Clinical Research Project Manager managing clinical trials involving radiation therapy at the Perelman School of Medicine. Ensuring adherence to protocols and supporting operational activities within the team.
About the role
- Oncology Early Stage Clinical Scientist leading and executing clinical development plans for novel therapies. Collaborating with development team, ensuring high-quality trial execution and managing safety assessments.
Responsibilities
- Work collaboratively with the Global Development Lead (GDL) to establish, lead, coordinate, and execute the early oncology clinical development plan(s) for one or more novel biological or small molecule therapies
- Lead the preparation of clinical protocol and supports other critical documents
- Collaborate with Clinical Operations to ensure timely execution of First-in-Human (FIH) programs through proof-of-concept
- Participate in safety assessment and interpretation of clinical study results
- Regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead
- Support the transition early development clinical programs into late stage development
- Prepare presentations regarding strategy and/or data
- Assist with authoring clinical sections of regulatory documents
Requirements
- PhD/PharmD and 2+ years experience in a clinical scientist type role
- MA/MBA/MS and 5+ years clinical development experience including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
- BA/BS/BSN and 7+ years of experience in clinical development including 2 years of experience in a clinical scientist type role with a proven track record executing oncology development programs to completion or targeted milestone
- Experience in Oncology drug development especially in Early Development
- Familiarity with related disciplines (Biostatistics, Regulatory, Pre-Clinical Pharmacology, Pharmaceutical Sciences)
- Proven scientific writing skills and strong communication skills
- Demonstrated experience with GCP and (the ability to apply Pfizer policies and SOPs)
- 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 independently
- 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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