Director, Clinical and Medical Affairs, HIV and AIDS Program

The Population Council is an international, nonprofit, nongovernmental organization that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources.

The goal of Population Council’s microbicides program is to develop and introduce safe and effective microbicides for vaginal and/or rectal use to prevent transmission of HIV and other sexually transmitted infections. The Council's comprehensive approach to microbicides development comprises all aspects of research, from the laboratory to the field, product introduction, and public education. Council researchers are developing a next generation of microbicides with new formulations and mechanisms of action, including protection against other sexually transmitted infections and prevention of pregnancy. Complementary research seeks to increase adherence to product use, improve reporting of adherence and sensitive behaviors that have an impact on study outcomes, identify more effective methods for recruiting the most appropriate study populations, and improve the informed consent process. Pre-Phase 1 through Phase 3 clinical trials are supported by a multi-disciplinary team to test the safety and efficacy of candidate microbicides prioritized through product development. Research on clinical trial design aims to improve adherence and reporting of adherence in the clinical trial setting.

The Director, Clinical and Medical Affairs, HIV and AIDS Program, is responsible for overseeing the clinical testing of Population Council microbicides, as well as clinical aspects of ongoing methodological studies designed to improve the conduct of clinical trials. This will involve the collaboration with offsite domestic and international clinical sites. He/She will manage the microbicides clinical team, directly supervising the roles of Clinical Project Manager and Statistician. He/She will work closely with the Senior Scientist/Director of Biomedical HIV Research and the biomedical researcher team to advance product development and pre-clinical testing, and with behavioral researchers on acceptability, feasibility studies. He/She will be expected to provide medical and technical support and oversee clinical trial protocol development. He/She will be expected to share medical/clinical expertise with his/her counterparts in other functional areas such as pre-clinical development, project management, quality assurance, and regulatory affairs. He/She will provide medical and technical perspective to corporate affairs in their efforts to identify potentially promising partnering opportunities, as well as providing global clinical support for other HIV-related clinical projects. He/She will be responsible for seeking and securing funds from government and non-government sources.

Provide clinical leadership and medical expertise to the Microbicide Program and oversee clinical testing of Council microbicides (in collaboration with internal and external colleagues, as appropriate):

1. Direct clinical development of candidate microbicide products, outlining pathway of specific studies necessary for licensure.
   
   • Manage all trial activities from study concept development through final study reports and peer-reviewed publications. Includes designing clinical studies and developing study protocols, case report forms, , and/or other relevant data collection instruments, overseeing statistical analysis and data management plans; providing clinical components of regulatory documents/registration dossier and brand related medical information, clinical communication and publications.
   • Ensure all clinical deliverables meet FDA and other regulatory requirements where required.
     
   • Author, review and approve documents related to clinical matters affecting the preparation and submission of timely and sound information to the FDA.
2. Develop safety plans for clinical trials in collaboration with Medical Safety Team, as needed.
   
3. Ensure all regulatory approvals for clinical trials are secured in collaboration with study teams.
4. Oversee clinical trial data compilation and analysis, as appropriate.
5. Provide representation at national/international conferences and collaborative meetings to support Council microbicides in the global clinical arena, including representation to the FDA.
6. Collaborate with pre-clinical, regulatory, and intellectual asset management teams to optimize new product development for successful launch into the marketplace. Responsible for approvals needed for safety reports, product design, clinical appropriateness review, label copy.
   
7. Work closely with biomedical, social scientists, statisticians and data analysts on the execution of clinical trials needed to advance microbicide development.
   
8. Identify and assist in securing funding opportunities for advancement of microbicide development. Continue and expand ongoing donor relations and contribute to fundraising proposals for microbicides and other HIV/AIDS clinical research.
   
9. Identify potential opportunities for collaboration with external partners.
   
10. Provide clinical support for other HIV and AIDS projects, as requested.

• M.D. Degree with a minimum of 10 years of clinical research experience after completion of residency.
• Medical/scientific expertise in the field of HIV required, with a particular focus in microbicides or HIV/AIDS prevention. Knowledge of other STIs, especially HPV and/or HSV-2, a plus.
  
• Thorough knowledge of Good Clinical Practice requirements essential with minimum of 5 years experience in drug and clinical development.
  
• Knowledge of US FDA requirements and experience in FDA interactions. Additional experience and understanding of European, Indian and/or African regulatory requirements is a plus.
  
• Collaborative team approach essential. Ability to work with multidisciplinary and multicultural developmental project teams.
  
• Excellent diplomatic, problem solving, management, and interpersonal skills.
  
• Excellent written and verbal communication skills, as evidenced by a record of publications and public speaking.
• Proficiency in MS Office, including Word and Excel.
• Ability to travel nationally and internationally a minimum of 25%.