The position will be based in Pretoria and reporting to the Chief Medical Officer, the Head of the South African Office will be an integral member of the Research and Development leadership team. Aim of the PositionWe are aiming to integrate fully the USA and Pretoria offices into one clinical development organization. The successful candidate will provide expertise necessary to develop strategy for clinical development programs and to organize and manage clinical trials of promising anti-tuberculosis drugs around the globe, but bringing to the organization particular expertise in the African regionPosition ResponsibilitiesWork with the CMO and Sr VP, RD to develop clinical and regulatory strategy, lead the development of effective clinical development plans for clinical candidates and novel regimens, and lead the execution for approval of the clients drug candidates and novel multidrug regimens around the globe, but with particular expertise in the African region.Work with the CMO to lead the planning, designing and directing of clinical trials, particularly in the Africa region. 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.
Work closely with clinical operations to identify, select and manage clinical investigators and sites to perform clinical studies.Act as medical monitor for the clients clinical trials.Help build the clients foundation and clinical development capabilities in tuberculosis endemic areas, for example, Africa and Southeast Asia, where late stage clinical trials will be held.Work with the Head of Clinical Operations to define project targets and time tables and assess resource requirements, both personnel and financial, to ensure feasibility of the clients clinical development plans.Ensure that all clinical trials conform to internationally accepted standards of good clinical practice and good laboratory practice.Oversee progress of ongoing clinical trials to ensure that the clients 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.Work with the CMO and Sr VP, RD to develop effective interactions and cooperation with regulatory authorities worldwide, but particularly in the African region.Represent the client externally in scientific, financial and business development communities and in meetings with regulatory bodies.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, 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 RD 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.Be seen as a welcome face of The client clinical and interface with other parts of the client as well as its stakeholders, including funders, pharma partners, the academic community, national treatment programs, and global health organizations.Administratively manage the Pretoria office.Minimum RequirementsMedical Doctor 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 conducting trials in the developing world, including Africa.Experience in multiple therapeutic areas and stages of development.Experience in both large and small pharma.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 straightforward 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.Please note that only shortlisted candidates that meet the relevant criteria will be contacted. Should you not be contacted please note that you application has thus not been shortlisted.