Assoc Director/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 various Neurological diseases, is actively recruiting for an exceedingly capable Project Management leader to drive the delivery of pipeline assets and technical projects.
This is an essential role in a company doing important work. Compensation will be generous.
Things to Note:
- The company is developing therapies for common debilitating diseases such as Parkinson’s as well as several rare diseases in the CNS realm. There is an intense commitment to its patients and finding solutions of impact. Seek candidates with a similar passion.
- The company is developing both AAV and Lentiviral vector therapies. Early focus will be on the Lentiviral programs, and related exposure would be valuable.
- This Director/Associate Director (client is open on level) will collaborate with the CMC team, functional leads and external partners to advance development and manufacturing from clinical to commercialization. This is an all-encompassing role that will require significant product and process knowledge.
- The company works extensively with 3rd party vendor for development and production. The right candidate will have extensive experience overseeing the work of CMOs and CDOs, and ensuring compliance with timelines, budgets and quality standards.
- This is a hands-on leadership role in an emerging business setting. Right candidate will be a collaborator who complements broad and deep scientific/technical credentials and know-how with a flexible, resourceful, mission-driven, get-it-done work style.
- This is a home-based position, with a preference for East Coast candidates (due to alignment with other colleagues as well as European partners). Regular travel to Research Triangle Park, NC may be required.
Position will involve guiding the preparation and implementation of strategic and tactical plans that support the advancement of products in alignment with the project plan, budget and milestone deliverables. This includes, but is not limited to process development, analytical development, technical transfer, cGMP and regulatory documentation and project strategy.
- Co-leads CMC team meetings alongside technical CMC Lead applying project management expertise and facilitating productive team discussions across multiple CMC programs.
- Partners with project and work stream leads to provide leadership to successfully achieve project objectives.
- Establishes, maintains and is accountable for project timelines and associated CMC plans.
- Ensures effective communication and coordination of activities and deliverables across CMC functions ensuring integration with overall program plan.
- Manages partner and CDMO relationships ensuring clear communication and accountability.
- Regularly meets with CMC management and SMEs to review recent results, set next plans, and ensure appropriate progress is being made on assigned programs.
- Proactively anticipates obstacles or risks to CMC deliverables and coordinates the development and implementation of appropriate mitigation strategies. Identifies and escalates issues as needed.
- Conducts scenario planning to proactively provide analysis and recommendations on alternative development plans, along with the associated assumptions and risks
Target candidate will offer a related technical or scientific degree as well as 7+ years of biotech/CMC project management, including 4+ years in Project Management roles. Strong preference for expertise in gene therapy but will consider those with strong CMC biologics development.
Other priorities include:
- Substantial experience overseeing/driving the work performed by external partners including ensuring their adherence to timelines, budgets and deliverables.
- Proficiency with related software tools such as: MS Project, SmartSheet, MS PPT, MS Excel, etc.
- Strong technical understanding of product development cycle as well as supply chain operations.
- Results-oriented, has a bias for action. Strong initiative, accountability and willingness to take ownership and drive projects to completion.
- Communicates clearly and precisely in both written and verbal communications including the ability to lead difficult discussions and positively influence outcomes.
- 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.