Xilio Therapeutics
Associate Director, Clinical Science
Xilio Therapeutics, Waltham, Massachusetts, United States, 02254
Associate Director, Clinical Science
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:
Xilio Therapeutics is looking for a Clinical Scientist who will be responsible for providing scientific support for clinical development activities for our clinical programs. You will play an integral role in clinical trial conduct and have accountability for clinical data and its quality. The dynamics of a small team will allow high visibility and an opportunity to shape the clinical team strategy and involvement in the preparation of scientific manuscripts and regulatory documents.
This position requires a strong scientific background preferably with a focus in Oncology and Immunology. You should be able to clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internal and external to the company. The Clinical Scientist should function independently, have good strategic insights and have knowledge of the activities and procedures involved in clinical drug development.
The Clinical Scientist will report to the Vice President, and will collaborate closely with clinical operations, data management and biostatistics, clinical pharmacology and program management.
Job Responsibilities:
In collaboration with Medical Monitors, provide strategic medical/scientific input and support to clinical development plans, clinical study protocols and other trial-related documents.
Develop strong working relationships with external investigators and research personnel to ensure optimal clinical study design, execution, and reporting; and serve as the primary point of contact for clinical research sites
Serve as the clinical partner to clinical operations, data management, biostatistics and programming, and provide critical input in the development of statistical analysis plans and case report forms.
Lead medical data review and be responsible for data integrity
Collaborate with the clinical development team on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting
Spearhead analysis and interpretation of clinical trial data in preparation for the development of clinical trial reports, investigator brochures, annual safety reports publications and internal/external presentations
Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations.
Prepare data and contribute to scientific publications including posters, abstracts and manuscripts.
Provide scientific input to the efficacy and safety endpoints of clinical trials.
Support the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
Proactively seek out and recommend process improvements.
Anticipate potential study problems and prepare contingency plans as needed.
Communicate clearly and precisely with all levels of the company.
Skills, Qualifications, and Requirements:
RN, MS, PhD or PharmD, or equivalent with clinical research experience.
4-7 years of technical/operational experience in planning, executing, reporting and publishing clinical studies.
Demonstrated experience leading medical data review and ensuring data integrity.
Strong knowledge of oncology drug development preferred.
A strong scientific background with industry clinical research experience is required.
Thorough understanding of ICH, GCP, and relevant regulatory requirements.
Strong analytical and strategic thinking skills.
Experience with interacting with clinical investigators and medical experts.
Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required).
Ability and willingness to travel up to 10%.
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 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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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:
Xilio Therapeutics is looking for a Clinical Scientist who will be responsible for providing scientific support for clinical development activities for our clinical programs. You will play an integral role in clinical trial conduct and have accountability for clinical data and its quality. The dynamics of a small team will allow high visibility and an opportunity to shape the clinical team strategy and involvement in the preparation of scientific manuscripts and regulatory documents.
This position requires a strong scientific background preferably with a focus in Oncology and Immunology. You should be able to clearly communicate concepts and information both in writing and via formal presentations to scientific and medical experts both internal and external to the company. The Clinical Scientist should function independently, have good strategic insights and have knowledge of the activities and procedures involved in clinical drug development.
The Clinical Scientist will report to the Vice President, and will collaborate closely with clinical operations, data management and biostatistics, clinical pharmacology and program management.
Job Responsibilities:
In collaboration with Medical Monitors, provide strategic medical/scientific input and support to clinical development plans, clinical study protocols and other trial-related documents.
Develop strong working relationships with external investigators and research personnel to ensure optimal clinical study design, execution, and reporting; and serve as the primary point of contact for clinical research sites
Serve as the clinical partner to clinical operations, data management, biostatistics and programming, and provide critical input in the development of statistical analysis plans and case report forms.
Lead medical data review and be responsible for data integrity
Collaborate with the clinical development team on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting
Spearhead analysis and interpretation of clinical trial data in preparation for the development of clinical trial reports, investigator brochures, annual safety reports publications and internal/external presentations
Provide support to advisory boards, consultant meetings and investigator meetings, including preparation and delivery of presentations.
Prepare data and contribute to scientific publications including posters, abstracts and manuscripts.
Provide scientific input to the efficacy and safety endpoints of clinical trials.
Support the development of program documents, including the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product approvals.
Proactively seek out and recommend process improvements.
Anticipate potential study problems and prepare contingency plans as needed.
Communicate clearly and precisely with all levels of the company.
Skills, Qualifications, and Requirements:
RN, MS, PhD or PharmD, or equivalent with clinical research experience.
4-7 years of technical/operational experience in planning, executing, reporting and publishing clinical studies.
Demonstrated experience leading medical data review and ensuring data integrity.
Strong knowledge of oncology drug development preferred.
A strong scientific background with industry clinical research experience is required.
Thorough understanding of ICH, GCP, and relevant regulatory requirements.
Strong analytical and strategic thinking skills.
Experience with interacting with clinical investigators and medical experts.
Excellent verbal, written, and interpersonal communication skills (fluency in written and spoken English is required).
Ability and willingness to travel up to 10%.
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 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
#J-18808-Ljbffr