General Scope and Summary
SAGE Therapeutics is searching for a creative, resourceful, integrative thinker for a highly visible role that is responsible for leading CMC project teams and collaborating closely with all involved functions, including Non-clinical Development, Clinical Development, Pharmaceutical Development, Technical Operations, Quality, Regulatory and Project and Portfolio Management to advance development compounds from preclinical to commercial stage.
Roles and Responsibilities
- Facilitates CMC team meetings and establishes detailed CMC program plans including activities, timelines and budgets in alignment with the overall development program and company goals
- Oversees execution of CMC-related development and manufacturing activities at external laboratories and manufacturing facilities
- Ensures effective communication, collaboration and documentation of all CMC aspects of the program, including preparation of reports and regulatory filings
- Identifies CMC-related risks and facilitates mitigation planning
- Actively communicates and collaborates with and contributes to other functional areas and drives timelines to achieve the best development and business results for the company
Experience, Education and Specialized Knowledge and Skills
The successful candidate has a broad understanding of analytical, chemical and formulation development, and a proven track record in CMC development for clinical stage programs. The successful candidate also understands the complexities of working in a highly regulated and quality driven environment. He or she possesses excellent leadership, communication and collaboration skills in a cross-functional and fast paced environment, as well as a proven ability to achieve results in a virtual setting with external laboratories and manufacturing facilities. Other requirements are:
- Advanced degree in Chemistry, Chemical Engineering or related field, Ph.D. preferred
- 8+ years relevant small molecule CMC experience in the pharmaceutical industry
- Strategic and leadership abilities as well as hands on problem solving skills
- Relevant project management and team leadership experience
- Excellent verbal and written communication skills, ability to effectively work across levels, functions and with both internal and external stakeholders.
- Experience in writing regulatory documents and submissions
- Embraces our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.
- Excitement about the vision and mission of Sage