Director, Oncology Early-Stage Clinical Scientist

Role Summary

Director, Oncology Early-Stage Clinical Scientist. 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 in close collaboration with the Global Development Lead (GDL) and members of the development team to establish, lead, coordinate, and execute the early oncology clinical development plan(s). You will lead the development of the clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and the project team, to meet enrollment and study delivery timelines. You will also work with other functional disciplines to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as needed within clinical study teams (e.g. Research Units, Biostatistics, Clinical Pharmacology, Precision Medicine, and Digital Medicine).

Responsibilities

• Partner closely with the Global Development Lead (GDL) in the execution of the clinical development strategy and plan for the assigned molecule(s)/indication(s).
• Lead scientific leadership and execution of clinical studies, delivering 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 quality data, review emerging clinical data and trends; review and query data; present and discuss relevant data to teams, governance bodies, and stakeholders.
• Conduct data review, analysis, and interpretation of clinical trials data with the GDL, Clinical Safety, and Biostatistics.
• Serve as technical resource for clinical issues raised by internal and external collaborators, investigators, consultants, and contractors.
• Support and assist in the development of publications, abstracts, and presentations.
• May sit on project teams to support clinical development implementation and contribute to milestones, e.g., start-up and delivery of ESOE and POC trials.
• Lead the preparation of clinical protocols and support documents including clinical development plans, INDs, annual reports, CSRs, investigator brochures, SAPs, and regulatory documents.
• Foster a transparent environment that builds partnerships and mutual trust among teams and therapeutic areas.
• Coordinate with ORD and WRD organizations; develop collaborations with internal and external partners across functions (project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, genetics, translational oncology, precision medicine, and development operations).
• Partner with Translational Oncology and Biomarker teams to ensure biomarker plans are integrated for early efficacy signs, POC, and patient stratification.
• Establish and support relationships with external experts, regulators, and investigator networks to integrate current thinking into plans and study designs, manage recruitment and presentation of results.
• Maintain up-to-date knowledge of scientific and clinical literature in relevant therapeutic areas.
• Perform other duties as assigned related to clinical programs and support functional area priorities.

Qualifications

• Required: 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 Oncology, on the sponsor side leading studies.
• Strong understanding of Oncology Drug Development, especially in Early Development.
• Knowledge of clinical procedures, ICH guidelines, GCP, and 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 Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, QA.
• Ability to build consensus and drive 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 when needed.
• Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or similar platforms.

Skills

• Leadership and collaboration across multiple functional areas.
• Scientific writing, data interpretation, and trial design.
• Stakeholder management and cross-functional partnership.

Education

• PhD or PharmD OR MS OR BA/BS with relevant experience as specified above.

Additional Requirements

• 5-10% Travel.
• Hybrid work location.
• Perform complex data analysis as part of job duties.