Experimental Therapeutics Project Manager

USA-NY-New York
1 month ago
Requisition ID
2017-15332
Category
Research - Other

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.

 

For the 27th 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 2016, as well as Glassdoor’s annual Employees’ Choice Awards 2017. We’re treating cancer, one patient at a time. Join us and make a difference every day.

Job Description

We are:

The Experimental Therapeutics Project Manager (ETPM) is a key position in the department’s efforts to ensure that MSKCC investigational products for our clinical trials are developed and manufactured at the highest lest of quality and compliance with external regulatory and inter/intra institutional and departmental requirements.

 

You are:

  • Capable of building strong customer relationships and delivering customer-centric solutions
  • Able to work effectively in an environment notable for complex, sometimes contradictory information
  • A good decision-maker, with proven success at making timely decisions that keep the organization moving forward
  • Action-oriented and eager to embrace new opportunities and tough challenges with a sense of urgency, high energy, and enthusiasm
  • Adept at planning and prioritizing work to meet commitments aligned with organizational goals
  • Consistently achieving results, even under tough circumstances
  • Adept at creating partnerships and working collaboratively with others to meet shared objectives and goals
  • Effective at building formal and informal networks inside and outside the organization to further departmental and institutional goals
  • Flexible in your approach and demeanor in order to align with the shifting demands of evolving circumstances

 

You will:

  • Work with the Principal Investigators to help develop their investigational therapies toward testing in clinical trials, utilizing technical and regulatory knowledge to streamline the product development process toward Food and Drug Administration (FDA) approval.
  • Develops a working knowledge of FDA regulations and guidance relating to the development and manufacture of investigational agents, including 21 CFR parts 210, 211, 312, 600’s, 820, 1271, relevant United State Pharmacopeia (USP) chapters, European Pharmacopeia (EP), and ICH guidelines.
  • Keeps aware and studies new regulations and guidances in a timely manner.
  • Work with Principal Investigators on the contracting pre-clinical research and manufacturing out to suitable CRO’s any steps for any projects that cannot be done in an effective or timely manner in-house.
  • Plan the production schedule within budgetary limitations and time constraints. Ensures manufacture of products on schedule, in accordance with quality standards, and at the lowest possible cost within specific quality specifications.
  • Coordinate communications with outside vendors and MSKCC core facilities regarding drug development and manufacturing strategies, plans, and timelines.
  • Maintain up-to-date knowledge of the relative capabilities and competencies of clinical research organizations and other potential contractors in the areas of product development and formulation, product characterization, non-clinical testing in in vitro and in vivo models, and product manufacturing and testing.
  • Issues batch records, SOPs, reports and labeling in support of drug manufacturing.
  • Performs lot packet creation and review.
  • Assists PI to locate or create technical information needed for regulatory submissions or for other development studies and reports.
  • Keeps track of the amount of drugs manufactured and makes sure that the drug supply in Pharmacy is adequate and will meet demand.
  • Review laboratory-level SOPs, master batch records, testing reports and stability and testing plans for compliance with regulations and institutional policy; works with laboratory to arrive at approvable final version of documents.
  • Maintains knowledge of relevant FDA regulations related to product development and manufacturing, and applies them correctly to MSKCC investigator’s work.
  • Actively participates with investigators on inspections, conference calls, requests for information, and interactions with the FDA or outside vendors on IND Chemistry and Manufacturing Controls matters.
  • Keeps track of laboratory audits as well as GMP manufacture facilities audits conducted by the Investigational Products Core at MSKCC. Works with them in determining the facilities that should be audited and follows-up on the conclusions of the audits.
  • Participates on investigations or related efforts related to laboratory deviations, out-of-specification results, product failures or complaints, or corrective and preventive actions and other quality improvement initiatives.
  • Works with MSKCC investigators to assemble and complete the technical non-clinical and product-oriented sections of IND submission packages.
  • Writes or reviews as requested pre-clinical data reports, Investigators’ Brochure (IB), Pharmacology and Toxicology or Chemistry, Manufacturing and Control Data (CMC) sections, for submission to the IND Committee or to the FDA.
  • Through interaction with laboratory staff and investigators, and using laboratory-provided raw data or other researched sources, prepares technical reports needed for regulatory submissions.
  • Ensures that non-clinical study reports are QA reviewed prior to finalization and usage in IND application sections.
  • Collaborates with IND Office to assemble the IND application for submission to the FDA and maintains a database tracking progress and outstanding issues for all new INDs as well as submissions to FDA of IND and protocol amendments and new protocols added to existing INDs.
  • Provides information, support and guidance to PI in the course of the IND application reviews.
  • For all IND (or related product development) projects, obtains and maintains copies of all manufacturing and product testing records for review by the PI.
  • Works with PI, the Investigational Products and the Antitumor Assessment Cores to create and implement preclinical development plans, including: determining toxicology and other safety testing requirements needed, defining product characteristics and critical specifications advising as to the appropriate test methods identifying, qualifying, and contracting with manufacturing and testing providers reviewing preclinical development study protocols.
  • Maintains close relationships with MSKCC Core Facilities that cater to translational research projects. Establishes communication links among parties to the projects.
  • Attends routine and non-routine department seminars to gain knowledge of research projects that may be translated into clinical trials.
  • Works within Peds to create new research tools, the planning of symposia, and the spreading of new-found information or opportunities in the translational research sciences to provide self/staff enrichment.
  • Review agreements and payment schedules proposed by external vendors.   Provides input in regards to the statement of work, payment schedules, intellectual property, regulatory affairs, etc.
  • Works with the office of technology development, the legal department and procurement to make sure the agreements follow all internal policies and requirements.
  • Ensures that invoices billed synchronize with completed time points and communicate discrepancies with the department’s fund coordinator.  Review expenses, ensure appropriate format and provide adequate auxiliary information upon request for final approval by Manager or Administrator. Follows-up with the procurement and accounts payable department  and works with them and the fund coordinator if any issue comes up to make sure invoices are paid in a timely manner. Keeps track of all invoices received from outside vendors.
  • Participates or coordinates on both interdepartmental and intradepartmental organization-wide research projects as requested.  Provides leadership, organizational, creative, or clerical support to established and new research initiatives.

 

You have:

  • Master’s degree in biomedical sciences with 5+ years laboratory experience in a translational research setting required
  • Doctorate in science area related to medicine or medical product development with 2+ years of post degree experience preferred
  • Excellent organizational ability, attention to detail and ability to work from SOPs
  • General good communication skills for written reports and correspondence and for explaining, communicating or presenting information to department peers, management and appropriate external contacts
  • Knowledge of biomedical research and pharmaceutical terminology preferred
  • Ability to prioritize tasks based on importance and deadlines; must be self directed and independently function to ensure timely completion of major projects. She/He must have the ability to stay on schedule and independently analyze and resolve workflow disruptions. He/She must be detail oriented, organized and able to handle multiple tasks simultaneously.

 

Closing

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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