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

• Lead the CMC strategy and program activities of internal and partnered capabilities critical for the successful advancement of Sarepta's Gene Therapy & RNA portfolio.
• Accountable for inter-dependencies across functions, between tech ops and clinical, non-clinical, quality, and regulatory to support execution of integrated program plans.
• Provide strategic and operational guidance on CMC aspects of programs, evaluating various scenarios and simplifying concepts and strategies, orally and in writing.
• 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.
• Develop and implement process(es) to ensure successful transition and alignment of the portfolio from research to development through commercial.
• Responsible for all operational aspects of assigned projects, including stakeholder management, project scope, strategy, risk, planning, resourcing and project direction, execution and closure.
• Seek cross-functional input and feedback; frequent and effective follow-up, and provide expertise in translating requirements into practical, workable plans.
• Identify interdependencies and connections between departments and ensure integrated end-to-end visibility and alignment.
• Maintain team focus on key priorities and motivate team members to work collaboratively to achieve objectives.
• Collaborate with Tech Ops project managers to implement tools and systems to ensure shared understanding of company priorities, objectives and project timelines.
• Define and manage critical path, proactively identify and escalate issues and help resolve them.
• Maintain detailed project documentation for knowledge management.
• 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.
• Inform group members, senior and/or executive management of industry-related updates and technical knowledge.

Requirements

• 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.
• 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.
• Exposure to a variety of modalities (small molecules, biologics, gene therapy, others) is preferred.
• Must have exceptional working knowledge of drug development and CMC technical operations and expertise in quality and regulatory areas is desired.
• Demonstrated excellence in cross-functional team leadership and effectively managing multiple projects/priorities, ensuring schedules and deliverables are met.
• Ability to manage ambiguity and troubleshoot critical issues or problems and resolves routine issues using appropriate information.
• 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.
• Exceptional oral and writing communications skills with the capacity to present effectively to a diverse range of audiences.
• 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

• Physical and Emotional Wellness
• Financial Wellness
• Support for Caregivers

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