Executive Director, Device Technical Operations

Job Description

The Executive Director, Device Technical Operations is a pivotal leadership role within the Device Development & Technology (DD&T) organization in our Research Division. This position is responsible for providing strategic oversight, leadership for the technical transfer portfolio for medical devices and combination products, as well as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning multiple development projects and inline products across a range of delivery technologies. 

This role is accountable for the portfolio of projects ensuring a successful scale-up/scale-out, commercialization, and transfer of medical devices and combination products into the manufacturing sites ensuring a robust supply. The role is accountable for ensuring each inline team has robust lifecycle-management plans, appropriate and rigorous technical support processes to support manufacturing sites, proactive risk management, performance monitoring, and continuous improvement. Experience with autoinjectors, prefilled syringes, and other drug delivery systems, or equivalent is required. 

Key needs for this role include:

• Exceptional stakeholder management and partnering skills across multiple divisions, functions, and research and manufacturing sites. 

• Building and hiring talent, developing team’s subject matter expertise, and strengthening leadership influence while fostering a culture of inclusion and rapid systematic learning.

• Clarifying and ensuring clear lines of ownership and accountability for the work with stakeholders and partners.

• Enhancing portfolio management and oversight to ensure strong program plans, identifying key risks, and ensuring proactive postures to create future robustness.

Primary Responsibilities:

Business Savviness and Executional Excellence:

• Develop and communicate a clear vision and ensure execution of the strategy for the technical transfer of medical devices and combination products, aligning with the overall business objectives for launch preparedness and enhanced robustness, regulatory, and compliance requirements of the company.

• Provide executive leadership and direction for the technical transfer portfolio, ensuring that programs are effectively managed, resourced, and aligned with organizational goals.

• Demonstrate enterprise leadership by fostering collaboration across multiple teams and departments, ensuring that all efforts are synchronized towards common objectives.

Program Portfolio Management:

• Oversee the portfolio of technical transfer and inline programs, ensuring that all initiatives are executed efficiently and meet quality standards, timelines, and budgetary requirements.

• Drive resource allocation, prioritization of projects, and operational excellence across technical transfer initiatives, working collaboratively with the Senior Director, Directors, and Associate Directors, and cross-functional teams.

• Utilize enterprise leadership principles and ways of working to optimize team performance and enhance project outcomes through effective delegation and empowerment.

• Drive resource allocation, prioritization of projects, and operational excellence across inline program support projects, working collaboratively with the Senior Director, Directors, Associate Directors, and cross-functional teams.  Ensure in-line teams are appropriately monitoring the health of products and reacting to signals via data driven strategies.

Stakeholder Engagement and Communication:

• Foster strong relationships with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs, and external partners, to ensure alignment and collaboration on product support and tech transfer.

• Communicate effectively with senior leadership, governance committees, and the executive team, providing regular updates on program status, risks, and opportunities for continuous improvement.

• Leverage enterprise leadership principles and ways of working to influence and engage stakeholders at all levels, ensuring their commitment to the technical transfer vision.

Risk Management, Compliance Oversight & Decision Making:

• Lead the establishment of a robust risk management framework for technical transfer and inline programs, proactively identifying, assessing, and mitigating potential risks to ensure patient safety and product quality.

• Ensure compliance with all regulatory requirements and quality standards, serving as a subject matter expert in the medical device