Department: Clinical

Senior Medical Officer

Summary:

The Senior Medical Officer, Clinical Development will be a key member of the TB Alliance Research and Development team and provide expertise necessary to develop strategy for clinical development programs, and organize and manage clinical trials of promising anti-tuberculosis drugs.  

Position description:

  • Contribute to the clinical strategy for the TB Alliance’s drug candidates and novel multidrug regimens in development. Develop effective clinical development plans for clinical candidates and novel regimens.
  • Plan, design and direct clinical trials. Ensure the efficient and effective progress of protocol development - specifying research objectives, patient recruitment and treatment allocations, study procedures and end points - from Phase I through IV.  Identify and select appropriate clinical investigators to perform studies.
  • Help build the TB Alliance’s foundation and clinical development capabilities in tuberculosis endemic areas, for example, Africa, Southeast Asia and South America, where late stage clinical trials will be held.
  • Define, together with the Head of Clinical Operations, project targets and time tables and assess resource requirements, both personnel and financial, to ensure feasibility of the TB Alliance’s clinical development plans.
  • Ensure that all clinical trials conform with internationally accepted standards of good clinical practice and good laboratory practice.
  • Establish statistics and data management requirements for each clinical trial. Ensure adequate outsourcing to meet these requirements and track progress during the conduct of the trials.
  • Oversee progress of ongoing clinical trials to ensure that the TB Alliance’s resources are being put to best use and that the project will meet all critical success factors; prepare materials for interim and formal project reviews.
  • Develop effective interactions and cooperation with regulatory authorities worldwide.
  • Represent the TB Alliance externally in scientific, financial and business development communities and in meetings with regulatory bodies.
  • Help select, oversee and direct CROs and work effectively with partner organizations to conduct clinical trials in accordance with the clinical development plans, cGCP/GLP, and applicable regulatory requirements.
  • 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. Travel as required to facilitate collaborations, and manage the clinical trial process, contractors, government entities, field personnel, etc. International travel is an integral element of this position.
  • Interface with key domestic and international TB clinical trial groups, collaborators and funders.

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 five 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.  Some experience conducting trials in the developing world desired.
  • Some experience with pediatric development plans highly desired.
  • Experience in both large and small pharma desired.
  • A hands-on approach to designing and overseeing clinical trials.
  • The ability to be a strategic thinker and a tactical implementer.
  • A significant amount of travel to the developing world is required.

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.

Our Pipeline

TB Alliance manages the largest pipeline of new TB drugs in history.

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