Clinical Scientist Oncology

Excelya; Palaiseau; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

Excelya is seeking a clinical scientist to provide scientific and clinical oversight for an ongoing Phase I/II solid tumor study. You will review patient-level safety/efficacy data, support CSR activities, and collaborate across Clinical Operations, Data Management, Statistics and CROs to ensure high-quality study execution.

The role requires strong experience in oncology development, proficiency with RECIST, and a track record in data cleaning and trial documentation.

Qualifications

• PharmD, PhD or equivalent in Life Sciences or related field.
• Strong experience in Clinical Development within pharma/biotech.
• Experience in Oncology Clinical Development, preferably solid tumors.
• Experience with combination therapies involving immunotherapy, targeted therapies, and/or chemo.
• Experience in clinical data review, patient-level review and data cleaning.
• Good understanding of oncology efficacy and safety endpoints like RECIST.
• Experience contributing to IB, DSUR, CSR and protocol amendments.

Responsabilités

• Provide scientific and clinical oversight of an oncology trial.
• Perform patient-level safety and efficacy data review and data cleaning.
• Support database lock preparation, study analyses and CSR activities.
• Coordinate DMC activities and centralized imaging review vendors.
• Contribute to protocol amendments, IBs, DSURs, ICFs and CSRs.
• Interpret results and support data-driven decision-making.
• Collaborate with Clinical Operations, Data Management, Statistics and CROs.

Connaissances

Clinical Development

Oncology

Solid Tumors

Combination Therapies

RECIST

Data Review

Study Documentation

Formation

PharmD or PhD in Life Sciences

Oncology Clinical Development experience

Outils

Veeva

Clinical Databases

Description du poste

Join Excelya, where Audacity, Care and Energy define who we are and how we work. We believe in creating ambitious solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role offers an exciting opportunity to join an Oncology Clinical Science team supporting an ongoing Phase I/II solid tumor clinical study evaluating targeted therapies, immunotherapies, and chemotherapy combinations. You will provide scientific oversight, contribute to patient-level data review, support study deliverables through database lock and Clinical Study Report (CSR) activities, and collaborate with cross-functional teams to ensure high-quality study execution.

Key Responsibilities

• Support the Clinical Lead and Study Team in the scientific and clinical oversight of an oncology clinical trial.
• Perform patient-level review of safety and efficacy data and contribute to data cleaning activities.
• Support database lock preparation, study analyses, and CSR development.
• Coordinate Data Monitoring Committee (DMC) activities and centralized imaging review vendors.
• Contribute to key clinical documents including protocol amendments, Investigator's Brochure (IB), DSURs, ICFs, and CSRs.
• Interpret study results and support data-driven decision-making.
• Collaborate with Clinical Operations, Data Management, Statistics, Safety, CROs, and investigational sites.
• Identify and proactively address study, data, or operational issues.
• Ensure all activities are conducted in compliance with ICH-GCP and applicable regulations.

• PharmD, PhD, or equivalent degree in Life Sciences, Biomedical Sciences, or a related field.
• Strong experience in Clinical Development within the pharmaceutical or biotechnology industry.
• Experience in Oncology Clinical Development, preferably in solid tumors.
• Experience with combination therapies involving immunotherapy, targeted therapies, and/or chemotherapy.
• Experience in clinical data review, patient-level review, and data cleaning.
• Good understanding of oncology efficacy and safety endpoints, including RECIST assessments.
• Experience contributing to clinical study documents (IB, DSUR, protocol amendments, CSR).
• Experience working with CROs, vendors, and cross-functional study teams.
• Experience with DMC activities or centralized imaging review is a plus.
• Fluent English (written and spoken).
• Experience with Veeva and clinical databases/listings is desirable.

Why join us?

At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.

Here's what makes us unique:

We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.

Our "one-stop provider" service model- combining full-service, functional service provider, and consulting- allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.

Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.