Clinical Development Scientist providing scientific oversight and leading clinical deliverables for trials in Internal Medicine. Responsible for improving processes and mentoring others in the biopharmaceutical field.
Responsibilities
Independently leads clinical execution of one or more studies; accountable for program level clinical deliverables
Provides input to the protocol design document; leads development of the protocol, including protocol amendments
Represents the study team in internal protocol review governance submissions and interactions
Ensures development of Study Informed Consent Documents
Provides clinical guidance to the development of the Statistical Analysis Plan
Sets the clinical data review strategy and leads the team in the review of emerging clinical data and trends
Develops site selection criteria
Serves as the primary clinical point of contact with investigators and study team
Ensures TMF compliance for clinical documents
Leads the adoption and implementation of continuous improvement activities
Requirements
Science degree (PhD, PharmD, or equivalent) with at least 7 years, or MA/MS with at least 10 years, or BA/BS with at least 12 years of Clinical Research experience in a similar role in the biopharmaceutical industry
Clinical research experience in the biopharmaceutical industry in study design, start-up, conduct, and close-out, including regulatory submissions and inspections
Scientific productivity via publications, posters, abstracts and/or presentations
Extensive knowledge of clinical development, global and regional regulation, and ICH/GCP
Clinical, administrative, and project management capabilities
Effective verbal and written communication skills
Experience launching, managing, and training clinical development teams
Track record of achievement in pharmaceutical development
Understanding of recent developments in principal disease areas
Ability to set priorities and manage cross-functional teams and complex projects
Benefits
401(k) plan with Pfizer Matching Contributions and 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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