General Manager, FDA Regulatory Affairs and Medical Product Development, and Start Up Company and Alliance Development, Brock Family Center for Applied Innovation (BFCAI)

Discover Vanderbilt University Medical Center: Located in Nashville Tennessee and operating at a global crossroads of teaching discovery and patient care VUMC is a community ofindividuals who come to work each day with the simple aim of changing the world. It is a place where your expertise will be valued your knowledge expanded and your abilities challenged. Vanderbilt Health is committed to an environment where everyone has the chance to thrive and where your uniquenessis sought and celebrated. It is a place where employees know they are part of something that is bigger than themselves take exceptional pride in their work and never settle for what was good enough yesterday. Vanderbilts mission is to advance health and wellness through preeminent programs in patient care education and research.

Organization:

Office of Research

Job Summary:

JOB SUMMARY
The General Manager for FDA Regulatory Affairs Medical Product Development and Start Up Company and Alliance Development in the Brock Family Center for Applied Innovation (BFCAI) will play a pivotal role in advancing innovation and enhancing the reputation of the Vanderbilt University Medical Center BFCAI through knowledge and application of FDA regulatory affairs and the development and implementation of strategies to advance and increase the value of new medical addition the General Manager will work as an integral part of the BFCAI team to advance internal start-up companies and support the development of corporate alliances. This includes start-up companies and alliances for both life sciences and digital health. The position reports to the Director for the BFCAI. All functions will also frequently involve work in collaboration with the Center for Technology Transfer and Commercialization (CTTC). FDA regulatory affairs work will include support for the IRB on a regular basis for FDA regulatory analysis and recommendations for novel medical device protocols.

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KEY RESPONSIBILITIES

Advises develops and leads implementation of strategies for investigators and the institution about FDA regulatory affairs and medical product development

Monitors and analyzes new legislation federal regulations guidance documents standards and program initiatives; responsible for identifying interpreting and applying relevant documentation. Serves as a central resource for the Vanderbilt research community to provide expertise and FDA regulatory and medical product development guidance to facilitate research and commercialization. Demonstrates the ability to understand the science of medical product research and development to actively support institutional activities for FDA-regulated product research. Establishes and maintains communications with investigators and research staff conducting FDA-regulated research authors and disseminates materials as necessary and provides training for research personnel as needed. Assists and supports investigators in determining appropriate internal documentation for institutional review board (IRB) human research protection program (HRPP) submission and external documentation (premarket regulatory requirements including pre-submission documents and request for risk determinations) for FDA submissions. Submit pre-IDE IDE and risk determination applications to FDA as needed Supports the IRB HRPP and provides written analysis of the risk determination for medical devices and other medical products under review. Assists and supports researchers in the development and management of standard operating procedures and other documentation according to applicable regulations. Actively participates in or leads individual/or institutional FDA regulatory affairs and medical product development projects related to the Brock Center and CTTC. Collaborates with customers across Vanderbilt to develop departmental team and individual goals through ongoing training and supplemental support. Participates in development of value in Brock Center and CTTC start-up companies in formation through FDA regulatory strategy and medical product development implementation

Plans advises and leads the development of select Start-up Companies and Strategic Alliances for Research and Development in cooperation with the Director of the BFCAI:

1. Start Up Companies: plan advise and lead on medical product development in cooperation with start-up company teams particularly for medical products that require FDA regulatory clearance. Strategic Alliance Development: Identify initiate and sustain strategic alliances with life sciences and digital health companies to advance the medical centers research and development reputation in cooperation with the BFCAI and Vanderbilt Medical Center Development.

2. Relationship Management: Cultivate and maintain strong relationships with key stakeholders from the VUMC faculty and in life sciences companies and external strategic partners including senior executives researchers and decision-makers. Si

3. Knowledge and Assessment of VUMC Capabilities: Through meetings with faculty and attendance at internal seminars and conferences develop a very thorough almost encyclopedic knowledge and assessment of internal VUMC research and development capabilities. Particularly those relevant to potential FDA regulated medical products that could be developed as a start up company or through an alliance.

4. Proposal Development and Matching: Develop proposals with VUMC faculty for presentation to potential product development consultants and partners or corporate alliance partners. Match start-up company medical products and corporate research and development alliance interests with VUMC capabilities and preset them well both verbally and in writing. Proposal development will include related budgets with scope of work.

5. External Partners for Start Up Companies and Alliances: Develop knowledge and relationships of medical product development partners CROs and other external services that may be needed to complete a start-up company or corporate alliance transaction.

6. Communication: Serve as the primary liaison between the Brock Center and external partners. Facilitate effective communication ensuring that both parties are informed aligned and engaged in collaborative projects.

7. Project Execution and Coordination: Collaborate with internal teams to negotiate and execute statements of work (SOWs) and contracts for collaborative projects ensuring that all terms and conditions are met. Manage coordination of projects after execution for goals timelines and budget. Give advice on approaches to VUMC participants and corporate alliance partners as challenging issues arise during research and development activities.

8. Resource Allocation: Work with the Director of the Brock Center and the Chief Scientific and Strategy Officer (CSSO) to allocate resources and prioritize projects that align with the Medical Centers strategic goals and objectives.

9. Strategic Planning: Contribute to developing long-term strategic plans for partnerships with venture studios product development consultants and partners and life sciences and digital health companies to drive both start-up company and research innovation and growth.

10. Performance Metrics: Define and track key performance indicators (KPIs) to measure the success and impact of collaborative projects ensuring that they align with the BFCAI and medical centers goals.

11. Compliance: Ensure all collaborative projects adhere to legal and regulatory requirements including intellectual property rights data sharing PHI and ethical standards. Work effectively with VUMC research legal intellectual property and compliance groups.

12. Budget Management: Collaborate with the BFCAI Director and CSSO to effectively manage the budget allocated for external relations and collaborative projects.

13. Reporting: Provide regular updates and reports on the progress of start-up company projects partnership development and external relations activities to the leadership team.

14. Integration: Work closely and effectively with the Office of Research which provides administrative and financial management support for the BFCAI.

Qualifications:

- Advanced degree in a relevant field (e.g. life sciences business law healthcare management)

- Proven experience in managing FDA regulatory affairs medical product development and industry collaborations is strongly preferred

- Strong communication negotiation and interpersonal skills.

- Excellent project management and organizational abilities.

- Strategic thinking and the ability to align partnerships with BFCAI and VUMCs goals.

- Knowledge of legal and regulatory requirements related to collaborative projects.

- Ability to work collaboratively within a cross-functional team.

- Reporting and budget management experience is a plus.

This role offers a unique opportunity to make a significant impact on the medical centers research commercialization endeavors and reputation through knowledge of FDA regulatory affairs medical product development start-up company development strategic life sciences and digital health corporate alliances.

Our professional administrative functions include critical supporting roles in information technology and informatics finance administration legal and community affairs human resources communications and marketing development facilities and many more.

At our growing health system we support each other and encourage excellence among all who are part of our workforce. High-achieving employees stay at Vanderbilt Health for professional growth appreciation of benefits and a sense of community and purpose.

Core Accountabilities:

* Organizational Impact: Directs activities to achieve operational plans with some near term effect on results of the department/area.* Problem Solving/ Complexity of work: Identifies issues gathers facts to resolve technical and operational problems. * Breadth of Knowledge: Applies in-depth knowledge and skills of a professional/technical area and basic management knowledge to manage the work of the team.* Team Interaction: Leads a complex department with a focus on implementation. Typically executes on a short to medium term strategies.

Core Capabilities :

Supporting Colleagues: - Develops Self and Others: Invests time energy and enthusiasm in developing self/others to help improve performance e and gain knowledge in new areas. - Builds and Maintains Relationships: Maintains regular contact with key colleagues and stakeholders using formal and informal opportunities to expand and strengthen relationships. - Communicates Effectively: Recognizes group interactions and modifies ones own communication style to suit different situations and audiences .Delivering Excellent Services : - Serves Others with Compassion: Seeks to understand current and future needs of relevant stakeholders and customizes services to better address them. - Solves Complex Problems: Approaches problems from different angles; Identifies new possibilities to interpret opportunities and develop concrete solutions. - Offers Meaningful Advice and Support: Provides ongoing support and coaching in a constructive manner to increase employees effectiveness. Ensuring High Quality - Performs Excellent Work: Engages regularly in formal and informal dialogue about quality; directly addresses quality issues promptly. - Ensures Continuous Improvement: Applies various learning experiences by looking beyond symptoms to uncover underlying causes of problems and identifies ways to resolve them. - Fulfills Safety and Regulatory Requirements: Understands all aspects of providing a safe environment and performs routine safety checks to prevent safety hazards from occurring. Managing Resources Effectively: - Demonstrates Accountability: Demonstrates a sense of ownership focusing on and driving critical issues to closure.- Stewards Organizational Resources: Applies understanding of the departmental work to effectively manage resources for a department/area. - Makes Data Driven Decisions: Demonstrates strong understanding of the information or data to identify and elevate opportunities. Fostering Innovation: - Generates New Ideas: Proactively identifies new ideas/opportunities from multiple sources or methods to improve processes beyond conventional approaches. - Applies Technology: Demonstrates an enthusiasm for learning new technologies tools and procedures to address short-term challenges. - Adapts to Change: Views difficult situations and/or problems as opportunities for improvement; actively embraces change instead of emphasizing negative elements.

Position Qualifications:

Responsibilities:

Certifications:

Work Experience:

Relevant Work Experience

Experience Level:

3 years

Education:

Bachelors

Vanderbilt Health is committed tofosteringan environment where everyone has the chance to thrive and is committed to the principles of equal opportunity. EOE/Vets/Disabled.