Description

The Senior Director of Technical Innovation requires a combination of CMC technical expertise (e.g. gene therapy, RNA, gene editing), effective communication, business and strategic acumen. This leader will drive technical innovation by both enhancing and leveraging our Technical Operations capabilities to maintain our position as a world leader and change driver in the industry. This role will collaborate with internal stakeholders, including but not limited to: Process Development, Analytical Development, Manufacturing, Supply Chain, Quality, R &D, Business Development, Legal (IP and contracts) and Finance, as well as, external collaborators. Success in this role will be to advance Technical Operations’ platform through new technology and internal inventions; technical presence through publications, conferences, collaborations and industry consortiums; and strategic opportunities identified through data analytics and sciences.

Primary Responsibilities Include:

• Establishes formation of a centralized innovation framework, including creation and leadership of the strategy, forum, and process that drives implementation of new technology, and streamlines IP engagement
• Expands Sarepta Technical Operations presence through publications, speaking engagements participation in industry consortiums
• Screens, analyzes and negotiates potential technical collaborations from a scientific, financial and strategic perspective
• Drives identification and enablement of novel technologies and cross-functional Technical Operations improvements
• Serves as the liaison to Technical Operations scientific and business teams to provide proposals to senior leadership and prioritizes innovation in alignment with Sarepta and Technical Operations strategy
• Demonstrates influential leadership capabilities and fosters a collaborative team environment
• Leads organizational initiatives and represents Technical Operations on behalf of the organization
• Participates in project related teams and other internal/external collaborations to support Sarepta’s objectives

Desired Education and Skills: 

• Bachelor’s degree in Life Sciences or Engineering with 15+ years of relevant experience with 5+ years in a leadership role.  Advanced degree preferred.
• Experience in end-to-end CMC drug development from early to late-stage development, GMP clinical and commercial operations and regulatory submissions
• Proficient in GMP, GLP and regulatory guidelines related to pharmaceutical development
• Excellent communication and interpersonal skills to help build strong relationships across scientific and business functions
• Extensive experience with the process and principles of development, technical transfer, scale up design, drug substance/drug product unit operations, and analytical methods
• Excellent listener, seeks broad input and feedback, provides frequent and effective follow up
• Solid understanding of statistical design and modeling of experiments
• Experience leading negotiations and executing agreements (e.g. material, license, etc.)
• Must have effective written and verbal communication skills