Sr. Clinical Scientist

Clinovo; United States; On-site; USD 120,000 - 170,000; Full time

Job summary

Clinovo is seeking a Clinical Scientist with oncology experience to drive design, execution, and reporting of clinical studies in support of regulatory approvals for precision oncology programs.

You will collaborate cross-functionally, prepare regulatory submissions and publications, review study documents, and contribute to data interpretation and training materials, ensuring highest ethical standards.

Qualifications

• 5+ years of experience in biotechnology or pharmaceutical industry with oncology clinical trials.
• Experience designing, executing, interpreting, and/or reporting clinical trials in oncology.
• Familiarity with IND through NDA regulatory processes and guidelines.

Responsibilities

• Supports development and revision of clinical development plans with the medical director and evidence review.
• Leads cross‑functional development of protocols, study documents, and medical writing oversight.
• Writes/reviews clinical sections of regulatory submissions and periodic reports.
• Compiles clinical data summaries and assists interpretation of analyses.
• Contributes to publication planning and abstracts/presentations.

Skills

Oncology clinical development

Cross-functional collaboration

Clinical data analysis

Regulatory submissions knowledge

Trial design and execution

Job description

The Clinical Scientist will have experience in oncology clinical development. This position will collaborate cross-functionally and provide hands‑on contributions to the design, execution, and reporting of clinical studies, paving a path towards regulatory approval of our precision medicines for oncology targets.

Responsibilities:

• Supports the development and revision of clinical development plans (working closely with the medical director, performs literature reviews, competitive landscape analysis, and/or coordinates biostatistical and other subject matter expert input)
• Leads cross‑functional development of protocols, protocol amendments, Investigator’s Brochure, clinical study reports, and other key clinical development documents (authors and/or oversees medical writer)
• Writes and/or reviews clinical sections of regulatory applications, submissions, periodic reports, and responses, including responses to EC/IRBs inquiries as appropriate
• Compiles periodic clinical data summaries and assists in interpretation of analyses
• Member of publication planning team; may lead development of clinical abstracts, presentations, and publications
• Ensures methodology for data collection, cleaning, and analyses appropriately enable clinical program goals (may include collaboration with translational development and pharmacology)
• Performs clinical data review and contributes to data cleaning efforts
• Contributes to development of training materials
• Reviewer of key study documents and manuals (CRF, statistical analysis plan, imaging charter, ICF, data management plan, etc.)
• Serves as program team resource: identifies issues and inefficiencies, recommends solutions to challenges, and provides further guidance as needed
• Assists in the creation and continuous improvement of Clinical Development work processes
• Ensure consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations and laws

Qualifications:

• 5+ years of experience in the biotechnology or pharmaceutical industry including the design, execution, interpretation and/or reporting of clinical trials in oncology.
• Thorough understanding of the drug development process from IND through NDA, including familiarity with regulatory guidelines and best practices related to clinical trials design, analyses, and reporting.