Principal/Senior Clinical Data Scientist

pfm; États-Unis; À distance; USD 150 000 - 210 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Clinical data review

Leadership

Communication

Cross-functional collaboration

Formation

Bachelor's degree or equivalent in science/health

Nursing degree (RN)

Outils

Electronic Data Capture systems

Microsoft Office

Data visualization platforms

Description du poste

Role overview

A senior or principal-level clinical scientist role leading the clinical science function across oncology, rare disease, and autoimmune clinical development programs, from study start-up through database lock. The work centers on bringing scientific and indication-specific judgment to clinical trial data review, partnering with data management, biostatistics, medical monitoring, and other functional teams to keep participant data clean, protocol-compliant, and clinically meaningful.

Responsibilities

• Serve as the functional lead for clinical science on assigned studies from start-up through database lock, delivering against scope, timeline, and budget.
• Perform holistic and aggregate participant data review, applying clinical and scientific judgment to query management and clinically relevant data cleaning rather than relying only on programmed exclusion listings.
• Act as the clinical and scientific subject matter expert on study teams, guiding eCRF design, data capture requirements, edit checks, completion guidelines, EDC user acceptance testing, and ongoing review.
• Support Risk-Based Quality Management by identifying and addressing study risks, trends, and issues, and partnering with cross-functional teams on risk review.
• Collaborate with medical monitoring on participant data review findings and provide protocol-level scientific and operational input.
• Maintain clinical science project plans, guidelines, trackers, and programming specifications, and ensure applicable eTMF documentation is accurate.
• Contribute to study-level strategy, data review process improvements, and business development activities such as bid defense meetings, and review tables, figures, listings, or clinical study reports as needed.

Requirements

• Bachelor's degree or equivalent in a science or health-related discipline, with strong medical terminology.
• Minimum of 8 years of clinical research experience, or demonstrated competencies for the level.
• At least 3 years of recent oncology experience (within the past 1.5 years); familiarity with criteria such as CTCAE, ASTCT, RECIST 1.1, Lugano, and ICANS.
• At least 1 year of leadership experience, with a track record of mentoring and developing junior team members.
• High proficiency with Microsoft Office tools and strong written and verbal communication, including presentation of data, trends, and escalations.
• Working knowledge of FDA and ICH-GCP guidelines, relevant SOPs, and the broader clinical trial process, with the ability to operate independently in a global, cross-functional environment and escalating appropriately.

Nice to have

• A medical-related degree such as RN, OCN, PharmD, or RPh.
• Experience with Electronic Data Capture systems, database build, on-site clinical work, monitoring, or data visualization platforms.

Benefits and work setup

• Up to roughly 25% domestic and international travel, including overnight stays.
• Candidates must be legally authorized to work in the country of employment without employer sponsorship.