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EXEC DIR, OFC OF RESEARCH CONTRACTS
Job Title: EXEC DIR, OFC OF RESEARCH CONTRACTS
Job Code: 2962
Job Level: 19
Revised Date: 08/01/2018
Job Family: JF 28
Manages, supervises and directs, the Office of Research Contracts. ORC's responsibilities include agreements relating broadly to research funded by industry, foundations and governments, both clinical and non- clinical, scientific or medical educational programs, and exchanges of research materials and data, including PHI, with a variety of entities both commercial and non-profit. ORC reviews, negotiates, drafts and processes a wide variety of agreements relating to scientific or medical educational programs and/or the conduct of clinical and/or non-clinical research at Duke with industry, government, non-profit foundations, subcontractors, and academic entities, all in compliance with Duke University's mission, Duke policies and procedures, federal regulations and guidelines, and applicable laws, including those underlying Duke's non-profit tax status. ORC fulfills these responsibilities by applying good legal/business knowledge and judgment, expertise in contracting and academic principles, and the experience of others within ORC. The Executive Director is responsible for developing, coordinating and maintaining systems and procedures that support the efficient drafting, negotiation, processing and tracking of these varied agreements so that they are executed in a timely manner to support research in compliance with Duke standards. The Executive Director serves as Duke's senior authorized representative in negotiations of these agreements with third parties, and acts as ORC's lead representative in internal University discussions.
Produces, in collaboration with the School of Medicine senior administration, and managers, the ORC annual budget.
- Manages all aspects of the day to day operations of the ORC office.
- Manages, directs and supervises, all of ORC's research agreement operations including direct oversight of senior ORC staff.
- Manages, directs and supervises the review, drafting, negotiation, and processing of a wide variety of agreements and sub-agreements based upon Duke policies and procedures, and laws, regulations and government guidelines applicable to research.
- Maintain ORC as the recognized, knowledgeable resource for both external parties and other offices and departments within Duke for agreements relating to commercially and foundation funded research and Federal and State contracts at Duke, and the appropriate terms for agreements related to such research.
- Maintain ORC as the recognized, knowledgeable resource for transfers of research materials and data, including PHI, to and from Duke, and for the necessary agreements to establish terms for such transfers.
- Manage ORC's negotiation of agreement terms with various internal and external contacts and stakeholders, and serve as Duke's senior resource for those negotiations and other relationships associated with these agreements.
- Provides advice to Duke research teams and Principal Investigators regarding contractual requirements, liabilities, and risks.
- Establishes mechanisms for ORC to coordinate with other Duke central offices as needed to ensure that each agreement has all approvals and compliance requirements in place prior to execution.
- Consults with other offices within the Duke School of Medicine and the University, for terms and conditions that require specialized input, including Office of Counsel, Institutional Review Board, Clinical Risk Management, Office of Clinical Research, and Office of Research Administration.
- Provides approval, or disapproval, of agreements negotiated within ORC.
- Serves as institutional signatory for agreements negotiated by ORC
- Advises staff on alternative solutions to contractual issues that arise in the context of negotiations and attempts to reconcile the often-conflicting perspectives of academia and industry within established guidelines and in a manner that complements and supports Duke's overall academic mission.
- Responsible for escalation or other requests for policy waivers when agreement terms cannot be resolved in a timely manner.
- Establishes and maintains appropriate electronic system to track agreement negotiations in a timely and accurate manner. Uses ORC's tracking tools to analyze qualitative and quantitative measures for continual improvement of ORC performance; contributes to the further development and implementation of those tools and measures. Reports metrics on agreement processing where applicable.
- Leads contract management meetings contributing to the continuous improvement of ORC, its policies, processes and operations.
- Implements ORC quality control procedures to assure that all executed agreements meet organizational standards and are executed in a timely manner when meeting those standards.
The Executive Director will be a key committee member in two constituent committees which tie to important areas in School of Medicine research operations. The first is the Clinical Contracting Supply Chair committee, chaired by the Vice Dean for Clinical Research and consisting of the clinical research contracting managers in the Office of Research Contracts, leaders in the Duke Office of Clinical Research and other leaders in the Dean's Office. The second committee, chaired by Associate Dean for Research Administration, ties together the Government/Foundation Collaborations and the Basic Science and Pre Clinical Research groups to the primary central research administration areas in the School of Medicine.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Required Qualifications at this Level
Work requires an M.S. (preferably a Ph.D. or JD)
Ten years experience in drafting, reviewing and negotiating research- related agreements with a variety of entities including companies, academic centers, and government institutions, for the support of academic research, including agreements providing funding for clinical or nonclinical research, and agreements for the transfer of proprietary materials, data and information to enable such research. Five years of this experience may be replaced by three years direct scientific involvement in academic laboratory or clinical research.
Five years experience in managing and guiding team members
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
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