Company Overview

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.

Job Description

The Office of Technology Development (OTD) is seeking a Senior Pharmacology / Toxicology Associate to join our exciting team!

At MSK, extraordinary teams of scientists and clinicians work together on groundbreaking research which can lead to new cancer diagnostic and therapeutic inventions. The OTD's mission is to ensure that these inventions have the greatest chance of being developed and commercialized - so that these inventions both benefit patients and return the most value to MSK.

You Will:

• Provide advisory services to the Product Development Team and Principal Investigators (PI) to develop compound(s) in an efficient and timely manner following standard methodologies.
• Be a Subject-Matter-Expert in designing non-clinical IND enabling studies to ensure programs are conducted at the right time and stages of development, and met expectation of regulatory agencies.
• 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 in IND dossier.
• Be an expert writer for non-clinical documents that are consistent with FDA and ICH guidelines.
• 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 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 to ensure high quality documents.
• May be assigned to mentor junior PhD level associates.

You Are:

• 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

You Have:

• 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!

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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.