Director, Program, Partnership and Clinical Management, Device and Combination Products Development

The Director of Program Partnership and Clinical Management is responsible for leading a global team composed of two groups: Program and Partnership Managers and Clinical Systems Managers.

The Program and Partnership Managers lead cross-functional teams across Engineering Quality Supply Chain Marketing Operations Human Factors Project Management and external partners to execute a portfolio of projects focused on delivery system constituent parts of combination products.

The Clinical Systems Managers lead cross-functional teams in defining strategy and executing the implementation of devices including combination products and aesthetics devices into AbbVie clinical programs. This includes devices primary packaging accessories secondary packaging instructions for use and labeling.

The Director ensures that strategies and plans for assigned programs align with patient and customer needs as well as the business objectives of the PPDST and Asset teams. The Director reports to the Vice President of Device and Combination Products Development.

Responsibilities:

• Providing leadership that promotes inter-site collaboration and consistency
• Establishing clear leadership expectations to ensure all Project Management Leads provide:
  • Leadership of a portfolio of device and combination product development projects
  • Tactical and strategic management of external device partners including serving as a key interface managing the governance process and evaluating potential future partners
  • Effective representation of the R&D organization to cross-functional leadership through timely and clear communication
  • Effective use of meetings by defining objectives preparing agendas identifying the appropriate participants and publishing minutes and action items
• Establishing clear leadership expectations to ensure all Clinical Support Leads provide:
  • A strategic structure for the DCPD Clinical Management organization including development and leadership of a global team
  • Defined clinical roles and responsibilities across the team and the broader organization
  • An intake process for DCPD clinical management to track programs from initiation through completion
  • Close partnership with the DCPD leadership team to identify clinical management needs and drive excellence across the organization
• Maintaining accountability for compliance with applicable policies and procedures
• Managing device financial planning including budgeting forecasting and long-range planning for DCPD expenses and ensuring project-level expenses are appropriately budgeted and forecasted

Management of External Partners:

The Director ensures that Program Managers effectively manage relationships and performance with key external device development partners. A strong and efficient partner governance process should be defined and implemented including key interface definition meeting cadence schedule performance monitoring project scope and change control issue escalation and financial tracking.

Program risks must be identified and mitigated throughout the partner lifecycle. The Director also ensures timely and effective communication of partner performance to the broader AbbVie organization as addition the Director works with the AbbVie contracts team and external partners to define and track performance against the Statement of Work. The Director is responsible for providing accurate and timely cost estimates to support budgeting and forecasting.

Functional Management:

The Director directly manages a global group of Project Managers through effective delegation of responsibilities support for professional development and timely actionable performance feedback. This role also emphasizes continuous improvement in the teams project and program management capabilities as well as product development-related processes.

Impact on AbbVie:

This role has broad influence on the development and launch of AbbVie assets when a device or combination product delivery system is required. These systems are often technically complex involve multiple subsystems interface directly with the patient and must meet global requirements. External partner management is typically required.

The Director must represent the R&D function to cross-functional leadership through effective communication strong influence and sound judgment.

Qualifications :

• Bachelors degree in Engineering or a related technical field required
• Masters degree in Engineering or Business Administration preferred
• Project Management Professional (PMP) certification preferred but not required
• 15 years of experience in the medical device and/or pharmaceutical industry with demonstrated success in developing and launching combination products
• Experience managing external partnerships in the pharmaceutical and/or device environment
• Broad experience in design controls human factors studies design verification/validation and usability studies
• Proven leadership of technical professionals and cross-functional teams with a focus on commercialization equipment selection and build and qualification of delivery systems
• Strong experience initiating selecting coordinating and managing projects with the ability to solve complex and unique problems
• Strong conflict resolution skills including persuasive management techniques
• Effective communication and people management skills
• Ability to ensure timely execution of incoming reportable device combination product events in compliance with global regulations
• Relevant experience in the pharmaceutical product development lifecycle and/or device design history file project management and product development
• Experience with on-body delivery systems auto-injectors pumps and pre-filled syringes as well as smart packaging design preferred but not required
• Strong working knowledge and application of GMP principles concepts practices and standards as well as relevant regulatory requirements for commercialization in global markets including the United States Europe Asia and Latin America
• Ability to travel up to 25% to support communication across AbbVie sites and third-party suppliers

Additional Information :

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: 

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future. 

• We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.

• This job is eligible to participate in our long-term incentive programs. 

Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. 

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Work :

No

Employment Type :

Full-time