Director, CMC Project Lead
About the position The Director will lead cross-functional teams within Technical Operations to deliver the CMC development of Sarepta's Gene Therapy and RNA portfolio. Working as a member of the Global Program Team, he/she will be responsible for providing program management and leadership of CMC activities, working closely with internal technical functions and external partners. He/she will be a recognized expert in drug development with knowledge of phase appropriate Quality systems and global Health Authority requirements and will manage the logistical and operational aspects of programs in pre-clinical, clinical, registrational, or commercial stages. The position requires in-depth interactions with technical experts, quality and regulatory experts, researchers, manufacturing, and distribution teams from various functions. Responsibilities β’ Lead the CMC strategy and program activities of internal and partnered capabilities critical for the successful advancement of Sarepta's Gene Therapy & RNA portfolio. β’ Accountable for inter-dependencies across functions, between tech ops and clinical, non-clinical, quality, and regulatory to support execution of integrated program plans. β’ Provide strategic and operational guidance on CMC aspects of programs, evaluating various scenarios and simplifying concepts and strategies, orally and in writing. β’ Partner with global development teams and governance committees as tech ops lead and serve as the liaison to articulate and negotiate CMC strategy with the overall asset strategy. β’ Develop and implement process(es) to ensure successful transition and alignment of the portfolio from research to development through commercial. β’ Responsible for all operational aspects of assigned projects, including stakeholder management, project scope, strategy, risk, planning, resourcing and project direction, execution and closure. β’ Seek cross-functional input and feedback; frequent and effective follow-up, and provide expertise in translating requirements into practical, workable plans. β’ Identify interdependencies and connections between departments and ensure integrated end-to-end visibility and alignment. β’ Maintain team focus on key priorities and motivate team members to work collaboratively to achieve objectives. β’ Collaborate with Tech Ops project managers to implement tools and systems to ensure shared understanding of company priorities, objectives and project timelines. β’ Define and manage critical path, proactively identify and escalate issues and help resolve them. β’ Maintain detailed project documentation for knowledge management. β’ Identify issues and obstacles that could impact the timely advancement of CMC deliverables and resolve them with team members and/or relevant functional management both internally and externally. β’ Inform group members, senior and/or executive management of industry-related updates and technical knowledge. Requirements β’ Advanced degree (PhD or MS) with a minimum of 10 years, or Bachelor's degree with a minimum of 12 years, of experience in operations, project management and/or scientific area. β’ A minimum of 8 years of relevant experience advising and consulting senior leaders in biotech/pharma roles and experience working with senior level executives in biotech/pharma is advantageous. β’ Exposure to a variety of modalities (small molecules, biologics, gene therapy, others) is preferred. β’ Must have exceptional working knowledge of drug development and CMC technical operations and expertise in quality and regulatory areas is desired. β’ Demonstrated excellence in cross-functional team leadership and effectively managing multiple projects/priorities, ensuring schedules and deliverables are met. β’ Ability to manage ambiguity and troubleshoot critical issues or problems and resolves routine issues using appropriate information. β’ Ability to work well in a cross-functional, fast-paced team environment, build consensus and drive resolution of issues while maintaining positive working relationships across functions. β’ Exceptional oral and writing communications skills with the capacity to present effectively to a diverse range of audiences. β’ Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta cultural values: Patients First, Action, Unconventional Thinking, Talent and Integrity. Benefits β’ Physical and Emotional Wellness β’ Financial Wellness β’ Support for Caregivers Apply tot his job