Medical Director, Drug Development Group

Tracking Code

5305

Job Description

PATH is an international nonprofit organization that transforms global health through innovation. We take an entrepreneurial approach to developing and delivering high-impact, low-cost solutions, from lifesaving treatments, vaccines and devices to collaborative programs with communities. Through our work in more than 70 countries, PATH and our partners empower people to achieve their full potential.

PATH’s Drug Development Global Program grew from our affiliation in late 2011 with the nonprofit drug development group OneWorld Health. We’re working to discover, develop, and deliver safe, effective, and affordable new treatments for diseases disproportionately affecting people in the developing world. By combining entrepreneurial energy, pharmaceutical expertise, and an innovative product development partnership model, we challenge the assumption that pharmaceutical research and development is too expensive to create the new medicines that the developing world desperately needs.

The Medical Director provides scientific direction and clinical oversight for the Drug Development Global Development (DRG) clinical programs.  Under the direction of the DRG Program Leader, s/he will provide scientific and clinical strategic guidance and participate in the design of clinical development plans to support product registration, leveraging the inputs from our current panel of clinical advisors and consultants.  The Medical Director must have a comprehensive understanding of ICH/GCP requirements, principles, concepts, industry practices, and standards and is responsible for the medical oversight of OWH clinical trials.  In addition, the Medical Director will be involved with the evaluation of potential opportunities and external communication with key stakeholders outside of OWH. Essential duties and responsibilities include:

• Serves as Responsible Project Manager for the upcoming HIV PrEP project, including responsibility for the over-all management of the grant and of the partnership.
• Leading the HIV PrEP project.
• Safety monitoring and surveillance.
• Development or input into clinical documents (protocols, investigator brochures, case report forms, etc.).
• Develops global clinical development plans,
• Supervises Clinical Research Associate to monitor ongoing clinical trials.
• Provides medical safety surveillance; responsibilities include development of safety plans, review of study safety data to interpret trends, review of safety submissions to regulatory agencies, updates to investigator brochures or package inserts, coding of adverse events, and training of clinical staff.
• Develops collaborative relationships with key experts and investigators and synthesizes clinical data.
• Provides strategic clinical direction to the various DRG project teams.
• Serves as clinical lead for discussions with regulatory agencies.
• Develops clinical studies that comply with good medical research standards and meet project plans.
• Assists with protocol feasibility assessments for studies conducted in the developing world.
• Serves as medical monitor and clinical advisor with internal staff, investigators, and study site staff.
• Provides medical input into the evaluation process for potential opportunities.
• Interacts with funders on medical issues relevant to current and future programs.
• Works with corporate communications on external affairs to key stakeholders.

Required Skills

• Basic understanding of scientific and clinical concepts and their relevance to clinical research.
• Demonstrated sound knowledge of clinical pharmaceutical standards, ICH/GCP guidelines, regulatory compliance, and relevant experience in clinical aspects of submissions to health authorities.
• Proven ability to foster a collaborative team environment.
• Excellent interpersonal skills with ability to mentor and support colleagues both in headquarters and developing countries.
• Excellent written and oral communications skills.
• Willingness to travel up to 20% of the time.
• Expertise in HIV treatment and prevention preferred.

Required Experience

M.D., with completion of residency in either internal medicine or pediatrics, as well as five to ten years of clinical development experience in the pharmaceutical, biotech industries, or Contract Clinical Research Organization (CRO).  Either training or experience in infectious diseases and HIV AIDS preferred.  Experience interacting with global regulatory agencies is a definite advantage.

PATH is dedicated to diversity and is an equal opportunity employer.

Job Location

South San Francisco, CA, US.

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