Reporting to the Managing Counsel for Insurance, Population Health and Regulatory Compliance, the Division Counsel, Research will provide a broad range of legal counsel to the research enterprise, with a strong emphasis on research contracts and related regulatory compliance. The Division Counsel, Research will be primarily responsible for the timely review of a wide variety of research-related contracts.
The Division Counsel, Research should be a strategic thinker, an approachable adviser, and a strong relationship builder who thrives in an intellectually challenging environment and is clearly aligned with VUMC's values.
The Division Counsel, Research provides legal analysis and advice and is responsible for handling and managing legal strategy, contract negotiations, due diligence and drafting of definitive agreements in connection with research-related activities including clinical trials, basic research, intellectual property, data and material transfers, and related regulatory review. In addition, the Division Counsel, Research will provide guidance and support for compliance with internal policies and all applicable laws and regulations related to VUMC's sponsored research agreements.
Other responsibilities will include:
* Analyze proposed research agreements, ongoing research relationships and other related research matters requiring legal or regulatory review. Will require the ability to draft, review and negotiate multiple research agreements with third parties, including clinical trial agreements, intellectual property agreements, confidentiality agreements, basic research agreements, data and material transfer agreements, federal subawards and subcontracts, and international research agreements.
* Collaborate effectively with the Office of Contract Management and the Procurement department to manage and review a high volume of research contracts and ensure a timely response and thorough review.
* Assist with the development of research contract templates that reflect VUMC's policies, needs and priorities, and appropriately balance these needs with risk management and legal exposure.
* Negotiates special transactions, including: settlement agreements, international agreements, special contracts and agreements, agreements with universities and academic medical centers, and interaction with governmental agencies.
* Ability to interact and negotiate contractual terms with government agencies, national foundations, medical device manufacturing companies, pharmaceutical manufacturing companies, bio-tech organizations, foundations and other biomedical research sponsors.
* Contribute to the development of a common language contract library reflecting VUMC's policies and standard practices.
* Engage and work effectively with outside legal counsel on an as needed basis.
* Attend regular meetings with the Office of Contracts Management and other stakeholders.
* Collaborate with counterparts at Vanderbilt University in the Office of the General Counsel and the Center for Technology Transfer and Commercialization.
Vanderbilt University Medical Center is seeking an individual with the following qualifications to make a long-term commitment to the organization.
* J.D. from an accredited law school and membership in the State Bar of Tennessee, or eligibility for admission based on reciprocity. Must obtain full licensure within one year.
* Must have seven (7) years of progressively responsible biomedical research experience gained in-house or through working closely with complex healthcare or life sciences clients. Specific experience working in an academic medical center, research foundation, medical device manufacturing or pharmaceutical company is preferred.
* Significant experience advising medical center or healthcare industry leadership on sophisticated and often highly complex research matters with minimal preparation time.
* Requires understanding of applicable laws, industry practices, and enforcement trends to identify, assess, mitigate and resolve legal risks associated with biomedical research contracts and activities.
* In-depth understanding of highly complex legal issues and ability to identify implications in specialty area.
* Excellent interpersonal communication skills, including proven ability to actively listen, negotiate, persuade and educate.
* Ability to gain trust and build credibility with a broad group of colleagues and clients, to include researchers and senior leaders.
* Stays current with regulatory critical legislative changes in area of specialty.
* Facilitate policy review and changes.
* Relied on to represent institutional concerns persuasively to internal and external parties.
* Maintains confidentiality and exercises discretion and tact when handling sensitive or potentially sensitive issues.
* Demonstrated commitment to the highest ethical standards.
Internal Number: 1911637
About Vanderbilt Health
Vanderbilt University Medical Center is home to Vanderbilt University Hospital, The Monroe Carell Jr. Children’s Hospital at Vanderbilt, the Vanderbilt Psychiatric Hospital and the Vanderbilt Stallworth Rehabilitation Hospital. These hospitals experienced more than 61,000 inpatient admissions during fiscal year 2015. Vanderbilt’s adult and pediatric clinics treated nearly 2 million patients during this same period.Vanderbilt University Hospital and the Monroe Carell Jr. Children’s Hospital at Vanderbilt are recognized again this year by U.S. News & World Report’s Best Hospitals as among the nation’s best with 18 nationally ranked specialties. Vanderbilt University Medical Center is world renowned because of the innovation, work ethic and collegiality of its employees. From our health care advances to our compassionate care, Vanderbilt owes its accomplishments and reputation to staff and faculty who bring skill and drive and innovation to the medical center day after day. World-leading academic departments and comprehensive centers of excellence pursue scientific discoveries and transformational educational and clinical advances across the entire spectrum of health and disease.As th...e largest employer in middle Tennessee, we welcome those who are interested in ongoing development in a caring, culturally sensitive and professional atmosphere. Most of us spend so much of our lives at work, we want to be part of maintaining a workplace in which people support one another and encourage reaching for excellence. Many high-achieving employees stay at Vanderbilt because of the professional growth they experience and because of their appreciation of Vanderbilt’s benefits, public events and discussions, athletic opportunities, beautiful setting and, above all, sense of community and purpose.Vanderbilt and its employees share a set of mutual expectations that have been created with productivity, legality, fairness and safety always in mind. We believe that our investment in training and compensating employees multiplies in value when we enable individuals to deliver their best performance for the benefit of us all.