical trial process, contractors, government entities, field personnel, etc.
• Responsible for compliance with applicable GxP regulations in performing the functions of the job and completion of applicable regulatory trainings provided by TB Alliance.

• MD required. Ideally, Board-certified in Internal Medicine, subspecialty training and certification desirable, preferably in Pulmonary or Infectious Diseases. However, experience in any of a broad range of therapeutic categories is acceptable.
• PhD in relevant scientific discipline, or significant medical or scientific research background…