Senior Director managing execution of clinical trial programs to advance gene therapy. Leading clinical operations, ensuring strategic execution, and mentoring clinical teams across multiple clinical programs.
PF
Hybrid Oncology Early Stage Clinical Development Scientist – Director, Non MD
Posted 2 months ago
About the role
- Lead clinical development for early-stage oncology therapies at Pfizer, involving protocol development and study execution. Collaborate with teams to ensure timely study delivery and quality data analysis.
Responsibilities
- 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
- Work closely 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)
- Develop clinical protocol and participate as an individual contributor on clinical teams with Pfizer development operations and project team, to meet enrollment and study delivery timelines
- Work with other functional disciples to ensure the full scope and remit of Oncology Early Stage Development (OESD) is represented as needed within clinical study teams
- Conduct data review, analysis and interpretation of clinical trials data with 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
Requirements
- Relevant PhD or PharmD and a minimum of 5 years of experience in a similar role in industry/CRO, OR MS and a minimum of 7 years of experience in a similar role in industry/CRO, OR BA/BS and a minimum of 10 years of experience in a similar role in industry/CRO
- Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
- Experience in or strong understanding of Oncology Drug Development especially in Early Development
- Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations
- Strong scientific writing skills and communication skills (written and verbal)
- Clinical document writing experience (e.g., protocol, ICD, IB, IND), as well as understanding complex data analysis
- Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations
- Experience working with and solid understanding of related disciplines, e.g., Clinical Operations, Data Management, Safety, Biostatistics, Regulatory, Study Management, Pre-Clinical, Pharmacology, Quality Assurance
- Experience building consensus and driving change across all levels of the organization including senior management
- Data listing review experience
- Experience working collaboratively in a fast-paced, team-based matrix environment as well as working independently when appropriate
- Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or other similar platform
Benefits
- 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution
- paid vacation
- holiday and personal days
- paid caregiver/parental and medical leave
- health benefits to include medical, prescription drug, dental and vision coverage
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