Atlas Venture
About Xilio Therapeutics
Focused on harnessing the immune system to achieve deep and durable clinical responses to improve the lives of patients.
Job Description Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting
www.xiliotx.com
and follow us on LinkedIn (Xilio Therapeutics, Inc).
Summary We are seeking an independent and scientifically driven Director of Regulatory CMC to oversee global Chemistry Manufacturing Controls (CMC) regulatory affairs across Xilio’s pipeline. The ideal candidate has experience developing global regulatory CMC strategies and leading their execution, including submissions, reviews, and health authority interactions. The candidate should have strong experience with monoclonal or bi-specific antibodies and related regulatory CMC requirements. This role requires collaboration within a small company environment and reports to the VP, Head of Regulatory Affairs. It offers opportunities to broaden regulatory experience.
Job Responsibilities
Design, develop, and implement global regulatory CMC strategies across programs.
Partner with functional teams to develop strategic CMC plans for pipelines.
Provide guidance on regulatory CMC matters to ensure compliance.
Serve as liaison for CMC with global regulatory authorities.
Recommend SOPs, best practices, and procedures.
Write, review, and coordinate regulatory CMC submission documents and responses to authorities.
Skills, Qualifications, and Requirements
Experience leading CMC submission preparation and health authority interactions.
At least 6 years of US Regulatory CMC experience; global experience preferred.
Bachelor’s degree in a scientific discipline; MS or PhD preferred.
Experience with monoclonal or bi-specific antibodies preferred.
Strategic thinking and problem-solving skills.
Effective communication skills, both oral and written.
Understanding of CMC and GMP issues.
Equal Opportunity and Inclusion We are committed to diversity and inclusion in our recruitment, development, and retention practices. We conduct regular employee surveys and provide professional development opportunities to support our team members.
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Job Description Xilio Therapeutics is a clinical-stage biotechnology company discovering and developing tumor-activated immuno-oncology (I-O) therapies with the goal of significantly improving outcomes for people living with cancer without the systemic side effects of current I-O treatments. The company is using its proprietary platform to advance a pipeline of novel, tumor-activated clinical and preclinical I-O molecules that are designed to optimize the therapeutic index by localizing anti-tumor activity within the tumor microenvironment. Learn more by visiting
www.xiliotx.com
and follow us on LinkedIn (Xilio Therapeutics, Inc).
Summary We are seeking an independent and scientifically driven Director of Regulatory CMC to oversee global Chemistry Manufacturing Controls (CMC) regulatory affairs across Xilio’s pipeline. The ideal candidate has experience developing global regulatory CMC strategies and leading their execution, including submissions, reviews, and health authority interactions. The candidate should have strong experience with monoclonal or bi-specific antibodies and related regulatory CMC requirements. This role requires collaboration within a small company environment and reports to the VP, Head of Regulatory Affairs. It offers opportunities to broaden regulatory experience.
Job Responsibilities
Design, develop, and implement global regulatory CMC strategies across programs.
Partner with functional teams to develop strategic CMC plans for pipelines.
Provide guidance on regulatory CMC matters to ensure compliance.
Serve as liaison for CMC with global regulatory authorities.
Recommend SOPs, best practices, and procedures.
Write, review, and coordinate regulatory CMC submission documents and responses to authorities.
Skills, Qualifications, and Requirements
Experience leading CMC submission preparation and health authority interactions.
At least 6 years of US Regulatory CMC experience; global experience preferred.
Bachelor’s degree in a scientific discipline; MS or PhD preferred.
Experience with monoclonal or bi-specific antibodies preferred.
Strategic thinking and problem-solving skills.
Effective communication skills, both oral and written.
Understanding of CMC and GMP issues.
Equal Opportunity and Inclusion We are committed to diversity and inclusion in our recruitment, development, and retention practices. We conduct regular employee surveys and provide professional development opportunities to support our team members.
#J-18808-Ljbffr