Senior Program Manager
About The Position
This role is responsible for managing drug partner programs and projects from inception through commercial launch and life-cycle management. The Senior Program Manager will develop, track, analyze, and communicate key performance indicators on the program, including the effectiveness of technical strategies, regulatory pathways, clinical build progress, project execution, and product development risks. This position supports all phases of the product development process from Concept to Launch, understanding Design Control principles and supporting gate-keeping, design freezes, design reviews, change control, sign-offs, etc. The role involves identifying and implementing best practices on programs, ensuring consistency and thoroughness of deliverables, and developing, maintaining, and nurturing positive relationships with key stakeholders at pharmaceutical partners and internal colleagues. The Senior Program Manager will maximize team skills and experience to achieve program/project goals, identify business and process issues, facilitate change within the organization, and maintain awareness of new and changing processes on programs/projects. This role embodies company values and fosters teamwork, diversity, and inclusion.
Requirements
- Bachelor of Science in Engineering or Life Science
- Minimum 8 years of experience in a regulated industry, preferably at least 5 years in medical devices, pharmaceuticals, and/or combination products
- Minimum 3 years of experience in product development activities/process
- Minimum 3 years of experience leading cross-functional, matrixed teams; experience managing external customers/clients preferred
- Minimum 3 years of experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
- Experience managing people directly
- Experience working directly with ISO, FDA, MDD, and/or other healthcare industry regulations and standards
- Proficiency utilizing Microsoft Office suite (Word, Excel, PowerPoint, Project)
Nice To Haves
- Experience directly managing customers, partnerships, alliances, or external contracts
- Experience in additional functional areas (e.g., quality, regulatory, human factors, engineering, manufacturing, or strategic marketing)
- Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
- Project Management (e.g., PMP, CAPM, CPMP, or Project Director) Certification
Responsibilities
- Manage drug partner program(s) and project(s) from inception through commercial launch and life-cycle management (i.e., product retirement); develop, track, analyze and communicate key performance indicators on the program, including the effectiveness of technical strategies, regulatory pathways, clinical build progress, project execution, and product development risks (e.g., alignment to schedule, scope, resources)
- Support all phases of the product development process from Concept to Launch; understand Design Control principles and support gate-keeping, design freezes, design reviews, change control, sign-offs, etc.
- Identify and implement best practices on programs; ensure consistency and thoroughness of deliverables throughout program
- Develop, maintain, and nurture positive relationships with key stakeholders at pharmaceutical partners; serve as ambassador for program; inspire confidence with pharma partner
- Develop, maintain, and nurture positive relationships with internal colleagues; demonstrate high level of interpersonal skills in interactions; work autonomously and exercise good judgement
- Maximize team skills and experience to achieve program/project goals; communicate clear expectations to team members in order to meet deadlines
- Identify business and process issues; facilitate change within the organization; model a culture of quality and continuous improvement
- Maintain awareness of new and changing processes on programs/projects; identify potential risks for pharmaceutical partners; implement necessary changes to maintain compliance
- Embody Enable values
- Foster teamwork, diversity, and inclusion within team, between teams and other groups
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What This Job Offers
Job Type
Full-time
Career Level
Senior
