Vice President, Clinical Development

Waltham, MA, United States

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

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SUMMARY:

The Vice President Clinical Development leads and sets the strategic direction for a group of medical team leaders in Clinical Development. This position is closely partnered with SVP, Clinical Operations to strategically design and execute clinical studies aiming to deliver new treatment options to patients, and works closely with all functions across discovery research, non-clinical development, manufacturing, clinical pharmacology, translational science pharmacovigilance, regulatory, medical affairs and commercial. Additionally, the Vice President Clinical Development interacts closely with the Xilio Executive Team. The Vice President will over time build and manage a team of physicians and scientists in Clinical Development organization. This role reports directly to the CMO.

Responsibilities:

Accountable for the strategic vision to brings new treatment options to patients, including clinical development plans

Work with Regulatory colleagues to develop registrational plans for emerging assets

Accountable for clinical development plans and, in partnership with Clinical Operations, data generation through the execution of clinical protocols

In partnership with Medical Affairs, accountable for external scientific communication, including scientific publication and presentations

Over time build, manage and mentor a team of physicians and clinical scientists

Serve as the clinical leader on joint steering committees that are responsible for external partnerships and drive to desired outcomes

Provide clinical and translational advice to our early project teams as they assess novel targets and consider potential clinical indications and paths forward

Motivates and leads a group of physician and non-physician scientists (contractors, CRO teams, and as company grows, internal positions)

Represent Xilio at key national and international medical and scientific meetings including participation and/or leadership of advisory boards in collaboration with medical affairs

Maintain and expand Xilio’s network of external clinical collaborators and advisors, both in the academic and community settings

Oversees and participates in public presentations and publications of the company’s clinical data for each program

Accountable for administrative functions and budgets

15% travel, predominantly domestic

Required Qualifications:

Board certified M.D. or M.D./Ph.D. or equivalent with development experience in Oncology, or other relevant disease areas

Strong leadership skills and demonstrated biopharmaceutical industry experience developing, planning, designing, and executing early and late-stage programs, creating submissions for health authority approvals, and taking products from development through commercialization

Experience and comfort with highly complex and dynamic clinical trial designs.

Strong working knowledge of the application of biostatistical principles to clinical trial design

5+ years of demonstrated ability in the biotechnology or pharmaceutical industry including direct experience leading and a detailed understanding of the drug development process from IND through NDA and the post-marketing setting

Experience presenting to a wide variety of audiences including internal teams, patient advocacy groups, medical/scientific communities, and investors

Strong working knowledge of the FDA and EMA

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 [email protected].

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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 hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential 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.

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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 measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis 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.

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