Preclinical Project Manager- New York City
Location: New York, NY
Name: Arra Lam
Preclinical Project Manager- New York City 10005
The incumbent serves as Project Manager, reporting directly to the Chief Scientific Officer, and is responsible for the day-to-day management of multiple outsourced research and development project
- Develop RFP and manage recruitment of contract research services provided by CRO-type organizations
- Coordinate with the CRO the preparation of an integrated product development plan that includes scope, time, resources, and major steps of development, supported by a Gantt chart, for each project within the program
- Monitor and oversee all CRO activities, liaising directly with CRO Project Management
- Estimate and coordinate resources with the Project Lead and to understand and execute project in context of overall program
- Manage team members and leverage additional expertise to achieve goals
- Ensure successful delivery of program milestones in a timely, cost-effective, and high quality fashion (including de-risking the candidate and investments as early as practical)
- Ensure technical review and drive overall due diligence for the program
- Coordinate activities between all relevant parties and other experts (if relevant)
- Coordinate and contribute to the preparation of ad-hoc, monthly and annual reports; and development of project-related briefings and presentations
- Act as point of contact and project representative to governance and other decision-making bodies, including information dissemination and the resolution of critical project issues
- Act as point of contact to funding organization(s) (e.g., BMGF), providing funder(s) with high quality reporting of activities at predetermined intervals; maintain tracking tools for communication with funders
- Lead analysis of risks, opportunities, and changes during development
- Coordinate and contribute to the implementation of corrective actions and risk mitigation plans; assist in establishing criteria for decision-making
- Develop and/or implement utilization of project management tools and methodologies, including adoption of databases, as needed
- A Ph.D. in chemistry and pharmaceutical science or related disciplines from a well-respected academic institution is required.
- 5+ Years of working experience in a research and development capacity within a pharmaceutical/biotechnology company.
- Experience in CMC with a thorough understanding of the requirements and processes needed to take a potential drug candidates from discovery into development and registration. An ideal candidate should be an expert in one specific area of CMC, such as process chemistry, manufacturing and formulation development, but have broad exposure in other aspects of CMC. A broad knowledge base in drug discovery, preclinical and clinical development and experience with both discovery and development programs.
- Broad exposure to product development with an understanding of the complex interface between research and clinical development.
- Familiarity with regulatory guidelines governing the chemical, pharmacological, pharmacokinetic and toxicological aspects of a successful IND.
- Strong communication, presentation and interpersonal skills with the ability to build effective working alliance.
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
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