Director, Clinical Development Sciences

BioCryst Pharmaceuticals, Inc.

. Lead delivery of high-quality data from multiple sources while supporting management of global development programs for one or more product candidates in all study phases .

Posted 11/5/2026full-timeRemote • North Carolina • United StatesLeadWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial design, execution, and regulatory submissions, with a strong focus on data quality and scientific validity. Proven leadership in managing multidisciplinary clinical development teams and fostering collaboration across functional areas.

Highest-signal resume keywords

Clinical Trial DesignRegulatory SubmissionsLeadership in Clinical DevelopmentStatistical AnalysisPharmaceutical Development Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical DevelopmentProtocol DesignData AnalysisGCPStatistical Analysis PlansRare Disease Drug DevelopmentScientific ReviewData Collection ToolsExecution of Clinical StudiesManagement of Cross-Functional Teams

Soft Skills

Strong LeadershipInterpersonal SkillsEffective CommunicationRelationship ManagementDecision-Making

Certifications & Qualifications

Bachelor's DegreeAdvanced Scientific Degree (MD/PhD/PharmD)

Industry Keywords

Pharmaceutical DevelopmentClinical ResearchRegulatory ProcessFDAEuropean Medicines Agency (EMA)Scholarship and PublicationClinical Study ReportsInvestigator MeetingsKOL Advisory PanelsGlobal Marketing Applications

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead delivery of high-quality data from multiple sources while supporting management of global development programs for one or more product candidates in all study phases
Lead development program design, conduct, and oversight, including protocol design, execution, analysis, and reporting
Lead program- and compound-level development activities and multidisciplinary clinical development teams
Contribute to clinical strategy discussions and creation and review of clinical documents supporting regulatory submissions
Represent Clinical Development Sciences in integrated development teams
Lead multidisciplinary clinical development teams, including proactive risk identification and management, consistency across programs, data quality, and scientific validity
Own or scientifically review medical and scientific elements of clinical research and regulatory documents, including protocols, IBs, IND, MAA or NDA modules, PIP/PPSR documents, and clinical study reports
Serve as subject matter expert for assigned clinical development programs and lead trial/program design, data collection tools, data review, and data analysis
Provide input and oversight into critical study-level documentation, including statistical analysis plans
Support optimal study execution and data collection with clinical operations, data management, and statistics
Train CRAs and provide input into laboratory assessments and tables, listings, and figures
Serve as SME for regulatory questions on global marketing applications and support responses to regulatory questions on CTAs outside the US
Establish and maintain communication and collaboration with functional-area peers
Support external dissemination of clinical trial data through publication committees, abstracts, posters, and manuscripts
Present to and interact with investigators and thought leaders
Conduct or oversee scientific training, including SIVs, Investigator Meetings, study data, clinical development, and medical advisory boards
Provide leadership and oversight to clinical development staff and study-level scientists
Set goals and evaluate staff performance; support career-path clarity, training plans, and leadership development
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree required
Advanced scientific degree (MD/PhD/PharmD) strongly preferred
Minimum of 10 years of pharmaceutical development experience
At least 3 years in a Sponsor role
Broad experience in clinical development or an equivalent combination of education and experience
Expertise in clinical trial and program design, conduct, interpretation of scientific data, GCP, statistical analysis, and management of cross-functional clinical/regulatory teams
Experience in Rare Disease drug development is desirable
Demonstrated track record of scholarship, publication and membership in scholarly societies OR proven track record of successful protocol development, execution, and reporting in industry
Understanding of pharmaceutical business, worldwide drug development and regulatory process
Ability to work independently and manage multiple studies concurrently
Strong leadership and interpersonal skills
Ability to manage and cultivate relationships, recommend/make high-level decisions, and communicate effectively at a senior management level and externally
Ability to clearly communicate information appropriate for target audiences, including presentations to FDA and European Medicines Agency (EMA), investigator meetings, and external/key opinion leader (KOL) advisory panels

Benefits

Comp & perks

Equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics
Commitment to compliance with all federal, state and local law