Director/Sr. Director, Platelets & Plasma Program Leader

Lead the development programs for the INTERCEPT Blood Systems for Platelets and Plasma in this high visibility role.  Guide the comprehensive product development strategy for new label claims and expansions into new geographies for these critical programs.  Gain agreement from senior management on key objectives, project deliverables and timelines.  Coordinate with project team members and functional area heads to ensure optimal execution of strategy.  Interface with the commercial team to understand the needs of the market, and design and implement means to bring the best possible, high quality product to market as efficiently as possible.     

Primary Responsibilities:

• Lead the Platelets and Plasma cross-functional development teams.

• Drive clear product development strategies that are aligned with corporate goals.

• Create comprehensive product development and launch plans and timelines in collaboration with the development teams and the commercial organization to implement the strategy for approval, launch and adoption of the INTERCEPT Platelets and Plasma Blood Systems.

• Gain agreement from senior management on the recommended strategies, plans and timelines through the Portfolio Review Committee.

• Partner with Project Management to drive timelines to ensure that program strategy is executed in accordance corporate goals and with communicated deliverables.

• 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 the Intercept Platelets and Plasma Programs.

• Interact with internal departments to resolve project-related issues.

• Oversee design and development activities for the Platelets and Plasma development programs.

• As a member of the Program and Portfolio Management Department, assist in identifying tools and processes to enhance operational efficiency and cross-functional communication.

• Perform other related duties as required.

Qualifications/Requirements/Skills: 

• Masters degree or Ph.D. in life sciences or engineering with a minimum of 10 years of experience in the biotechnology and/or medical device fields.

• Proven track record of program leadership capabilities essential with strong business acumen.

• Demonstrated ability to make effective decisions in a complex, fast paced environment.

• Excellent oral and written communication skills.

• Experience in global projects and collaborative partnerships.

• 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.

• Excellent interpersonal skills.