Job Description

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.

Position Responsibilities:

• 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.

Requirements:

• 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 preferred.
• Significant industry experience in scientific and operational leadership of multiple clinical development programs and clinical trials with direct or matrixed responsibility for functional areas critical to successful drug development, i.e., pharmacology, pharmacometrics, statistics, preclinical safety, CMC, regulatory, project management, finance, etc.
• Experience in global health would be a plus, including working knowledge of WHO, national agencies, and conduct of clinical trials in developing countries.
• Experience in all stages of development, and preferably multiple therapeutic areas.
• Experience in both large and small pharma/biotech would be a plus.
• Ability to effectively prioritize and execute tasks in a complex environment.
• Possess excellent oral and written communication skills; capable of articulating the Company’s clinical development and regulatory strategies and progress to a wide audience including the CEO, the Board of Directors, Company employees, and external audiences
• Proven analytical and problem-solving abilities.
• The ability to be a strategic thinker and a tactical implementer.
• Demonstrated ability to develop, monitor and manage budgets.
• 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 and have the ability to collaborate with others including those from other cultures and backgrounds.

Organizational Information:

TB Alliance is the recognized leader in accelerating the development and adoption of urgently needed new anti-tuberculosis (TB) drugs. The transformative BPaL/M regimens have become the gold standard for drug-resistant TB treatment, available at affordable pricing in more than 150 countries worldwide and approved by regulatory agencies in 28 countries.

TB continues to cause more deaths worldwide than any other infectious disease and disproportionately impacts marginalized populations as the disease is concentrated in lower- and middle-income countries and in patient populations in the lowest economic strata. The World Health Organization (WHO) reports an estimated patient population of 10 million annually with active TB, of which 410,000 have drug-resistant forms of the disease. In addition, over 1.5 billion people are infected with the TB bacillus, forming the reservoir for the development of active TB.

Despite the high degree of unmet need worldwide, lack of commercial viability severely limits commercial interest in this disease area and treatment improvements are largely dependent on financial subsidization through public sector and private sector funding. TB Alliance was established to fulfill the need for greatly improved TB treatment, deploying a unique not-for-profit operating model characterized by a small core of highly experienced internal staff with capabilities extending across the Research & Development spectrum through to achieving widespread access to improved TB drugs. The TB Alliance has a global footprint and an annual operating budget of approximately $100 million, including ~$45M in negotiated leverage funding.

Compensation and Benefits:

As part of our overall compensation package, we offer a competitive salary, comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support employees and their immediate family. Starting salary is expected to be in the range of US$425,000 – $525,000, exact salary will be commensurate with skills and experience and adjusted to reflect local currency for candidates outside the US.

Instructions:

Interested candidates may submit resumes to our executive search partners at info@fcgsearch.com

Terms and Conditions:

Position based in New York City, NY (US), with the incumbent ideally located within commutable distance. Other relevant locations may be considered. A flexible, hybrid schedule is available; domestic and international travel will be required.

TB Alliance is an Equal Employment Opportunity employer. This job description should not be construed to imply that these requirements are the only standards for the position. Other duties may be assigned. TB Alliance has the right to revise this job description at any time. TB Alliance is an “at will” employer and as such, neither this job description nor your signature constitutes any form of contractual arrangement between you and TB Alliance.

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