Global Director/Senior Director, Project Management (CMC/Gene Therapy) – Remote/Top $
Our client, a North Carolina biotech that boasts a growing portfolio of cutting-edge gene therapies to treat Neurological diseases, is actively recruiting for an exceedingly capable candidate to drive the delivery of pipeline assets.
This is a high profile, high impact role. We seek a Project Management leader with an impressive track record of moving programs forward by effectively directing the work of internal and external cross-functional teams. Compensation will be generous.
Key Things to Note:
- The company is developing Adeno-associated virus and Lentiviral vector therapies to treat common CNS diseases such as Parkinson’s as well as several rare diseases in the CNS realm. There is an intense commitment to patients and finding solutions of impact.
- This Director/Senior Director (client is open to both levels) will collaborate with the CMC team, functional leads and external partners around the globe to advance development and manufacturing from clinical to commercialization. Gene therapy bkgd is preferred. Cell therapy bkgd is also of interest. Global exposure will be critical.
- The company relies heavily on 3rd party vendors and partners for development and production. Right candidate will have extensive experience overseeing the work of CMOs and CDOs, and ensuring compliance with timelines, budgets and quality standards.
- This Director/Senior Director will be the voice and face of the company to many constituents including executive leadership, other department heads, regulatory authorities, etc. Seek candidate whose technical knowledge and know-how are complemented by superb presentation skills.
- This is a hands-on leadership role in an emerging business setting. Policies, practices and priorities are constantly changing. Seek candidate who brings the flexibility, resourcefulness and mission-driven work style needed to thrive without a roadmap.
- This is a home-based position, with a preference for East Coast candidates (due to alignment with colleagues as well as European partners). Regular travel to Research Triangle Park, NC may be required.
Selected Responsibilities and Duties:
- Strategic and tactical partner to the project team leader and line function representatives accountable to establish and deliver aligned cross-functional plans across all relevant development functional groups into a cohesive development plan.
- Drive development process planning activities of the project teams including milestone setting, strategic integrated development plans, long range plans, budget input and go/no go criteria.
- Drive the cross-functional team to deliver to agreed-upon goals.
- Maintain all project management tools. Facilitate team meetings/agendas/minutes/action items.
- Coordinate team goal setting and tracking to ensure adherence to plan and agreed-upon milestones.
- Liaise with partners, CMOs, etc. ensuring contractual obligations are met, and a healthy relationship is maintained. Participate in diligence in securing new relationships with partner as needed.
- Ensure effective communication and coordination of activities and deliverables across all functions ensuring integration with overall program plan.
- Conduct scenario planning to proactively provide analysis and recommendations on alternative development plans, along with the associated assumptions and risks.
- Partner with the VP, Project Management and other functional leaders to assess project management processes to ensure best practices are employed for the needs of the company
Target candidate will offer a related technical or scientific degree as well as 10+ years of biotech/drug development, including 5+ years in Global Project Management roles. Strong preference for expertise in gene therapy but will consider those with strong CMC biologics development.
Beyond that, we seek an impactful leader with a history of delivering results in a dynamic, high expectations, complex environment.
Other priorities include:
- Demonstrated ability to provide project management leadership for the lifecycle of a program from discovery through launch
- Proven track record of planning and managing complex programs in different phases of development including cross functional deliverables (Research, CMC and Commercial)
- Substantial experience overseeing/driving the work performed by external partners including ensuring their adherence to timelines, budgets and deliverables.
- Results-orientation, including a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Clear, precise, tactful, persuasive and proactive communicate skills including the ability to lead difficult discussions and positively influence outcomes.
- Proficiency with related software tools such as: MS Project, SmartSheet, MS PPT, MS Excel, etc.
- Experience in and affinity for emerging, clinical phase companies that operate in a collaborative, empowered, dynamic, hands-on and mission-driven manner.
- Record of impact, achievement and longevity
This is an immediate need. Any package will include a generous base, bonus, equity and benefits.
Please forward Word resume for prompt consideration.