Compliance Audit Manager conducting research billing audits and managing the Research Billing Compliance program at McKesson. Engage in key audits at oncology practices ensuring ethical and lawful practices.
About the role
- Lead and coordinate early phase clinical studies for novel therapies in Oncology at Pfizer. Collaborate closely with Global Development leads and multiple teams to execute development plans effectively.
Responsibilities
- 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
- Work closely with the Global Development Lead and team to execute early oncology clinical development plans
- Develop clinical protocols and participate in clinical teams to meet enrollment and study timelines
- Collaborate with functional disciplines within oncology early stage development
- Conduct data review, analysis, and interpretation of clinical trials data
- Support the development of publications and presentations
- Establish relationships with external experts and integrate latest clinical thinking into development plans
Requirements
- Relevant 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 of experience, OR BA/BS with a minimum of 10 years
- Clinical Research experience in Phase 1 in Oncology, on the side of the sponsor leading studies
- Strong understanding of Oncology Drug Development especially in Early Development
- Strong knowledge of clinical procedures, ICH guidelines, GCP, and relevant regulations
- Strong scientific writing and communication skills (written and verbal)
- Experience with clinical document writing (e.g., protocol, ICD, IB, IND)
- Track record of scientific productivity through publications, posters, abstracts and/or presentations
- Experience with related disciplines (e.g., Clinical Operations, Safety, Biostatistics)
- Experience building consensus and driving change across all organization levels
- Critical thinking and ability to work collaboratively in a team-based environment
- Experience performing complex data analyses using JReview, SpotFire, SOCs-PRO or similar platform
Benefits
- 401(k) plan with Pfizer Matching Contributions
- Pfizer Retirement Savings Contribution
- Paid vacation
- Holiday and personal days
- Paid caregiver/parental and medical leave
- Health benefits including medical, prescription drug, dental and vision coverage
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