Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact
Provides clinical input to support development of the protocol design document (PDD)
Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement
Partners with/supports the Global Development Lead in governance review and approval process
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters
Provides clinical input to the development of data collection tools
Responsible for providing clinical input to SAP, TLFs and BDR
Requirements
Advanced degree or professional certification in a health care related, scientific or technical discipline required
5+ years of experience and track record of success in biopharmaceutical industry in clinical research and development
Clinical research experience in phase 3/pivotal space
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
Demonstrated clinical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English
Demonstrated experience establishing, managing, and training teams in clinical development
Benefits
401(k) plan with Pfizer Matching Contributions
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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