Director / Sr. Director, CMC Project Management

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 strategiesLead the translation of strategy into integrated CMC timelines and deliverables across projects and communicate the plan to all key stakeholdersConduct critical path analyses and pro-actively identify resource constraints/bottlenecks; continually work with the program team to review and address issuesSupport the CMC and Supply Chain team by organizing, scheduling, and facilitating CMC team meetings to review CMC Plans, CMC risks, CMC deliverables, and minute actionsEnsure functional area "buy-in" and management approval for each CMC Plan and all updatesAbility to communication CMC activities and strategy to senior managementDevelop and provide consistent project reporting to the CMC and Project Teams and CMC Project status reporting to Senior ManagementServe as the main point of contact for all CMC project-related communications, fostering strong relationships with internal teams, and external partnersSkills and Qualifications:Requires a Bachelor's degree in relevant technical discipline and a minimum of 15 years of pharmaceutical industry experience, including a minimum of 10 years of CMC project management experienceAdvanced degree and/or PMI or PMP certification desiredMust have experience in project management techniques and principles including project planning, execution and tracking, risk identification, resource and financial project planningComprehensive understanding of the CMC development strategies across all phases of development and commercializationExperience with small molecules and oral solids dosage forms desiredStrong technical/analytical skills to identify and solve problems in a fast-paced environmentExperience in preparation and submission of regulatory documents in support of regulatory filingsExcellent oral and written communication skillsStrong organizational skills to maintain a high level of productivity, innovation, and setting priorities to complete assignments in a timely manner and within budgetDemonstrated ability to build relationships, influence, negotiate, and drive organizational engagementExperience developing and/or managing program management tools to forecast budgets, timelines and resources preferredExhibits high initiative, strong drive, and follow-throughStrong commitment to ethical standardsHigh level of commitment, flexibility and strong planning, coordination, teamwork, communication and interpersonal skillsExtensive intermediate to advanced computer skills (Microsoft Project, Microsoft Excel, Microsoft PowerPoint, and SmartSheet)Skills and Key Success Factors: Entrepreneurship spirit with a passion to build, learn and evolve with the team.Highly organized and detail oriented with a passion to deliver quality results.Demonstrated record of intellectual curiosity, innovation and creative problem solving with an entrepreneurial spiritAbility to lead fast-paced projects with a keen sense of urgency to get the job done wellEvidence of "hands-on" experience and expertiseProven and successful track record as a team-player and collaborator in small working environmentsHighest levels of professionalism, confidence, personal values, and ethical standardsAbility and aptitude to manage ambiguity and adaptability to changeEmphasize the need for self-motivation and the ability to work independentlyAlkeus 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.

Created: 2025-01-13