Director, Program Management CMC

Avidity Bioscience’s Alliance & Program Management Department is growing and building infrastructure to solidify the discipline of CMC Operations within the company. The Director of CMC Program Management is responsible for providing program management leadership and operational support to multiple CMC project teams.  The individual will drive effective execution of CMC deliverables by the project teams in coordination with and support of program and corporate goals.  The ideal candidate is highly organized and passionate about building a strong team in a patient-centric environment.  

• Drive strategic planning, execution, and implementation of CMC program plans from process development to commercial launch in collaboration with CMC Leadership and cross-functional teams
• Partner with PM and CMC Leadership to build a robust and fully integrated CMC PM organization
• Establish strong relationships with internal and external/vendor partners to build high-performing teams that will create efficiencies and resolve challenges to achieve ambitious goals
• Lead matrix teams in a regulated GMP environment, partnering with Quality and Regulatory colleagues to ensure the products meet quality and safety specifications
• Build and monitor fully integrated project schedules capturing all manufacturing activities and resources needed in accordance with corporate goals, scope, budget, and risks
• Lead risk management of CMC programs, proactively identifying risks, developing strategies to address them appropriately, and driving the teams to overcome issues and challenges
• Facilitate and lead internal and partner/CDMO CMC meetings, including scheduling, developing agendas, writing and distributing meeting summaries, and tracking goals and action items to completion
• Develop and manage CMC programs budgets in coordination with CMC leads
• Create, organize, and maintain CMC documents for access by the project teams and coordinate timely CMC document review/approval to support development, manufacturing, Regulatory and Quality activities
• Implement new processes and process improvement initiatives designed to improve the efficiency and effectiveness of the Program Management function
• Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development

Preferred Education and Experience

     Advanced degree in a life sciences or job-related discipline with minimum 10+ years of industry experience required

     7-10 years of cross-functional leadership experience in CMC program management, including experience working with Quality systems and regulatory requirements; process validation and manufacturing of biologics experience preferred

• Strong understanding of drug development, including in-depth knowledge of CMC functions and the strategic and operational requirements from IND to commercial launch
• Demonstrated leadership skills with the breadth of professional experience and the drive to work with both internal and external partners to define and implement effective project management plans.
• Highly skilled at working collaboratively with cross-functional teams and contractors to drive results and meet company objectives, including ability to influence in a matrix organization
• Self-directed, accomplishment-driven individual with a strong sense of passion and urgency who can work both independently and in cross-functional team environments.
• Proven ability to manage competing priorities, budgets, and timelines in a fast-paced, rapid-growth environment
• Strong interpersonal, written, and verbal communication skills, with the ability to distill and effectively communicate key messages from complex discussions
• Project management and organizational skills, along with problem solving, negotiations skills, conflict resolution, and team building skills
• Technical proficiency with project management tools; strong computer skills and experience with software such as MS Project, SmartSheets, Excel and SharePoint
• A background in rare diseases, oligonucleotide or biologics therapeutics is preferred
• Exceptional organizational skills and attention to detail

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