DIR, REGENERATIVE MED COMMERCIALIZATION

Director, Regenerative Medicine Commercialization

This position is 100% grant-funded.

Occupational Summary

Responsible for the coordination of the various workstreams in the program; managing the administrative and financial aspects; and building the foundation development for commercialization, building a new corporation (newco) or equivalent to translate the technology to patient care. Support of the principal investigator (PI), the manager for the scientific portion of the work, and the equity officer. Communicate between all project members, and coordinate between project workstreams and sites. This includes facilitating information and data sharing among the sites, stakeholders, and, importantly, with the funding agency.

Work Performed

* Project Monitoring and Deadline Management (10%): Oversee the progress of ongoing projects by tracking key milestones, deliverables, and timelines. Implement effective project management strategies to ensure that all tasks are completed on schedule and within scope. Identify potential risks or delays and proactively develop mitigation strategies to maintain project momentum.

* Coordination of Research and Development Activities (15%): Collaborate closely with the scientific manager to streamline the coordination of essential research activities, including data acquisition, storage, and utilization of samples and reagents. Facilitate effective communication and collaboration between multiple research groups to ensure alignment of objectives and efficient use of resources. Identify, vet, establish contracts/negotiate with CROs and CDMOs to ensure data is generating and reporting adequately to support commercial and regulatory paths

* Staff Oversight and Collaboration (10%): Supervise and support the project staff, ensuring that their roles and responsibilities are clearly defined and aligned with project goals. Foster a collaborative work environment, provide guidance and feedback, and address any performance or operational issues that arise.

* Budget Management (5%): Work in conjunction with the Principal Investigator (PI) and research administrative support to develop, monitor, and manage the project budget. Ensure financial resources are allocated appropriately, and expenditures are tracked and reported accurately. Conduct regular budget reviews and adjust financial plans as necessary to adhere to funding constraints.

* Monthly Report Preparation (10%): Compile and prepare comprehensive monthly progress reports for submission to the funding agency. Ensure reports accurately reflect project progress, financial status, and any significant developments or challenges. Maintain detailed records and documentation to support reporting requirements.

* Monthly Funding Agency Meetings (10%): Lead and facilitate monthly meetings with the funding agency to discuss project updates, address questions, and provide strategic insights. Prepare agendas, presentations, and other materials necessary for effective communication and decision-making during these meetings.

* Commercialization and Regulatory Approval (15%): Oversee the processes related to the commercialization of research outputs and ensure compliance with regulatory requirements. Coordinate

with relevant teams to navigate the regulatory landscape, manage approval processes, and facilitate the transition from research to practical application.

* Stakeholder Communication (10%): Maintain clear and effective communication with various stakeholders, including members of the equity team, commercialization team, research team, and funding agency representatives. Ensure all parties are informed of project developments, changes, and requirements, and address any concerns or inquiries in a timely manner.

* Issue Resolution (10%): Proactively identify and address issues that arise throughout the project lifecycle. Implement problem-solving strategies and collaborate with relevant stakeholders to resolve challenges and ensure project continuity.

* Additional Duties (5%): Perform other tasks and responsibilities as assigned by the Principal Investigator (PI) to support the successful execution and advancement of the project. Adapt to evolving project needs and contribute to various aspects of project management as required.

Required Qualifications

Education/Training:

Work requires a Master's degree, preferably in biological/life sciences, engineering/physical sciences, computing sciences/information technology, or business administration. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE

Experience:

• At least five years of experience in project management, particularly with complex projects involving multiple workstreams.

• Experience in managing translational science, preferably in an industrial environment
• Experience in the operational management of people (scientists, engineers, technical staff) with bench-level tactical experience
• Experience with technology transfer from an academic or government lab into a corporate environment (at least one example with involvement)
• Experience/familiarity with government-funded projects and related expectations, reporting, etc.; specific experience with ARPA, DARPA, DOD, or alternate government funding mechanisms is a plus
• Experience with collaborative projects that span multiple institutes/labs/investigators and coordination of activities, decisions, and strategy across sites and functions
• Experience successfully managing CROs and/or CDMOs in the design and performance of non-GLP and GLP preclinical studies, raw material acquisition, product manufacturing, QA/QC, and technology transfer
• Direct experience with product development, including documentation (SOPs, batch records, study designs, and reports)
• Available/able to accommodate rigorous schedule of meetings and required government reporting on a monthly cadence; monthly reporting deadlines will require work outside of core business hours, which may include some nights/weekends to manage submissions

Preferred Skills and Competencies:

• Experience in corporate/executive leadership (at Director level or above) with experience negotiating, presenting technical or business information, participating in debate and decision-making at the executive level
• Individual has written and submitted a government funding proposal (as PI or co-investigator) that was funded and managed through completion (SBIR or STTR experience especially useful)
• Direct experience in the formation of a start-up entity that ultimately received funding (beyond SBIR/STTR) and either received revenue for product sales or advanced an asset beyond Phase 1 clinical trials.
• Interests in transitioning to head of product development or operations in the NEWCO when formed and able to operate at that level