Director/Senior Director, New Products and Next Generation Program Leader
Lead the program and portfolio management activities for new products and the next generation of INTERCEPT products. Create the comprehensive product development strategy for new products currently in early development. Explore concepts and conduct feasibility on potential new products and next generation INTERCEPT products. Gain agreement with senior management on key program 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 plans and timelines for new products in cooperation with marketing, clinical, development, regulatory and project management functions to support corporate strategy.
- Explore concepts and conduct feasibility on next generation INTERCEPT products and potential new products. Make go/no go recommendations to senior management to initiate new development projects based on feasibility assessments.
- Drive clear early stage product development strategies that are aligned with corporate goals.
- Lead the New Products and Next Generation program leadership team and work with project management to ensure that program strategy is executed in accordance with communicated timelines and budgets.
- 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 New Products and Next Generation 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 and manufacturing partnerships, as needed. 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.
- Degree in a life science or engineering with a minimum of 10 years of experience in the biotechnology and/or medical device field, with 5 years of experience leading/managing early stage cross-functional development activities.
- Strong business skills essential, including proven track record of program leadership/management capabilities.
- 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, early stage product development of medical devices desirable.
- Ability to drive clear strategies that are aligned with corporate goals.
Excellent leadership, management and problem solving skills.