Experience

New York Medicine Jobs

• Higher Education
• 100 - 200 Employee

• Contracts Manager

  • Dec 2016 - Present

  • As an integral part of the managerial team of the Office of Clinical Research (OCR) at MSKCC, provide managerial oversight to regulatory analysts responsible for negotiating legal and contractual documents associated with prospective clinical research performed at the institution.• Negotiate directly with external entities (sponsors, supporters, academic institutions) for prospective clinical research performed or supported by MSKCC• Establish and maintain processes that streamline the negotiation process.• Liaise with members of MSKCC clinical research community (investigators, research managers, research assistants) to facilitate negotiations.• Serve as direct liaison to MSKCC Office of General Counsel to ensure complete compliance to clinical research related regulation, law and policy.• Develop and maintain resources utilized in the negotiation process (contract templates, fallback language, policy documents).

• Contracts Manager

  • Dec 2016 - Present

  • Provide legal review, advise and negotiate agreements involving intellectual property and research at the Medical Center including, research, license, material transfer (incoming and outgoing), confidentiality, peer institutional, consulting, software agreements, and other agreements • Act as principal liaison on agreement review, negotiation and processing between: Sponsored Programs Administration (SPA) and sponsoring agencies; NYU’s Perlmutter Cancer Center; collaborating institutions; NYU’s Principal Investigators; NYU’s Office of Science and Research (OSR), NYU’s Office of Intellectual Liaison (OIL), NYU’s Office of Clinical Trials (OCT), NYU’s Development office, NYU’s Office of Legal Counsel (OLC); NYU’s Insurance department; NYU’s Research Finance department, and other departments or offices and individuals involved in SPA’s contract reviews and negotiations, all in accordance with SPA’s guidelines and instructions• Oversee staff assignments and evaluate job performance of Contracts Specialist and Analysts.• Coordinate with involved faculty to ensure agreements meet faculty needs. • Keeps faculty apprised of negotiation process/• Ensure agreements comply with NYU policies and procedures, and regional and federal regulations.• Monitor progression of negotiations to ensure timely completion, and informs relevant individuals of delays to determine if they can be overcome, consistent with institutional policy.• Cultivate strong working relationship with other parties in negotiations, promote productive business relationships.• Seek and implement creative solutions to obstacles encountered in negotiations, to meet both parties’ needs. • Train Perlmutter Cancer Center personnel about institutional practices and policies and in use of central administration systems.• Provide guidance regarding Perlmutter Cancer Center non-industry sponsored programs.



Memorial Sloan Kettering Cancer Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Contracts Manager

  • Oct 2012 - Nov 2016

  • As an integral part of the managerial team of the Office of Clinical Research (OCR) at MSKCC, provided managerial oversight to regulatory analysts responsible for negotiating legal and contractual documents associated with prospective clinical research performed at the institution. • Negotiated directly with external entities (sponsors, supporters, academic institutions) for prospective clinical research performed or supported by MSKCC. • Established and maintained processes that streamline the negotiation process. • Liaised with members of MSKCC clinical research community (investigators, research managers, research assistants) to facilitate negotiations. • Served as direct liaison to MSKCC Office of General Counsel to complete compliance to clinical research related regulation, law and policy. • Developed and maintained resources utilized in the negotiation process (contract templates, fallback language, policy documents).



Janssen Research and Development, LLC(Pharmaceutical Companies of Johnson&Johnson)

• Titusville, New Jersey

• Contract Specialist

  • Nov 2011 - Oct 2012

  • Expedite contract negotiation and execution by acting as legal resource for the Contracts and Grants group to streamline requests to law department and avoid duplication of efforts among Contract & Grants Analysts. • Serve as a main point of contact with legal department to resolve complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to Contracts and Grants team members. • Analyze, manage and expedite resolution of complex legal issues in the clinical trial contracting process. • Serve as subject matter expert for healthcare compliance issues in clinical trial contracting. • Coordinate and assist in drafting and implementation of intra-company agreements and other relevant legal documents to ensure compliance with corporate process, system and strategies. • Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed. • Lead/conduct contract negotiations on terms and conditions of high-risk and complex agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies. • Responsible for assessing risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. • Provide advice to Contract and Grants Analysts, stakeholders and others within Janssen on contracts and grants. • Develop and maintain contract templates in accordance with changes in laws, regulations, or corporate policies. • Adhere to SOPs, ethics and departmental compliance as determined by management as well as R&D companies, corporate, HCC and QA guidelines.



ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company

• Biotechnology Research
• 200 - 300 Employee

• Clinical Contract Specialist

  • Jun 2009 - Dec 2011

  •Negotiated and finalized: master service agreements, clinical service agreements, outsourcing and vendor agreements, confidentiality agreements, letters of indemnification, letters of delegation, informed consents, and other documents associated with the performance of trials sponsored by ImClone •Reviewed and revised regulatory documents. Among them – informed consents, case report forms, and investigator disclosure forms. •Established and maintained direct negotiations with academic centers, network centers, and other entities that perform clinical trials sponsored by ImClone (all phases – US & Ex-US – Africa, Asia, Europe, Middle East, and South America). •Liaised with other members of ImClone’s Global Clinical Operations group (Project Managers, Clinical Trial Managers, Clinical Research Associates, etc) to ensure timely site initiations and monitoring. •Compliance Responsibilities: Undertook and completed anti-corruption due diligence efforts to ensure investigator and site compliance to the Foreign Corrupt Practices Act (FCPA). •Global Project Management: global contract negotiations, clinical research organization educational and managerial responsibilities.



Benjamin and Associates

• Consultant / Freelancer

  • Jan 2009 - May 2009



New York Presbyterian Hospital (Clinical Trials Office)

• Director of Contracts

  • Oct 2005 - Dec 2008

  Identified long term research and clinical trial opportunities and partnerships for CUMC.Supervised the negotiations of multiple master service contracts and clinical trial agreements, including early clinical development initiatives with major pharmaceutical corporations.Initiated and finalized practices and policies that enhanced standing in the research community.Maintained management of the contracts department that is annually responsible for negotiating two hundred clinical trial agreements for all testing phases and therapeutic areas.Provided assistance in the development of policies that improved regulatory compliance in the performance of clinical trials at CUMC.Advice and counsel provided to CUMC’s research community for clinical trials opportunities under negotiation.Developed template agreements and contractual language used in negotiations with pharmaceutical corporations.Represented CUMC at numerous in-house and outside conferences and seminars.

• Manager of Contracts

  • Jun 2003 - Oct 2005

  Trained, managed and supervised members of the contracts department whose members are responsible for negotiating and finalizing clinical study agreements and other related regulatory documents that govern clinical trials performed at the medical center. These agreements, collectively, have a potential value in excess of $10,000,000 (US).Devised and implemented policies and procedures that have streamlined the contracting process and increased the number of agreements finalized.Interfaced with members of office management, medical center physicians, attorneys of the office of general counsel and representatives of the pharmaceutical industry to facilitate and increase awareness of the contracting process.Reviewed and negotiated high priority clinical study agreements.Drafted a variety of agreements which are used internally and externally.Prepared monthly reports that track the execution of clinical study agreements.

• Project Officer / Senior Project Officer

  • Oct 2001 - Jun 2003

  Negotiated and finalized clinical study agreements, confidentiality agreements, master service agreements, work orders, and contract amendments on behalf of medical center with well known pharmaceutical companies (Phases I-IV, all therapeutic areas).Reviewed and revised regulatory and clinical study related documents. Among them - contracts, informed consents, case report forms, 1572 investigator forms, and budgets. Established and maintained communication with corporate representatives, members of the medical staff (including physicians, investigators and coordinators), and general counsel.Developed and implemented strategic plans and procedures to improve contract negotiation process.