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DIR, REGENERATIVE MED COMMERCIALIZATION
Job Title: DIR, REGENERATIVE MED COMMERCIALIZATION
Job Code: 1010
FLSA: E
Job Level: 98
Revised Date: 11/01/2024
Job Family: JF 28
Occupational Summary
This position is responsible for managing a federally funded, multi- center regenerative medicine program. This position will oversee diverse workstreams, including research, technical, commercialization, and equity initiatives while supporting the transition of research from bench to bedside. The role includes working with others on the team and an advisory board in the development of an appropriate commercialization strategies, potentially forming a new corporation (newco) or equivalent. Coordination with the Office for Translation & Commercialization will be required. The position will also manage regulatory approval processes with consultants and guide the overall product commercialization pathway. This role will also serve as the primary liaison between the project team, stakeholders, and the funding agency and support the program's administrative, financial, and operational activities. This role offers the opportunity to work at the intersection of research and industry, driving meaningful impact through the commercialization of cutting-edge university technology.
Work Performed
Workstream Coordination:
Coordinate efforts across diverse workstreams, including research, technical, commercialization, and equity-related activities.
Facilitate communication and information sharing between project sites, key stakeholders, and the funding agency, ensuring alignment and transparency.
Work closely with the Principal Investigator (PI), scientific manager, and equity officer to ensure that project goals are met and timelines are adhered to across all workstreams.
Project Monitoring & Deadline Management:
Track critical milestones, deliverables, and timelines to monitor project progress.
Identify risks and develop and implement mitigation strategies to ensure projects remain on track and within scope.
Maintain an updated project dashboard to facilitate real-time status updates for stakeholders and the funding agency.
Budget Management:
Collaborate with the PI and financial support team to develop, monitor, and manage project budgets, ensuring accurate forecasting and financial oversight.
Ensure full compliance with grant funding requirements and provide comprehensive financial statements and reports to the funding agency as needed.
Commercialization & New Corporation Development:
Lead commercialization efforts, including market analysis, regulatory approval strategies, and product launch plans for research outputs transitioning to practical application.
Collaborate with the others on the team, the Office for Translation and Commercialization, and with advice form an advisory board to determine the most appropriate commercialization strategy, including market analyses, IP protection, pitch deck development and assistance with creating a new corporation (newco) to bring the technology to market.
Oversee the regulatory pathway, guiding the research team through pre clinical, clinical, and regulatory approval phases for the developed technologies.
Facilitate the transition from research to commercial application, ensuring alignment with industry standards and regulatory frameworks.
Research Activity Coordination:
Support the scientific manager in coordinating research activities, such as data acquisition, sample management, and protocol adherence.
Ensure effective communication and collaboration between research groups, optimizing resource use and maintaining project focus.
Staff Oversight & Collaboration:
Supervise and guide project staff, clearly defining roles and responsibilities and ensuring that tasks are completed in alignment with project goals.
Promote a collaborative work environment and address any performance or operational issues to maintain team efficiency.
Monthly Report Preparation & Meetings:
Compile comprehensive monthly progress reports for the funding agency, detailing the status of each workstream, financial expenditures, and any identified risks or issues.
Lead monthly meetings with the funding agency and other key stakeholders to provide project updates, address questions, and resolve challenges.
Stakeholder Communication & Issue Resolution:
Maintain proactive and transparent communication with stakeholders, including research teams, commercialization experts, equity officers, and funding agencies.
Identify and resolve project related issues promptly to prevent delays or setbacks.
Additional Duties: Perform other duties as required by the PI to ensure the successful advancement of the project.
Adapt to evolving project needs and contribute to various aspects of project management, particularly in areas involving commercialization and regulatory affairs.
Required Qualifications at this Level
Education/Training
Work requires a Master's degree preferably in biological/life sciences, engineering/physical sciences, computing sciences/information technology or business administration.
Project Management Professional (PMP) certification or equivalent is considered an asset.
Experience
At least five years of experience in project management, particularly with complex projects involving multiple workstreams.
Experience in managing administrative and financial operations within healthcare industry or medical research organizations is highly desirable.
Experience in product commercialization, particularly with regulated medical products, is essential. This includes guiding projects through market analysis, regulatory approval, and product launch strategies.
Experience in regenerative medicine, clinical research, or business development, with direct industry experience in medical product development, is strongly preferred.
OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE
Skills
Knowledge of and/or experience in a hard science (highly preferred); excellent interpersonal skills; written and verbal communication skills; ability to interact effectively in both academic and corporate cultures; ability to interact with scientists, research sponsors, industry representatives and patent attorneys; ability to work independently as well as in a team environment; to work under pressure with tight deadlines; business experience in negotiations, contracts, and new technology commercialization; highly self-motivated professional with exceptional sales, marketing and negotiating skills; experience in evaluating the commercial potential of early stage technology, and to effectively communicate the commercialization vision; detail oriented with ability to work on multiple projects at the same time; knowledge of intellectual property law and licensing practices; high degree of energy and enthusiasm.
Project Management: Strong expertise in planning, executing, and monitoring projects from initiation to completion.
Communication: Exceptional written and verbal communication skills, with the ability to present complex information clearly to both scientific and non-scientific audiences.
Financial Acumen: Experience with budgeting, financial planning, and resource allocation, particularly for grant-funded projects, ensuring financial compliance and accurate reporting.
Team Leadership: Proven ability to lead, mentor, and collaborate with multidisciplinary teams, providing effective guidance, feedback, and performance management.
Commercialization & Regulatory Expertise: Direct experience in navigating the commercialization pathway, including securing regulatory approval for new medical products or technologies.
Organizational Skills: Strong ability to prioritize and manage multiple responsibilities concurrently, ensuring that project objectives are achieved on time and within scope.
Adaptability: Ability to pivot and manage changes in project scope, particularly in fast-moving, innovative fields like regenerative medicine and medical product development.
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.
Duke University is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy related conditions), sexual orientation, or military status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
