Senior Pharmaceutical Development Program ManagerNew
About the position This is a primarily remote position and is open to remote applicants. At Kaléo, our way is not to seek to be like others, but rather to passionately pursue meaningful and innovative solutions for patients. We believe all people should have access to the innovative healthcare products and solutions that empower each of them to live fuller, bolder lives. The Sr. Pharmaceutical Development Program Manager is a key role for the Kaléo Innovation Group providing program management (PM) support across the company's drug/device platform programs including Medical Countermeasure and Pharmaceutical Collaborations. The Sr. Pharmaceutical Development Program Manager is also responsible for the coordination and management of development activities associated with commercial collaborations with potential pharma partners. The Sr. Program Manager (PM) is responsible for developing, budgeting, and managing the formulation fill/finish project portfolio for the Kaléo Development and Operations organization. The role also serves as a critical partner to subject matter experts (SME) for formulation fill/finish processes in development projects for new products and optimization/scale-up projects of approved products. The Sr. PM manages key projects on the Development and Operations register and helps facilitate projects managed by other internal and external operations personnel. This is a great opportunity for a detail-oriented project manager with proven success bringing pharmaceutical development projects across the finish line to grow their career in a dynamic, small-pharma environment with a big-pharma impact. Responsibilities • Implement project management processes, standards, tools, deliverables, and operational cadence as defined by the Kaléo Leadership team to ensure consistent execution of projects. • Perform initial project planning, including defining success, setting scope, ROI analysis, and budgeting. • Present projects to sponsors and Kaléo leaders for review and approval; communicate with leaders and senior management to obtain support and buy-in for projects. • Ensure functional alignment of projects between external stakeholders and internal Kaléo leadership. • Manage project scopes and deliverables through a change management process to ensure stakeholder requirements are met. • Manage Contract Development and Manufacturing Organizations (CDMOs) in delivering on project commitments. • Report on project progress routinely and as required. • Provide direct project management for key projects. • Provide oversight of resource allocations assigned to projects and aid in resource augmentation or leveling as required. • Escalate project issues or roadblocks to Kaléo sponsors and/or stakeholders for resolution. Requirements • Bachelor's degree in business, engineering, or a technical field. • Experience with pharmaceutical drug development and/or device manufacturing of combination products. • A minimum of 5 years of project management experience, preferably within a pharmaceutical drug or device development function. Nice-to-haves • Ph.D. in chemistry, pharmaceutical chemistry preferred. • Project Management Professional (PMP) certification preferred. • Experience with management of external CDMOs / other vendors preferred. Apply tot his job