Pharmacology and Toxicology Scientist
At Memorial Sloan Kettering (MSK), we’re not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we’re driving excellence and improving outcomes.
For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker’s Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor’s Employees’ Choice Best Place to Work for 2018. We’re treating cancer, one patient at a time. Join us and make a difference every day.
Pharmacology and Toxicology Associate
- Provide advisory services to the Product Development Team and Principal Investigators (PI) to develop compound(s) in an efficient and timely manner following best practices
- Design non-clinical IND enabling studies to ensure programs are conducted at the right time and stages of development
- Work with clinical PI to ensure that the clinic protocol is aligned with non-clinical data and regulatory plan
- Participate in submission team meetings and manage and drive timelines for non-clinical portions of submissions
- Review and evaluate non-clinical data to determine the appropriate tabular and textual formats, clarity, logic, and order of presentation
- Be an expert user of the templates for non-clinical documents that are consistent with FDA and ICH guidelines and with electronic submissions guidelines
- Participate in study and project team meetings and assist the teams in resolving issues related to document preparation
- Work with IND office to initiate and maintain electronic study report and published literature repository, and contribute to the authoring, review, and approval process for documents within an electronic publishing system
- Attend Product Development Team meetings and Department Group Meetings as needed to develop understanding of upcoming needs for non-clinical writing
- Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements in order to ensure high quality documents
- Detail-oriented and flexible in your approach; as demonstrated in your work, correspondence and written communication
- A professional who is comfortable working closely with others including senior faculty and staff
- An effective communicator, capable of determining how best to reach different audiences and executing communications based on that understanding
- Adept at creating partnerships and working collaboratively with others to meet shared objectives and goals
- Action-oriented and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm
- Bachelor’s degree in a scientific-related discipline with significant work experience required. Related Master’s degree or PhD/PharmD/DVM preferred.
- Must have outstanding expertise and in-depth knowledge in non-clinical toxicology, pharmacokinetics, and/or pharmacology, with demonstrated proficiency in authoring sections of Investigational New Drug Application
- Demonstrated knowledge of regulatory requirements of study types assigned, as well as Testing Facility SOPs and the Good Laboratory Practices (GLPs), as appropriate
- Maintain proficient knowledge of current federal regulations defined by the FDA, ICH, and EMA on products for human use. 21CFR 4, 58 (GLP), 201, 210, 211, 212, 312 (IND), 315 (Radiopharmaceuticals), 316, 600-610 (Biologics), 630 (Blood Products), 809 (IVD), and 812 (IDEs)
- Excellent technical scientific writing and verbal communication skills required
- Ability to work with multiple complex projects and within cross-functional teams
- Experience with electronic document submissions (eCTD) for FDA preferred
- Proficiency in use of Microsoft Word, Excel, Adobe Acrobat, and web-based browser software such as LiveLink to manage electronic document authoring, reviewing, and approval process
- Experience with MS Project a plus
- Knowledge of the Standard for Exchange of Non-clinical Data a plus #LI-POST
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
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