Associate Director, CMC Strategy and Program Management
Assoc. Director, CMC Strategy and Program ManagementAllakos Inc. is a clinical-stage company developing therapeutic antibodies for inhibitory receptors on the surface of immune effector cells involved in allergic, inflammatory and proliferative diseases. Allakos is committed to developing innovative therapies that transform patients’ lives. We are looking for bright and talented individuals to join our team and share in our passion and commitment to improving the lives of patients.
Position Summary:The Associate Director of CMC Strategy and Program Management will serve a key role in establishing business processes and supporting the team during the preparations. The initial focus will be on launch of lirentelimab but the Associate Director will also have responsibility to support additional CMC projects and initiatives as they arise. The Assoc Director of CMC Strategy and Program Management reports directly to the Head of CMC Strategy and Program Mgmt supporting strategic planning and execution of near and long term corporate goals. The incumbent will play a key role in integrating work across complicated projects with aggressive timelines. This role will require a candidate who is comfortable working collaboratively with technical teams who also enjoys providing hands- on program management support for successful execution of project plans.
- Work closely with the Head of CMC Strategy and PM to capture and establish CMC product development strategy, business operations and product lifecycle management
- Execute on "right -size" and scalable business processes established for Technical Operations
- Serve as PM for new IND program. Partner with the CMC Team Lead in managing the internal and external team activities. Manage the integrated strategic and tactical plans and routinely track performance relative to project plan.
- Serve as the major communication link to Finance organization for budget and quarterly / year- end closes
- Focus on continuous improvement and operational effectiveness by proactively identifying issues and implement appropriate and timely mitigation plans
- Prepare Tech Ops monthly reports
- Prepare presentations for the Head of Tech Ops for various forums
What we Value:
- At least 8 years of experience in a drug development environment
- At least 5 years of experience in Project Management (PMP certification a major advantage)
- Proven track record in CMC leadership and business operations
- Demonstrated ability to influence Technical Operations leadership on complex business topics
- Demonstrated understanding of the elements required for successful regulatory CMC submissions
- Excellent communication, time and project management skills and ability to champion the CMC strategy