Vice President, Regulatory Affairs and Quality

Vice President, Regulatory Affairs and Quality

• Company Address: 828 Winter St, Waltham, Massachusetts 02451, US

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 their therapeutic index by localizing anti-tumor activity within the tumor microenvironment, including tumor-activated cytokines and antibodies (including bispecifics) and immune cell engagers (including tumor-activated cell engagers and tumor-activated effector-enhanced cell engagers).

SUMMARY:

The Vice-President, Regulatory Affairs and Quality will work collaboratively with colleagues across the company, and with outside partners, to design and execute global registrations strategies for all Xilio products, including initial regulatory efforts on pipeline programs. The role is also accountable for furthering the development and providing oversight of Xilio’s quality systems and compliance strategies.

The high performing professional who fills this position must have a blend of strategic insight, functional expertise, leadership, people management and hands-on execution. The role requires someone who can immediately apply quality systems and regulatory compliance frameworks flexibly within an innovative environment. The Vice-President must engender credibility and confidence within and outside the company and do so as an effective communicator and collaborator.

The position will report to Xilio’s Chief Medical Officer, and join a talented and experienced clinical team. They will work closely with an extended team of external regulatory, quality, and clinical partners (consultants, contractors, and CROs). Additionally, the VP, Regulatory Affairs and Quality will be responsible for hiring a Director, Regulatory Operations, to report to them.

Job Responsibilities:

Regulatory strategy:

• Leads all regulatory activities for all assets to ensure alignment and compliance with local and regional GxP requirements and registration requirements as well as with company policies.
• Accountable for development and implementation of effective CMC regulatory strategies across products and product life cycles.
• Ensures stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Anticipates and manages risks.
• Monitors and anticipates trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.

Regulatory operations leadership:

• Hires, leads and coaches the Director, Regulatory Operations, the person with primary responsibility for developing systems and processes for regulatory operations, working with vendors as needed, to assure compliant, scientifically valid submissions, globally.
• Partners with the Director, Regulatory Operations and external partners to ensure that all regulatory submissions, archives, and requirements are well executed.
• Oversees the Director, Regulatory Operations in working with cross-functional teams to compile regulatory filing documents and maintain electronic/paper files to support all documentation systems.

Quality:

• Accountable for comprehensive quality management strategy to ensure compliance with regulatory requirements, including FDA and other relevant authorities.
• Interprets regulations, determines quality requirements, and works closely with internal cross-functional teams and external partners to execute quality strategy to support overall product quality.
• Develops and implements standards, policies, and procedures for GMP, GLP and GCP compliance, doing so in a way that engenders support and full participation of stakeholders.
• Partners with all line functions to ensure GMP, GLP and GCP compliance for all clinical development programs by providing guidance and serving as an expert in the interpretation regulatory requirements and expectations.
• Oversees and manages vendors supporting quality and compliance.

Function leadership and budget:

• Manages budget within financial goals; reviews and approves invoices against approved budget.
• Aligns functional growth (e.g., hiring, outsourcing, budgets) with company growth and changes consistent with guidance from Xilio leadership.

Skills, Qualifications, and Requirements:

• BS in a scientific/engineering discipline. Advanced degree preferred.
• At least 15 years of experience in biotechnology/pharmaceutical industry.
• 10+ years of experience in Regulatory strategy, with experience in Oncology Development preferred.
• Expert knowledge of relevant FDA, EU, ICH guidelines and regulations related to Oncology programs.
• Experience as primary regulatory author for IND and CTA documents.
• Strong experience with CTD format and content regulatory filings. Preferred: Delivery of at least one major application (NDA/BLA/MAA/JNDA etc.).
• Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide development teams in building appropriate global regulatory strategy.
• Able to handle multiple assignments in a fast-paced environment with changing priorities.
• Strong oral and written communications skills as well as presentation skills to leadership and peers at all levels.
• Role models respect, allyship and inclusion, creating a culture that fosters innovation and upholds Xilio values.

Diversity, Equity and Inclusion:

At Xilio Therapeutics, we foster a culture of equity, diversity and inclusion. We consider all qualified applicants without regard to race, color, sex, gender identity or expression, sexual orientation, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, or any other characteristic protected under applicable law. We will make reasonable accommodations, absent undue hardship, for qualified individuals with known disabilities. If you are an individual with a disability who requires an accommodation with the hiring process or to perform any essential functions of the position for which you are applying, please reach out to careers@xiliotx.com.

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