Our Pipeline
TB Alliance manages the largest pipeline of new TB drugs in history.
Department: Clinical
Senior Director Clinical Development
Summary:
The Senior Director, 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. The Senior Director, Clinical Development reports to the Chief Medical Officer.
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 timetables 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
- 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.
- Responsible for compliance with applicable GxP regulations in performing the functions of the job and completion of applicable regulatory training provided by the TB Alliance.
Ideal candidates will have:
- Pharm D or PhD degree in a science-related field; advanced degree related to Infectious Disease or Virology strongly preferred.
- 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 with large, global trials in the developing world is desired.
- Excellent knowledge of ICH/GCP guidelines.
- Experience authoring clinical sections of regulatory documents (IND Annual Reports/ clinical summary documents for NDA/MAA submissions).
- Some experience with pediatric development plans is 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:
Salary and Benefits:
As part of our overall compensation package, we offer comprehensive health benefits, generous retirement contributions, and work/life flexibility designed to support you and your family.
Starting salary is expected to be in the range of US$280,000 - $350,000 exact salary will be commensurate with skills and experience and adjusted to reflect local currency for candidates outside the US.
Along with a competitive salary, TB Alliance offers superior employee benefits centered on medical insurance with very low co-payments, high levels of coverage, resulting in overall coverage valued at the 95th percentile. The package also includes vision, and dental insurance for employees, spouses, domestic partners, and dependent children, life insurance/accidental death. 100% of employee benefit costs are paid by the organization, with coverage effective day one of employment.
TB Alliance also offers a retirement savings program in the form of a 401k plan with generous employer contributions and employee matching.
Additionally, TB Alliance provides generous paid time-off, paid parental leave, paid family leave, flexible-hybrid work schedules, tuition reimbursement, student loan repayment assistance, as well as professional development opportunities for all staff.
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.