The Associate Director, CMC Project Management will lead the preparation of CMC project timelines, coordinate regulatory filings of Module 3 of IND, IMPD and responses to the Health Authorities, and provide CMC update to the leadership team. This position will have a direct report and will lead/coordinate CMC project team meetings. In addition, the successful candidate will collaborate with core program management and prepare overall program timelines from preclinical research to CMC development and clinical development. The candidate must have experience in using project management tools such as Microsoft Project, Spreadsheet and Gantt chart. This position will report to the Vice President, CMC.
Work with internal CMC subject matter experts and external vendor project managers, create and track timelines and activities on projects that span all CMC functions (Drug Substance, Drug Product, Analytical Development, Clinical Supply Operations, and Quality Assurance)
Proactively identify and communicate critical path, risks, and impediments to project timelines and objectives; drives the identification and development of solutions to mitigate the risks
Build strong cross-functional working relationships and ensure effective communication and collaboration among all project stakeholders
Facilitate regular internal project team meetings: create agendas, record meeting minutes and action items.
Develop and support internal collaboration, information sharing, project management, and knowledge management practices
Assist with creation and presentation of project updates to stakeholders with an appropriate level of detail and focus
Support CMC regulatory filings, responses, and commitments
Support CMC intellectual property documents and assets (e.g. patent applications for: drug substance manufacturing processes, polymorphs, and salt forms; drug product formulation)
Support the executive management team on stakeholder engagement issues as required
Track budgets, contracts, work orders, and other business processes
Provide project status updates and technical communications; smoothly execute the transfer of projects and data; ensure compliance with all requirements
Other Duties and Responsibilities:
Communicate with Medicinal Chemistry Group on CMC timelines
Keep CMC SharePoint
Collaboration & Teamwork: Advanced competence in collaboration & teamwork, communications influence, strategic agility, planning & organizing, driving results, and problem solving.
Productivity/Organizing/Planning: Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously.
Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback.
Leadership: Strong ability to establish and communicate clear visioning that team members willingly follow; provide information, knowledge and methods to realize that vision; coordinate and balance conflicting internal and external interests; ability to influence decision-making in a diplomatic manner. Able to navigate team smoothly through difficult situations.
Strategic Thinking: Capable of thinking conceptually, imaginatively, systematically, and opportunistically to achieve company goals.
Excellent communication ability in writing, speaking and presentation
Sound knowledge of CMC project management tools including Microsoft project, spreadsheet, and Gant chart
Knowledge of CMC operation in drug substance, drug product, analytical development
Ability to independently plan, organize and manage multiple projects simultaneously
Entrepreneurial and enjoys working in a fast-paced, innovative and resourceful small company environment
Up to 10% business travel
Education, prior work experience, and specialized skills and knowledge:
A minimum of 10-year experience with a BS degree or 8-year experience with a MS or Ph.D. degree in science majors in drug substance, drug product or analytical development
Demonstrated ability in collaboration & teamwork, communications influence, strategic agility, planning &organizing, driving results, and problem solving.
Excellent ability to convey both written and verbal information effectively and efficiently and presenting formation to all levels of audiences.
Willingness in learning new skills
Knowledge and experience with GMP, ICH, and other regulatory guidelines relevant to drug development and manufacturing
Familiar with project management methodologies and practices (PMBoK, PRINCE2, Agile, etc.); formal project management training and/or certification preferred
Knowledge and experience with regulatory writing is preferred
Proficient in Microsoft Office, Microsoft Project and/or similar applications; experience with other digital project management tools is a plus
Excellent communication, presentation, and information management skills
Demonstrated ability to work collaboratively and influence without direct authority
Demonstrated ability for critical thinking, systems thinking, and ability to foresee, prevent, and manage issues and conflicts
Enanta Pharmaceuticals, Inc.