Senior Director, small molecule leading analytical development and QC for biopharmaceutical company Insmed. Driving strategies and ensuring regulatory compliance for developing small molecule programs.
About the role
- Director leading clinical execution and managing high-complexity studies at Pfizer. Ensuring scientific integrity and developing protocols for clinical data interpretation.
Responsibilities
- Ensures scientific integrity and participant safety in clinical trials
- Designs and executes high-quality studies
- Maintains compliance and manages risks and emerging clinical issues
- Supports interpretation and communication of clinical data
- Leads clinical execution of one or more studies of medium - high complexity
- Contributes to continuous improvement / process enhancement activities
- Provides clinical input to support development of the protocol design document
- Authors and manages approval of Informed Consent Documents (ICDs)
- Responsible for providing clinical input to statistical analysis plan (SAP)
- Reviews and approves final document inputs to Risk Management and Safety Review Plan
- Reviews patient level and cumulative data per the data review plan
Requirements
- Advanced degree or professional certification in a health care related, scientific or technical discipline required
- Years of experience in biopharmaceutical industry in clinical research and development: BA/BS with 8+ years of experience, MBA/MS with 7+ years of experience, PhD/PharmD with 5+ years of experience
- 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
- Excellent verbal and written communication skills in English
- Demonstrated experience establishing, managing, and training teams in clinical development
- Ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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 including medical, prescription drug, dental and vision coverage
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