Lead Clinical Data Scientist - Oncology & Rare Diseases

pfm; United States; Remote; USD 150,000 - 210,000; Full time

Job summary

pfm is seeking a senior/principal clinical scientist to lead the clinical science function across oncology, rare disease, and autoimmune development programs from start-up to database lock.

You will bring scientific judgment to trial data review, partner with data management, biostatistics, and medical monitoring, and ensure data cleanliness and protocol compliance while driving meaningful clinical interpretations.

Qualifications

• Bachelor’s degree or equivalent in science/health with strong medical terminology.
• 8+ years of clinical research experience or demonstrated competencies.
• At least 3 years of recent oncology experience with familiarity of CTCAE, RECIST 1.1, Lugano, ICANS.
• At least 1 year of leadership experience mentoring/junior staff.
• Proficient with Microsoft Office; able to present data, trends and escalations.
• Working knowledge of FDA and ICH-GCP guidelines and global cross-functional operations.

Responsibilities

• Serve as the functional lead for clinical science on assigned studies from start-up through database lock.
• Perform holistic and aggregate participant data review with clinical judgment for data cleaning beyond programmed exclusions.
• Guide eCRF design, data capture requirements, edit checks, and UAT for EDC.
• Support Risk-Based Quality Management by identifying study risks and issues with cross-functional partners.
• Collaborate with medical monitoring on data review findings and protocol input.
• Maintain clinical science project plans, trackers, and programming specs; ensure eTMF accuracy.
• Contribute to study-level strategy, data review process improvements, and bid defense activities.

Skills

Clinical data review

Leadership

Communication

Cross-functional collaboration

Education

Bachelor's degree or equivalent in science/health

Nursing degree (RN)

Tools

Electronic Data Capture systems

Microsoft Office

Data visualization platforms

Job description

pfm is seeking a senior/principal clinical scientist to lead the clinical science function across oncology, rare disease, and autoimmune development programs from start-up to database lock.

You will bring scientific judgment to trial data review, partner with data management, biostatistics, and medical monitoring, and ensure data cleanliness and protocol compliance while driving meaningful clinical interpretations.