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. We're treating cancer, one patient at a time. Join us and make a difference every day.
In compliance with applicable New York and New Jersey State regulatory authorities, COVID-19 vaccination (2 doses of either the Pfizer or Moderna vaccine or one dose of the Johnson & Johnson vaccine) is mandatory for all MSK employees, contingent workers, and volunteers. Exceptions are permitted for those employees who request and receive an approved medical or fully remote exemption.
*Staff working at a MSK New Jersey location must be up to date with COVID-19 vaccination, which includes having completed the primary COVID-19 vaccination series and booster once eligible as mandated by New Jersey State. All New Jersey staff not yet eligible for a booster must receive a booster within 3 weeks of becoming eligible as a condition of continued employment at MSK.
Note: Individuals are eligible to receive a COVID-19 booster five months after receiving the second dose of either the Pfizer or Moderna vaccine or two months after the J&J vaccine.
The Office of Technology Development (OTD) is seeking a Senior Manager, Toxicologist to join our exciting team!
The Office of Technology Development's (OTD) mission is to ensure that Memorial Sloan Kettering's (MSK) inventions have the greatest chance of being developed and commercialized - so that these inventions both benefit patients and return the most value to MSK.
The Senior Manager-Pharmacology and Toxicology plays a major role in this mission by leading pre-clinical pharmacology and toxicology studies of development pipeline products to be conducted at the right time and stages in scientifically rigorous manner and preparing related IND dossiers for IND submissions.
Server as a Subject-Matter-Expert, be responsible for formulating strategies for non-clinical IND enabling studies, and Influence internal and external stakeholders
Plan, draft and lead preparation of non-clinical data packages and relevant sections for new IND submissions or be additional resource to support these activities.
Review and evaluate non-clinical data to determine the appropriate tabular and textual formats for clarity, logic, and order of presentation in IND dossier
Draft and review summary sections for IND dossier
Provide advisory services to the Product Development Team and Principal Investigators (PI) to develop compound(s) in an efficient and timely manner.
Ensure IND enabling studies are conducted at the right time and stages of development, and in scientifically rigorous manner to meet expectations of regulatory agencies.
Work with clinical PI to ensure that the clinic protocol is aligned with non-clinical data and regulatory plan.
Be an expert writer for non-clinical documents that are consistent with FDA and ICH guidelines.
Review work of other writers (in-house or contract) for accuracy, quality, focus and adherence to format and stylistic requirements to ensure high quality documents.
Mentor and coach junior pharmacology and toxicology colleagues
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 carrying out communications based on that understanding.
Adept at creating partnerships and working collaboratively with others to meet shared objectives and goals
Willing to take action and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy and enthusiasm
4+ years of experience and in-depth knowledge in non-clinical toxicology, pharmacokinetics, and/or pharmacology
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
Proficient knowledge of current federal regulations defined by the FDA, ICH, and EMA on products for human use.
Excellent technical scientific writing and verbal communication skills required
The ability to work with multiple complex projects and within cross-functional teams
We offer an outstanding compensation package, healthcare benefits, and retirement saving plan. Apply today and find out more!
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.
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.