Director, Regulatory CMC
Director, Regulatory CMC
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Job Description
Director Regulatory CMC
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 follow us on LinkedIn (Xilio Therapeutics Inc.).
SUMMARY:
We are seeking an independent and scientifically driven Director of Regulatory CMC who will be responsible for overseeing global Chemistry Manufacturing Controls (CMC) regulatory affairs across Xilios pipeline. The ideal candidate is experienced in developing global regulatory CMC strategies and leading their execution across projects including submissions reviews and health authority interactions. This hire will have strong experience in monoclonal or bi-specific antibodies and the associated regulatory CMC requirements. This candidate will be a collaborative contributor capable of working in a small company environment and will be embedded in both the Regulatory and CMC teams. This position reports to the VP Head of Regulatory Affairs and will be an initial member of the Regulatory team with the opportunity to further broaden the candidates Regulatory experience.
Job Responsibilities:
- Design develop and implement global regulatory CMC strategies across programs.
- Partner with key functional counterparts and teams on the development of strategic CMC plans for Xilios pipelines.
- Provide relevant guidance and advice on regulatory CMC matters to internal teams and stakeholders to assure compliance with applicable regulations.
- Serve as a liaison for CMC with global regulatory authorities.
- Make recommendations for standard operating procedures (SOPs) best practices and procedures.
- Write review and coordinate to ensure timely submission of all regulatory CMC submission documents and responses to queries from worldwide regulatory authorities (e.g. INDs IMPDs BLAs MAAs).
Skills Qualifications and Requirements:
- Direct experience with leading CMC submission preparation and CMC-focused Health Authority interactions
- Minimum of 6 years of relevant US Regulatory CMC experience; global experience preferred
- Bachelors degree in a relevant scientific discipline required MS or PhD preferred.
- Experience with monoclonal or bi-specific antibodies preferred
- Strategic thinking and strong independent problem-solving skills
- Strong interpersonal skills and the ability to communicate effectively cross-functionally. Strong oral and written communication skills
- Sound understanding of CMC and GMP related issues
Equal Opportunity and Inclusion
Our human capital resources objectives include as applicable identifying recruiting retaining incentivizing and developing our existing and additional are committed to equal opportunity and inclusion across all aspects of our organization including in our recruitment advancement and development conduct annual performance and development reviews for each of our employees to discuss the individuals strengths and development opportunities career development goals and performance goals. We also regularly survey employees to assess employee engagement and addition each regular full-time employee is provided an allowance and time to attend appropriate job-related trainings and other professional development courses seminars meetings and similar sessions. If you are an individual with a disability who requires an accommodation with the hiring process please reach out to .
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Required Experience:
Director
Employment Type
Full Time
