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

Role Summary

Oncology Early Stage Clinical Scientist (Director, Non-MD) leads and coordinates the development of multiple studies of novel biological and small molecules in Oncology, across FIH, POM, ESOE, and POC programs. Partners with the Global Development Lead to establish and execute early oncology clinical development plans, lead clinical protocol development, and contribute as an individual on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

• Partner 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, driving innovative trial 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 trends, and present findings to 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 and contractors.
• Assist in development of publications, abstracts, and presentations.
• Participate on project teams to support clinical development implementation and milestones (e.g., start-up and delivery of ESOE and PoC trials).
• Lead preparation of clinical protocols and related documents (CDPs, INDs, CSRs, IBs, SAPs, regulatory documents).
• Foster a collaborative environment across teams and therapeutic areas.
• Coordinate with ORD and WRD activities; develop collaborations with internal and external partners across functions.
• 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 current guidelines and manage recruitment and data interpretation.
• 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

• Relevant PhD or PharmD with a minimum of 5 years in a similar role in industry/CRO, OR
• MS with a minimum of 7 years in a similar role in industry/CRO, OR
• BA/BS with a minimum of 10 years in a similar role in industry/CRO
• Clinical research experience in Phase 1 Oncology on the sponsor side
• Strong understanding of Oncology Drug Development, especially Early Development
• Knowledge of clinical procedures, ICH guidelines, GCP; familiarity with FDA/EMA/global regulations
• Strong scientific writing and communication skills
• Experience with clinical document writing (protocols, ICDs, IB, IND) and complex data analysis
• Track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience collaborating with Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA
• Ability to build consensus and drive change across levels, including senior management
• Data listing review experience
• Critical thinker with ability to work in a fast-paced matrix environment and independently as needed
• Experience performing complex data analyses using JReview, SpotFire, or similar platforms

Skills

• Scientific writing
• Clinical data analysis and interpretation
• Cross-functional collaboration and leadership
• Regulatory and clinical development knowledge

Education

• PhD/PharmD or MS/BA with relevant industry experience as listed above

Additional Requirements

• 5-10% travel
• Hybrid work location requiring on-site presence ~2.5 days per week within commuting distance