Senior Scientist, Drug Development Program (8288) - San Francisco, CA | Biospace
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Senior Scientist, Drug Development Program (8288)

PATH

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Location:
San Francisco, CA
Posted Date:
6/19/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.


PATH’s Drug Development Program (DRG) is working to develop and ensure availability and accessibility of safe and effective new medicines for diseases disproportionately affecting people in developing countries. 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.


PATH is currently recruiting for a Senior Scientist for PATH’s Drug Development Group. The Senior Scientist is responsible for providing guidance and management of clinical pharmacology and toxicology across multiple projects in PATH's Drug Development Group (DRG) and reports to the Director of Research and Preclinical Development. The scientist will direct studies through contract research organizations (CROs) to ensure timely and quality execution. S/he will lead outsourcing processes, and manage relationships with contractors in collaboration with the project manager. In addition, they will work with consultants as necessary for specific projects. The Senior Scientist will write and edit pharmacology and toxicology sections for grant proposals and regulatory filings. Additional responsibilities will include providing scientific and strategic input to project teams and serve as a key member of internal teams evaluating potential new R&D opportunities, and identifying collaborators and funding opportunities.


Responsibilities:
•   Acts as point person for all clinical pharmacology and toxicology activities in the Drug Development Program.
•   Provide scientific and strategic inputs to project teams on product development strategy.
•   Participate as part of the portfolio team to evaluate new R&D opportunities.
•   Prepare, review and edit pharmacology and toxicology sections in grant proposals and regulatory filings.
•   Design and implement key studies including ADME, PK/PD, and toxicology studies to support the development and regulatory filings of drug candidates, working with outside consultants or CROs when necessary.
•   Develop collaborative relationships with key experts and investigators.
•   Interact with funders and outside partners on pharmacology and toxicology issues relevant to current and future programs.

Requirements

•   Minimum of PhD or MD plus 7 years of industry experience or MS plus 12 years
•   Primary expertise in clinical pharmacology
•   Additional expertise in preclinical pharmacology and toxicology
•   DABT a plus but not required
•   Experience in drug development for gastrointestinal diseases or infectious diseases a plus
•   Experience in working with CROs, managing external collaborations and consultants as needed to support project needs
•   Experience in working with U.S. and European regulatory authorities
•   Demonstrated familiarity with FDA, ICH, and GLP guidelines and regulatory compliance
•   Experience in drafting relevant sections of IND and/or NDA submissions
•   Ability to support multiple project simultaneously to work in multi-disciplinary project teams
•   Proven ability to foster a collaborative team environment
•   Excellent interpersonal skills with ability to mentor and support colleagues both in headquarters and in developing countries
•   Excellent written and oral communications skills
•   Willingness to travel up to 15%



Must have legal authorization to work in the United States.

PATH is dedicated to building an inclusive workforce where diversity is valued.

PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.