Vice President of Research & Development

About the role

The Lead Research & Development (R&D) organization is tasked with executing business strategies to ensure growth and meet sales and operating profitability goals. Reporting to the Chief Operating Officer, VP of R&D, this role oversees and enables innovation and product development across iPSC programming/line development, iCell portfolio, custom products, and CDMO services. As a key member of the Executive Leadership Team, the position focuses on creating agility and efficiency in resource management to ensure timely delivery of programs and initiatives.

Responsibilities

• Oversee and deliver on R&D milestones, including Discovery Research, new product development, CDMO milestones outlined agreements/SOWs, and DR custom projects
• Collaborate with Finance and Business Development to create and refine CDMO financial models to ensure profitable CDMO programs
• Plan and execute the development of new products and the improvement of existing products, in alignment with commercial team, and ensuring an efficient and effective NPI process is followed, and quality products are being released to the life science market
• Work closely with Executive team to develop and execute the long-term strategic business plan, ensuring communications to R&D team and alignment to goal setting process
• Manage departments’ annual budgets and quarterly forecasting processes. Ensure sound management of head count and expenses to meet approved spending plan while achieving all departmental commitments, project objectives, and to drive operating profit for the company
• Identify, develop, and deploy best practices across all R&D functions, including advancing opportunities for innovation, finding ways to enhance development and accelerate time to market
• Communicate and manage program status, initiatives, roadblocks, and recovery plans with Senior Management to achieve projects on time and on budget
• Facilitate where required, IND submissions and clinical development of partnered programs consistent with the highest regulatory standards
• Represent the company to prospective and current therapeutic/CDMO clients as the leader for iPSC and cell therapy development
• Drive innovation, ensuring FUJIFILM Cellular Dynamics stays a leader in advanced iPSC technologies and support to therapeutic developers
• Support early-stage programs, including technology transfer, clinical manufacturing support, IND submissions, in partnership with therapeutic clients
• Execute development programs and goals, developing and defining key “Go/No-go” criteria and managing matrix teams
• Proactively identify project issues and implement appropriate mitigation strategies. Ensure sound technical responses to information requests from regulatory bodies
• Implement key standard processes leading to positive and measurable impacts for clinical programs (e.g. quality, efficiency, consistency)
• Select, develop, train, and retain capable staff of development and operations professionals to ensure all aspects of the company objectives and timelines are achieved
• In collaboration with HLUS Compliance, support the business in compliance issues, collaborating with other departments to ensure sound business continuity and planning

Requirements

• PhD in cell biology, molecular biology, biochemistry, biomedical engineering, or related field – stem cell experience a plus
• Minimum of 15 years of R&D experience in the pharmaceutical, biotech, life science or CDMO industry with at least 10 years of management/leadership experience
• Relevant experience building high-performing, cross-functional teams responsible for optimizing portfolio delivery
• Strong familiarity with regulated pharmaceutical development and FDA, EMA, and other MOHs globally
• Ability to influence outcomes, utilizing effective communication skills across functions and on the executive team
• Demonstrated leadership capabilities to include a track record of hiring, retaining, developing and motivating top-tier scientific talent, team development, managing through adversity, effective communication across all levels of stakeholders to include external parties, all with a strategic outlook and ability to defend research positions while achieving program objectives
• Proven track record of driving accountability and fostering problem-solving within the team
• History of translating a corporate mission into specific team objectives, breaking down organizational boundaries through collaboration, building strong relationships based on trust with all levels of employees
• Ability to become a strategic partner with business leaders; contributes not only by identifying strategic opportunities for R&D, but also demonstrates an ability to think beyond the status quo and conceptualize innovative and visionary approaches to broad business challenges
• Proficient in R&D planning and driving execution through the team
• Demonstrated proficiency in managing multiple projects, and changing priorities meet timelines and budgets

Qualifications

• Domestic and international travel – 10%