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

Role Summary

Oncology Early Stage Clinical Scientist (Director, Non-MD) will 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, lead, coordinate, and execute the early oncology clinical development plans. Lead clinical protocol development and participate as an individual contributor on clinical teams to meet enrollment and study delivery timelines. Work with other functional groups to ensure Oncology Early Stage Development scope is represented within clinical study teams.

Responsibilities

• Partner with the Global Development Lead in the execution of the clinical development strategy and plan for assigned molecule(s)/indication(s).
• 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 the clinical data review strategy, ensure data quality, review emerging data and trends, query data, and present relevant data to teams and stakeholders.
• Conduct data review, analysis, and interpretation of clinical trials 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 the development of publications, abstracts, and presentations.
• Participate in project teams to support clinical development implementation and milestones (e.g., start-up and delivery of ESoE and PoC trials).
• Lead the preparation of clinical protocols and other critical documents including development plans, INDs, CSRs, ICDs, IBs, DPs, and regulatory documents.
• Foster a transparent environment that builds partnerships and trust among teams and therapeutic areas.
• Coordinate with Oncology Research Development and WRD; develop collaborations with internal and external partners.
• Partner with Translational Oncology and Biomarker teams to integrate biomarker plans for early efficacy signs and POC, and patient stratification.
• Establish and maintain relationships with external experts, regulators, and investigator networks to incorporate latest clinical thinking into plans and study designs, and manage recruitment, analysis, and presentation of results.
• Keep up-to-date with scientific and clinical literature in relevant areas.
• Perform other duties related to clinical programs and support department initiatives as requested.

Qualifications

• PhD or PharmD with a minimum of 5 years of experience in a similar role in industry/CRO, or MS with a minimum of 7 years, or BA/BS with a minimum of 10 years.
• Clinical Research experience in Phase 1 in Oncology, on the sponsor side.
• Experience in Oncology Drug Development, especially Early Development.
• Strong knowledge of clinical procedures, ICH guidelines, GCP, and familiarity with FDA, EMA, and global regulations.
• Strong scientific writing and communication skills; experience writing protocols, ICDs, IBs, INDs; ability to interpret complex data analyses.
• Track record of scientific productivity (publications, posters, abstracts, presentations).
• Experience with related disciplines such as Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance.
• Experience building consensus and driving change across all levels of the organization; 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 tools such as JReview, SpotFire, or SOCs-PRO.

Skills

• Leadership and collaboration across cross-functional teams
• Strategic clinical development planning and execution
• Data review and interpretation
• Scientific writing and communication
• Biomarker integration and translational collaboration
• Regulatory documentation and compliance

Education

• PhD/PharmD or MS/BA with relevant industry experience as noted in qualifications

Additional Requirements

• 5-10% travel
• Hybrid work assignment requiring onsite presence ~2.5 days per week within commuting distance