Oncology Early Stage Clinical Scientist (Director, Non-MD)

Role Summary

Oncology Early Stage Clinical Scientist (Director, Non-MD) lead and coordinate the development of multiple studies of novel biological and small molecules for first in human (FIH), proof of mechanism (POM), early signs of efficacy (ESOE) and proof of concept (POC) studies in Oncology. Collaborate with the Global Development Lead and development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). Lead the development of clinical protocols and participate as an individual contributor on clinical teams to meet enrollment and study delivery timelines. Work with other functional disciplines to ensure the full scope of Oncology Early Stage Development is represented within clinical study teams.

Responsibilities

• Partner closely with the Global Development Lead in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s).
• Provide scientific leadership and execution of clinical studies, delivering innovative study designs, high-quality trial execution, safety assessment, and interpretation of results.
• Support execution for all FIH programs through proof-of-concept.
• Set the clinical data review strategy, ensure data quality, review emerging data and trends, query data, and present findings to relevant teams and stakeholders.
• Conduct data review, analysis, and interpretation of trial data with the GDL, Clinical Safety, and Biostatistics.
• Serve as a technical resource for clinical issues raised by internal/external collaborators, investigators, consultants, and contractors.
• Support development of publications, abstracts, and presentations.
• May participate on project teams to support clinical development implementation and milestones (start-up and delivery of ESOE and POC trials).
• Lead preparation of clinical protocols and related critical documents (development plans, INDs, CSRs, IBs, SDSPs, regulatory documents).
• Foster transparent collaboration across teams and therapeutic areas.
• Coordinate with Oncology Research Development and WRD; develop collaborations with internal/external partners.
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signs, POC, and patient stratification.
• Establish relationships with external experts, regulators, and investigator networks to integrate clinical thinking and guidelines into plans and study designs; manage recruitment, analysis, interpretation, and presentation of results.
• Maintain up-to-date knowledge of scientific literature and clinical development issues.
• Perform other duties related to clinical programs and support departmental initiatives as requested.

Qualifications

• Required: PhD or PharmD with a minimum of 5 years in a similar role in industry/CRO, OR MS with a minimum of 7 years, OR BA/BS with a minimum of 10 years in a similar role.
• Clinical Research experience in Phase 1 Oncology, as sponsor leading studies.
• Experience or strong understanding of Oncology Drug Development, especially in Early Development.
• Strong knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA, EMA, and global regulations.
• Strong scientific writing and communication skills; experience writing protocols, ICDs, IBs, INDs; ability to analyze complex data.
• Track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience across related disciplines (Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA).
• Experience building consensus and driving change across levels of the organization, including senior management.
• Data listing review experience.
• Critical thinker; capable of working in a fast-paced, team-based matrix and independently when needed.
• Experience performing complex data analyses using tools such as JReview, SpotFire, SOCs-PRO or similar.

Skills

• Leadership and cross-functional collaboration
• Clinical development strategy and data interpretation
• Clinical study design and protocol development
• Biomarker integration and translational collaboration
• Regulatory document preparation and communication
• Data analysis and statistical understanding

Education

• PhD or PharmD or MS/BA with equivalent industry experience as specified above

Additional Requirements

• 5-10% Travel
• Hybrid work location requiring on-site presence about 2.5 days per week and commuting distance