What are the responsibilities and job description for the Director / Sr. Director, CMC Project Management position at Alkeus Pharmaceuticals Inc?
Alkeus Pharmaceuticals, Inc. is a clinical-stage biotech company focused on the development of innovative therapies to treat serious diseases of the eye with high unmet need. Based in Cambridge, Mass., Alkeus was founded in 2010, and since that time has been developing its lead compound, gildeuretinol acetate (ALK-001). Designated as a breakthrough therapy and granted orphan drug status by the U.S. Food and Drug Administration, gildeuretinol is being evaluated in multiple clinical trials for the treatment of Stargardt disease and geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness in the U.S.
Position Summary :
Reporting to the VP of CMC & Technical Operations, the Director / Sr. Director, CMC Project Management will have proven experience in project management related to all phases of development. As a key member of designated program teams, the CMC Project Manager will work collaboratively with cross-functional team leaders and the program team to drive the definition of our CMC strategy and provide team support through validation, commercial launch and post launch activities.
Primary Responsibilities :
- Manage the deliverables, scope, timelines, resources on CMC project activities for ALK-001. Identify and analyze project risks and help guide team to develop appropriate mitigation strategies
- Lead the translation of strategy into integrated CMC timelines and deliverables across projects and communicate the plan to all key stakeholders
- Conduct critical path analyses and pro-actively identify resource constraints / bottlenecks; continually work with the program team to review and address issues
- Support the CMC and Supply Chain team by organizing, scheduling, and facilitating CMC team meetings to review CMC Plans, CMC risks, CMC deliverables, and minute actions
- Ensure functional area "buy-in" and management approval for each CMC Plan and all updates
- Ability to communication CMC activities and strategy to senior management
- Develop and provide consistent project reporting to the CMC and Project Teams and CMC Project status reporting to Senior Management
- Serve as the main point of contact for all CMC project-related communications, fostering strong relationships with internal teams, and external partners
Skills and Qualifications :
Skills and Key Success Factors :
Alkeus Pharmaceuticals, Inc., is an equal opportunity employer and considers all qualified applicants for employment without regard to any characteristic protected by applicable law. We celebrate diversity and are committed to creating an inclusive environment for all employees.
