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 FIH, POM, ESOE, and POC in Oncology. Collaborate with the Global Development Lead and development teams to establish and execute early oncology clinical development plans, develop clinical protocols, and contribute as an individual on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

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

Qualifications

• Required: PhD or PharmD with minimum 5 years in a similar role in industry/CRO; or MS with minimum 7 years; or BS with minimum 10 years.
• Clinical Research experience in Phase 1 Oncology, sponsor-led.
• Strong understanding of Oncology Drug Development, especially Early Development.
• Knowledge of clinical procedures, ICH/GCP, and familiarity with FDA/EMA/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 with related disciplines (Clinical Ops, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA).
• Experience building consensus and driving change across organization levels; data listing review experience.
• Critical thinker; able to work in fast-paced matrix environment and independently; experience with complex data analyses using JReview, SpotFire, or similar platforms.

Skills

• Leadership and collaboration across cross-functional teams
• Strategic clinical development planning and execution
• Data analysis and interpretation for clinical trials
• Effective scientific writing and presentation

Education

• PhD or PharmD (required) or equivalent advanced degree as specified above.

Additional Requirements

• Travel: 5-10% travel; <10% travel in some cases.
• Work location: Hybrid role; on-site ~2.5 days/week within commuting distance.