Associate Director, Program Management
About The Position
This role involves the direct management of drug partner programs and projects from inception through commercial launch and life-cycle management. The Associate Director will be responsible for developing, tracking, analyzing, and communicating key performance indicators related to technical strategies, regulatory pathways, clinical build progress, project execution, and product development risks. The position supports all phases of the product development process, ensuring adherence to Design Control principles, gatekeeping, design freezes, design reviews, change control, and sign-offs. The role also focuses on identifying and implementing best practices, maintaining consistency in deliverables, and nurturing positive relationships with both pharmaceutical partners and internal colleagues. The Associate Director will maximize team skills to achieve goals, communicate clear expectations, identify and facilitate change for business and process improvements, and maintain awareness of evolving processes and potential risks. Embodying company values and fostering teamwork, diversity, and inclusion are also key aspects of this position.
Requirements
- Bachelor of Science in Engineering or Life Science
- Minimum 8 years of experience in medical devices, pharmaceuticals, and/or combination products
- Minimum 5 years of experience in product development activities/process
- Minimum 5 years of experience leading cross-functional, matrixed teams, including experience managing external customers/clients
- Minimum 3 years of experience directly managing resources, budget, milestones, and detailed activities for large-scale projects
- Minimum 3 years of experience managing people directly
- Experience in additional functional areas (e.g., quality, regulatory, human factors, engineering, manufacturing, or strategic marketing)
- 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
- Master of Business Administration (MBA) or Master of Science in Engineering/Life Science
- Project Management (e.g., PMP, CAPM, CPMP, or Project Director) Certification
- Six Sigma/Kaizen/Lean Certification and/or Training
- Experience directly managing customers, partnerships, alliances, or external contracts preferred
Responsibilities
- Direct management of 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 gatekeeping, design freezes, design reviews, change control, sign-offs, etc.
- Identify and implement best practices across program management team; 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
Manager
