Vice President, Deputy Counsel - Research

PURPOSE OF POSITION: To plan, direct and lead the Organization's legal support for research-related activities, design the interaction model and negotiation efforts with the various agencies that Cincinnati Children's partners with and/or is governed by. To serve as an organizational advisor and partner with senior leadership with respect to organization-wide research strategies. To provide and implement strategic, operational and programmatic plans and policies to achieve the mission, vision and values of Cincinnati Children's.

Representative Responsibilities

• Strategic Planning: Sets the strategic direction for the legal support for the organization's research-related activities including research misconduct investigations, NIH interactions involving legal issues, Cincinnati Children's Research Foundation (CCRF) organizational issues, legal research regulatory concerns, basic research, intellectual property, data and material transfers, and appropriate sponsored research agreements. In collaboration with Executive Leadership Team including Chief Legal Officer, and research business directors, creates short, mid, and long-term approaches to developing and enhancing the legal strategy of the research function within CCRF. Proactively identifies innovative and effective ways to deliver sound legal guidance to the organization that helps drive research innovation. Responsible for governance and authority for the regulatory environment related to new and emerging technologies throughout the organization including, Innovation Ventures and Strategy and Growth.
• Operations: - Oversees the development of operating and capital budgets for the legal support for CCRF and ensures compliance with budgetary requirements. Consults with appropriate personnel and departments to ensure that legal resources are appropriately allocated. Directs the review, modification, and approval of legal services related practices and procedures. Supervises and manages attorneys and other department professionals. Establishes performance goals and allocates resources for direct reports. Plans, leads and integrates oversight of legal strategy for research-related activities. Create and maintain processes and procedures for the legal support of CCRF. Oversees education and training for management and staff regarding legal issues and concerns related to research and healthcare. Manages utilization of external legal resources to maximize efficient, competent, quality representation while maintaining a prudent budget. Proven skills in directing and managing legal services for an institution providing legal counsel though the use of internal legal resources and external partnerships.
• Leadership: - Leadership experience in developing and motivating staff, operating in a complex organization, team building, conflict management, and negotiation. Leads, manages and guides in-house lawyers and other legal support staff with an aim towards maximizing performance and capabilities of the department. Leads continued growth and development of each team member to maximize their individual and the organization's performance. Proactively identifies unmet needs and future legal issues and proposes strategies to optimize outcomes and results. Provides vision, direction and leadership while working in a cross-functional capacity with key stakeholders in Legal, Finance, Quality, Innovation Ventures, and Operations to identify and assess organizational risks and develops risk mitigation strategies. Directs Research counsel team to ensure necessary subject matter expertise is delivered. Leads and facilitates processes for review of all research agreements. Counsels senior leaders throughout CCRF. Implements, models, champions, and maintains leader standard work expectations throughout the medical center.
• General Counsel for CCRF: - Provide legal counsel related to investigations of any matters brought forward by regulatory authorities relating to research activities, including audits and investigations commenced by (i) the federal Office of Human Research Protections; (ii) the federal Office for Laboratory Animal Welfare; (iii) the federal Office for Research Integrity; and (iv) any other government or agency. Analyzes proposed research agreements, ongoing research relationships and other related research matters requiring legal or regulatory review. Negotiates special transactions, including settlement agreements, international agreements, special contracts and agreements, agreements with universities and academic medical centers, and interaction with governmental agencies. Manage and facilitate processes for review of major research agreements, using in-house legal staff and outside legal counsel.
• Regulatory Compliance: - Provides counsel and advice on research compliance and informed guidance on lab safety requirements. Embraces change management through the exploration, development and implementation of evidence-based practice and quality efforts. Identifies best practices as well as deficiencies to share with peers and facilitate improvements. Ensures regulatory compliance following appropriate guidelines to mitigate potential research-related risks. Develops and oversees implementation and compliance of internal policies and procedures in conjunction with Regulatory Affairs and Legal Services. Maintains compliance with all regulatory bodies including NIH and other government agencies.

Qualifications:

Education/Experience

Required:

• Juris Doctor

• 15 years healthcare law and relevant practice experience

• Maintain licensure to practice law in the State of Ohio

Education/Experience

Preferred:

• 5 years biomedical research experience gained in-house or through working closely with complex healthcare or life sciences clients.

• Large law firm experience

• Specific experience working in an academic medical center, research foundation, medical device manufacturing or pharmaceutical company.

Unique Skills

• Communication - Excellent verbal, written and interpersonal communications skills as well as excellent presentation skills to a variety of audiences.

• Relationship - Knowledge of related outside regulating agencies, roles, and responsibilities. Build strong internal and external relationships.

• Negotiation - Influences and effectively works with others to reach desired outcomes. Experience in building and managing strong external and internal partnerships to mitigate potential research-related risks.

• Judgment - Use knowledge and experience to make judgments and recommendations regarding operations and budgets, protocols and generate well-developed solutions.

• Leadership - Experience in a leadership role in an academic medical center, research foundation, medical device manufacturing or pharmaceutical company.

• Information - Analysis Locating and gathering relevant information; recognizing and working to eliminate important gaps in existing information; determining the value of the information; synthesizing and organizing information to get a better understanding of a problem to develop appropriate actions.

• Execution - Efficiently delegating work that is the appropriate level of difficulty and giving others the authority to accomplish it; providing information, coordinating work efforts, providing assistance, and removing obstacles without becoming overly involved in daily or minor issues; following through and monitoring progress to ensure goals are achieved.

• Problem Solving - Ability to collect and analyze data to identify opportunities, gaps and to make strategic recommendations that resolve problems.

Cincinnati Children's is proud to be an Equal Opportunity Employer that values and treasures Diversity, Equity, and Inclusion. We are committed to creating an environment of dignity and respect for all our employees, patients, and families. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, national origin, sexual orientation, gender identity, disability or protected veteran status. EEO/AA/M/F/Veteran/Disability