Global Medical Affairs Leader (GMAL), Global Public Health- HIV at Johnson & Johnson

Role description

The Global Medical Affairs Leader (GMAL) for HIV will provide exceptional clinical and strategic leadership in the therapy area within GPH from pre-launch through the lifecycle of assigned products/health solutions. He/she will develop global medical perspectives, strategies, and will lead the execution of medical plans in close partnership with global, regional and country medical teams. As an integral member of the HIV Access Strategy and Impact team and relevant Disease Area Teams, he/she will be accountable for the execution of the global medical affairs plan that reflects prioritized GPH needs and in alignment with the overall Compound Development Plans. In addition, the GMAL will be accountable for the GPH/HIV publications plans, opinion leader relations, medical education and advisory boards for assigned products. The GMAL will also facilitate and ensure a consistent approach to Medical Affairs processes.

Responsibilities Include
GPH HIV medical strategy and execution:

• Develop GPH medical affairs strategy and plans based on prioritized regional/OpCo needs, working with internal business partners including the product responsible CDTs, ensures integration with global compound strategy, resulting in one R&D and Medical Affairs lifecycle management plan.
• Provides medical/scientific insights to activities related to planning, execution and reporting of Phase IIIB-IV and non-interventional studies without regulatory impact while ensuring timely delivery.
• Responsible for medical affairs activities such as advisory boards, symposia and congress activities.
• Ensure a “unified” medical affairs voice within the HIV Access and Strategy Team
• As part of the Disease Area Team, participate in the development of TPPs and Clinical Development Plans.
• Collaborate closely with the regional and country teams to develop coordinated strategies and plans.
• Oversee GPH HIV publications planning process including manuscripts, abstracts, and posters
• Lead key opinion leader communications & speaker development in the GPH landscape.
• Develop/contribute and review presentation materials for study/program-related advisory boards, investigator meetings, protocol training meetings as the need arises, and act as medical key contact point for assigned MA studies
• Provide ongoing review of clinical study data, final analysis and interpretation, in collaboration with the relevant global teams (SMT, Clinical Teams, CDT)
• Serve as a disease area scientific and medical resource for internal audiences
• Responsible to ensuring that all activities follow J&J Compliance principles, eg. Health Care Compliance, etc.
   

Qualifications

• M.D. or PhD/PharmD is required with experience and/or specialty training in HIV or infectious diseases preferred.
• A minimum of 5 years of combined meaningful experience in a medical/clinical environment and/or scientific function in the pharmaceutical industry is required, with at least 2 years in the Medical Affairs highly preferred
• A proven track record leading highly cross-functional work environments comprised of high-level executives is required.
• A demonstrated track record of success within Medical Affairs and/or clinical R&D.
• Proven ability to partner cross- culturally/regionally.
• Understanding of clinical research methodology, study data reviews and analysis.
• Excellent knowledge of study execution including safety management and regulatory requirements
• Ability to navigate a complex and evolving environment and effectively resolve issues.
• Experience developing and managing relationships with thought or opinion leaders.
• Champion high standards of compliance, ethics and patients safety, putting patients at the center of all actions