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.
About the role
- Director, Clinical Development Scientist overseeing high complexity clinical trials in biopharmaceuticals. Ensuring adherence to protocols and excellence in clinical development with a focus on patient well-being.
Responsibilities
- 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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