Vice President, Clinical Development

1 month ago

Waltham, United States Xilio Therapeutics Full time

Vice President, Clinical Development

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 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 careers@xiliotx.com.

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