Sr. Director, Ops Program Management & Strategy
Humacyte
Durham, NC
DEPARTMENT: Administrative LOCATION: Durham, NC; Partially Remote COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit . JOB SUMMARY: The (Sr.) Director, Operations Program Management & Strategy is responsible for managing and/or providing oversight for the development and implementation process of Humacyte’s programs, products and activities through coordination of cross departmental or cross functional teams. The individual in this role will lead project manager(s) and monitor project teams from initiation through delivery to include planning, scheduling of activities and work streams and monitoring budgets/spend of projects for projects ranging from R&D through commercialization. This position will be a key player in the development and delivery of the site strategic plan. Both the (Sr) Director, Operations Program Management and Strategy and their team of Project Managers are to partner with the functional areas for the projects they are managing to include creation and/or execution of necessary documentation, providing key information through research, identifying and working to remove barriers to successful and timely completion of programs/projects. ESSENTIAL FUNCTIONS:
- Provide management and advancement of the site strategic plan at Humacyte. The site strategic plan incorporates the network strategy, digital strategy, operating model, and people strategy across all the operations departments/groups.
- Lead the development and delivery of overlapping late-stage, early-stage, and commercial programs
- Demonstrates a strong understanding of corporate objectives and required programs to ensure delivery on corporate objectives through cross-functional program management
- Provides strategic leadership for a portfolio of programs and projects
- Lead the timely review and governance of programs with key stakeholders at critical milestones
- Report detailed status updates to leadership and executive team
- Work with leadership to set strategic plan, goals and objectives for programs
- Support senior leadership in determining budget / resource requirements and partner with finance as needed to ensure efficient budget review cycle
- Monitor and report on program/projects progress, providing regular updates to key stakeholders and addressing any deviations from the plan.
- Deliver regular, robust and accurate updates to the leadership team on program progress with highlighted risks and proposals for mitigating risks
- Develop and ensure the maintenance of program risk management methodologies and escalate enterprise-level risks to senior leadership as required
- Apply change, risk, and resource management principles when needed
- Resolve problems between program teams and other internal stakeholders
- Create detailed implementation plans to include deadlines, milestones, processes, resource allocation, budget projections and risk mitigation protocols
- Provide processes for monitoring performance and collaborating with program teams to determine ways to improve
- Provide thoughtful analysis of critical project/program elements and develop strategic project/program plans to ensure plan development includes capacity planning, budget analysis, gap assessments
- Partners with internal stake holders to execute on administrative elements necessary for project completion
- Influence and negotiate with department heads and stakeholders to gain alignment within the team, support conflict resolution and remove barriers to success
- Ensure the maintenance of a broad overview of program status with respect to development history, risks and issues, and strategic cross-functional activities to ensure visibility of key scientific, technical, and operational work streams at the senior leadership level
- Ensure the PM team is proactively managing key actions and deliverables through to effective resolution while maintaining relationships
- Develops project and program management tools and techniques to facilitate knowledge management and communication across the organization
- Ensure traceability of key knowledge management documents and information to support regulatory filings and other critical processes
- Exercises sound judgement in determining appropriate project communications to internal and external stakeholders
- Manages the program management team to meet company goals, timelines, and deliverables
- Other duties, as assigned
- BA/BS required. Focus in science and/or graduate level degree preferred
- Minimum of 10 years of pharmaceutical and/or biotech experience with minimum of 6+ years of cross-functional project management experience in scientific and/or technical environments
- PMP or similar certification/training required
- Must have past team management experience
- Extensive experience in project management tools & techniques, such as Gantt charts, Governance plans, risk registery, cost accounting, Critical Path Analysis, Cost-Benefit Analysis is required.
- Demonstrated experience in program management and corporate or site strategic planning is required.
- Working knowledge of pharmaceutical and/or biotech regulatory process is required. Experience with Biologics IND or BLA filings and commercial manufacturing is strongly preferred.
- Excellent communication and interpersonal skills.
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
- Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
- Excellent organizational and time management skills with ability to set own priorities in a timely manner.
- Represents the organization in a positive and highly professional manner.
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
Posted 2025-08-30
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