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 to establish and execute the early oncology clinical development plan, develop clinical protocols, 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, innovative trial 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, and present findings to relevant 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 from internal and external collaborators.
• Support development of publications, abstracts, and presentations.
• Participate in project teams to support clinical development implementation and milestones (ESoE and PoC trials).
• Lead preparation of clinical protocols and critical documents including development plans, INDs, CSRs, IBs, SAPs, and regulatory documents.
• Foster transparent partnerships across teams and therapeutic areas.
• Coordinate with ORD and WRD, and develop collaborations with internal and external partners.
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signs and patient stratification.
• Establish relationships with external experts, regulators, and investigator networks to inform development plans and study designs.
• Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas.
• Perform other duties related to clinical programs and support departmental initiatives as requested.

Qualifications

• Required: PhD or PharmD with minimum 5 years in a similar role in industry/CRO; or MS with minimum 7 years; or BA/BS with minimum 10 years.
• Clinical Research experience in Phase 1 Oncology, on the sponsor side.
• Strong understanding of Oncology Drug Development, especially Early Development.
• Strong knowledge of clinical procedures, ICH, GCP; 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 Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA).
• Ability to build consensus and drive change across organizational levels; data listing review experience.
• Critical thinker with ability to work in fast-paced team-based matrix environments; capable of independent work.
• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or similar.

Skills

• Leadership and collaboration across multiple functional areas.
• Scientific writing and data interpretation.
• Clinical trial design and data analysis.
• Regulatory knowledge and cross-functional coordination.

Education

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

Additional Requirements

• 5-10% travel; hybrid work location.
• Must be able to perform complex data analysis.