Director, Oncology Early-Stage Clinical Scientist

Role Summary

Director, Oncology Early-Stage Clinical Scientist. Lead and coordinate the development of multiple studies of novel biological and small molecules for first in human, proof of mechanism, early signs of efficacy, and proof of concept studies in Oncology. Collaborate with the Global Development Lead and development team to establish and execute the early oncology clinical development plan(s). Lead clinical protocol development and contribute as an individual on clinical teams to meet enrollment and study delivery timelines. Ensure Oncology Early Stage Development scope is represented across study teams.

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, implementing 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, query data, and present findings to appropriate teams and stakeholders.
• Conduct data review, analysis, and interpretation with GDL, Clinical Safety, and Biostatistics.
• Serve as a technical resource for clinical issues raised by collaborators, investigators, consultants, and contractors.
• Support development of publications, abstracts, and presentations.
• Participate in project teams to support clinical development implementation and milestones, including start-up and delivery of ESoE and PoC trials.
• Lead preparation of clinical protocols and critical documents (CDPs, INDs, annual reports, CSRs, investigator brochures, SAPs, regulatory documents).
• Foster transparent collaboration across teams and therapeutic areas.
• Coordinate with ORD and WRD organizations; develop collaborations with internal and 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; manage recruitment, analysis, interpretation, and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical literature relevant to therapeutic areas.
• Perform other duties related to clinical programs and support departmental initiatives as requested.

Qualifications

• Minimum: PhD or PharmD with 5+ years in a similar role in industry/CRO; or MS with 7+ years; or BA/BS with 10+ years.
• Clinical Research experience in Phase 1 Oncology, sponsor-led studies.
• Experience/strong understanding of Oncology Drug Development, especially 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 clinical documents (protocols, ICDs, IBs, INDs) and understanding complex data analysis.
• track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience working with related disciplines (Clinical Ops, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA).
• Experience building consensus and driving change across organization levels; data listing review experience.
• Critical thinker; ability to work in fast-paced matrix environment and independently when needed.
• Experience performing complex data analyses using tools such as JReview, SpotFire, SOCs-PRO or similar.

Preferred Qualifications

• Experience leading a team.

Education

• Not specified beyond above qualifications.

Additional Requirements

• Travel: 5-10%
• Work Location: Hybrid