Lead the program and portfolio management for the INTERCEPT Platelets & Plasma systems. Guide comprehensive product development strategy, gain agreement with senior management on key objectives and annual budgets, coordinate with leaders from functional departments and project team members to ensure optimal execution of strategy, interface with marketing and business development to understand the needs of the marketplace, and design and implement means to bring the best possible product to market as efficiently as possible.
• Create comprehensive product development and launch plans and timelines in cooperation with sales, marketing, clinical, development, regulatory and project management groups to create strategy for approval, launch and adoption of the INTERCEPT Platelets & Plasma Blood Systems.
• Drive clear product development strategies that are aligned with corporate goals and gain agreement of senior management on the recommended strategy.
• Lead the Platelet & Plasma program leadership team and work with project management to ensure that program strategy is executed in accordance with communicated timelines and to ensure budgets are met.
• Identify and communicate program risks and prepare mitigations and contingency plans.
• Gain corporate agreement on annual operational plan objectives and budget (e.g., milestones, resource requirements) for Intercept Platelets & Plasma Programs.
• Lead budgeting effort for the program, review activities and ensure all activities (up-side and down-side) are accounted for and documented.
• Work with project management to drive product development timelines and manage the budget across departments.
• Provide alliance management for development, manufacturing and commercialization partnerships. Provide leadership and coordination for joint steering and joint project teams.
• Interact with internal departments to resolve project-related issues.
• Interact with customers and key opinion leaders to understand the needs of the marketplace and define plans to meet those needs.
• Perform other related duties as required.
• Masters degree or Ph.D. in life science or engineering with a minimum of 10 years of experience in the biotechnology and medical device fields, with 5 years experience in management of product development and commercialization activities.
• Strong business skills essential, including proven track record of program management capabilities (MBA desirable).
• Demonstrated ability to make effective decisions in a complex environment.
• Excellent communication skills, including both oral and written communications.
• Experience in global projects and collaborative partnerships.
• Experience managing external suppliers and/or working in a virtual environment (e.g, CROs, CMOs, or engineering design and development contractors).
• Experience with corporate partnerships a plus.
• Experience with regulatory strategy, late-stage product development and product commercialization of medical devices desirable.
• Ability to drive clear strategies that are aligned with corporate goals.
• Excellent leadership, management and problem solving skills.