Department: Clinical

Head of Medical Affairs

Summary:

The Global Leader, Medical Affairs will have a broad role, with primary responsibilities encompassing the unique Medical Affairs activities associated with developing world infectious diseases.  This is a new role at TB Alliance.  These activities include relationship development with KOLs and other individual and organizational stakeholders, including commercial partners and relevant public health, government, and donor entities.  The candidate will participate in late-stage and post-approval clinical research strategy and design, focused on generation of data relevant to the needs of diverse patient populations.  S/he will report to the Chief Medical Officer, will be a member of the R&D Leadership Team, a member of the Pretomanid Program Team, and participate in other internal cross-functional teams.  S/he will play a key role in helping to establish the scope and policies of the Medical Affairs function and will collaborate closely with internal and external stakeholders. This role will have a strong outward facing presence in the relevant stakeholder communities, including TB researchers, public health treatment policy influencers, TB advocates and patients, academic and public health/country TB treatment program communities.  Ideally, the candidate will have had drug development experience and will also be able to participate in the development of new regimens with investigational drugs to treat TB.

Position description:

  • Build the overarching medical affairs function and strategy for working with public health agencies, commercialization partners, the TB treatment community, key opinion leaders, and other stakeholders to bring TB Alliance approved regimens to the target populations who can benefit, and to provide expert scientific advice and information to external parties.
  • Be an active participant with the R&D leadership team on the strategic development of new regimens and make key contributions to the company’s overall scientific and post approval strategy.
  • Provide medical/clinical expertise and rapid responses to enquiries to internal (Market Access, External Affairs and others) and to external (healthcare professionals, Public Health departments, patients, advocacy groups, etc.) customers.
  • Develop partnerships to help assure patients have Access, Availability, and Affordability of approved products.
  • Establish scientific aspect of the corporate communication strategy for interaction with thought leaders, medical communications and publications plans, scientific congress activities, medical education programs, patient advocacy groups, government entities, and scientific advisory boards.  Contribute to advocacy plans and participate in their execution, including activities to build support for TB Alliance regimens and gather feedback to incorporate into R&D and Market Access planning.
  • Ensure all activities are compliant with global, regional and local regulations, with appropriate processes and documentation.
  • Establish and oversee process, in collaboration with key partners, for the review, approval and tracking of Investigator Initiated Trials/Projects
  • Support the TB Alliance Market Access goals with therapy area and drug/regimen related training and educational modules and conduct high impact trainings such as those of trainers and commercial partners.
  • Develop and manage budgets required to implement Medical Affairs plans.
  • Design, establish and help maintain external advisory committees to support the breadth and global reach of the company’s portfolio, in collaboration with TB Alliance External Affairs and Market Access.
  • Develop and manage clinical advisors relevant to the Medical Affairs Function.  Assist in the selection of outside experts and maintain key relationships of mutual interest around post marketing clinical trials, guidelines, and advisory boards.
  • Develop and deliver scientific and medical presentations, collaborate with partners in medical advisory boards, participate in investigator meetings, and identify relevant medical meetings and congresses and determine appropriate participation.
  • Collaborate with TB Alliance R&D colleagues in the development of new drug regimens with investigational drugs that will lead to regulatory approvals for marketing.
  • Responsible for compliance with applicable GxP regulations in performing the functions of the job and attendance at annual GxP or other applicable regulatory trainings provided by the TB Alliance.

Ideal candidates will have:

  • MD, DO, or equivalent, or PharmD or PhD
  • Preference for training and/or industry experience in infectious diseases and/or public health
  • Significant and progressive experience in medical affairs or equivalent role, preferably in a global or public health setting. Pharmaceutical industry and clinical development experience highly desirable.
  • Experience with drug development in an R&D setting is desirable.
  • A passion for global health required.
  • Experience building relationships externally and internally, conducting scientific presentations and building support with external opinion leaders is essential.
  • Strong analytical skills, especially with regard to understanding and interpreting scientific and clinical research and literature are essential.
  • Experience working with public health agencies, patient advocates and activists is desirable.
  • Experience working with the implementation of new therapies through public health programs in low and middle income countries is an advantage.
  • Team player with an outstanding record of developing collegial relationships with external parties, and in negotiation, problem-solving, and strategic influencing skills.
  • Highly developed written and verbal communication skills, including ability to effectively articulate highly technical/complex scientific data and concepts to audiences with differing scientific and technical knowledge.

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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