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

Role Summary

You will 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. You will work closely with the Global Development Lead and development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s), develop clinical protocols, and contribute as an individual contributor on clinical teams to meet enrollment and study delivery timelines.

Responsibilities

• Partner closely with the Global Development Lead in the execution of the clinical development strategy and plan for assigned molecules/indications.
• Provide scientific leadership and execution of clinical studies, deliver 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 data to 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 and external collaborators, investigators, and contractors.
• Support and assist in developing 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 other critical documents (CDPs, INDs, CSRs, IBs, SMARTs/SAPs, regulatory documents).
• Foster transparent, collaborative partnerships across teams and therapeutic areas.
• Coordinate with ORD and WRD organizations; develop collaborations with internal and external partners across disciplines.
• 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 latest clinical thinking and guidelines, manage recruitment, analysis, and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas.
• Perform other duties related to clinical programs and contribute to departmental initiatives as requested.

Qualifications

• Required: PhD or PharmD with a minimum of 5 years in a similar role in industry/CRO, OR
• Required: MS with a minimum of 7 years in a similar role in industry/CRO, OR
• Required: BA/BS with a minimum of 10 years in a similar role in industry/CRO
• Clinical Research experience in Phase 1 Oncology, as sponsor leading studies
• Experience in Oncology Drug Development, especially Early Development
• Strong knowledge of clinical procedures, ICH/GCP, and familiarity with FDA/EMA/global regulations
• Strong scientific writing and communication skills (written and verbal)
• Clinical document writing experience (protocol, ICD, IB, IND) and ability to understand complex data analyses
• Track record of scientific productivity (publications, posters, abstracts, presentations)
• Experience with related disciplines (Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA)
• Experience building consensus and driving change across all levels, including senior management
• Data listing review experience
• Critical thinker with ability to work in a fast-paced, matrix environment and independently when appropriate
• Experience performing complex data analyses using tools such as JReview, SpotFire, or SOCs-PRO

Skills

• Leadership and collaboration across cross-functional teams
• Strategic clinical development planning and execution
• Advanced data interpretation and data-driven decision making
• Scientific writing and presentation for internal and external audiences
• Regulatory understanding and cross-functional collaboration with Regulatory Affairs

Education

• PhD or PharmD with ≥5 years experience, or
• MS with ≥7 years experience, or
• BA/BS with ≥10 years experience

Additional Requirements

• 5-10% travel
• Hybrid work location; on-site approximately 2.5 days per week within commuting distance