Director, CMC Project Lead

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 Nonclinical 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

• Facilitate CMC team meetings and establish detailed CMC program plans, including activities, timelines, and budgets, in alignment with the overall development program and company goals.

• Oversee the execution of CMC-related development and manufacturing activities at external laboratories and manufacturing facilities.

• Ensure effective communication, collaboration, and documentation of all CMC aspects of the program, including preparation of reports and regulatory filings.

• Identify CMC-related risks and facilitate mitigation planning.

• Actively communicate with, collaborate with, and contribute to other functional areas and drive 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. This individual will possess 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.

Basic Qualifications

• Advanced degree in chemistry, chemical engineering, or a related field.

• 12+ years of relevant small molecule CMC experience in the pharmaceutical industry.

Preferred Qualifications

• PhD preferred.

• 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 and the ability to effectively work across levels, functions, and with both internal and external stakeholders.

• Experience in writing regulatory documents and submissions.

• Embrace our Core Values: Put People First, Improve Lives, Cultivate Curiosity, Do Right, and Forge New Pathways.

• Possess an excitement about the vision and mission of Sage as a leader in brain health.

All Sage new hires will be required to provide documentation that they are fully vaccinated against COVID-19 or, if not, that they are legally entitled to an accommodation due to a medical condition or a sincerely held religious belief.  Requests for accommodation will be considered on a case-by-case basis, and Sage will consider, among other things, whether the proposed accommodation would create an undue hardship.

All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.

EEO is the Law

EEO is the Law - Poster Supplement

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Sage Therapeutics, Inc.