Vice President, Regulatory Affairs and Quality

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). Learn more by visiting www.xiliotx.com and follow us on LinkedIn (Xilio Therapeutics, Inc.)

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 the 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. Her/She/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, Regulator 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.

#LI-NM1

Apply for this Job

* Required

First Name *

Last Name *

Email *

Phone *

Location (City)

Resume/CV *

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Cover Letter

Dropbox Google Drive

(File types: pdf, doc, docx, txt, rtf)

Preferred Name *

How did you hear about this job? *

Are you Authorized to work lawfully in the United States *

Will you now or in the future require Xilio to commence (“sponsor”) an immigration case in order to employ you (for example, H-1B or other employment-based immigration case)? *

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Xilio Therapeutics’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Gender

Are you Hispanic/Latino?

Please identify your race

Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Veteran Status

Voluntary Self-Identification of Disability

Form CC-305

Page 1 of 1

OMB Control Number 1250-0005

Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

Alcohol or other substance use disorder (not currently using drugs illegally)
Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
Blind or low vision
Cancer (past or present)
Cardiovascular or heart disease
Celiac disease
Cerebral palsy
Deaf or serious difficulty hearing
Diabetes
Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
Epilepsy or other seizure disorder
Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
Intellectual or developmental disability
Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
Missing limbs or partially missing limbs
Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
Partial or complete paralysis (any cause)
Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
Short stature (dwarfism)
Traumatic brain injury

Disability Status

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Enter the verification code sent to to confirm you are not a robot, then submit your application.

Security Code *

This application was flagged as potential bot traffic. To resubmit your application, turn off any VPNs, clear the browser's cache and cookies, or try another browser. If you still can't submit it, contact our support team through the help center.