Director, Clinical Development Sciences

BioCryst Pharmaceuticals, Inc.

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

Posted 9/17/2026full-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 teams and fostering relationships with stakeholders in the pharmaceutical development process.

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 Trial DesignProtocol DevelopmentStatistical AnalysisData ReviewGCPData Collection ToolsClinical Study ReportsRisk ManagementScientific ValidityData Quality

Soft Skills

LeadershipInterpersonal SkillsEffective CommunicationRelationship ManagementDecision-Making

Certifications & Qualifications

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

Industry Keywords

Pharmaceutical DevelopmentClinical DevelopmentRegulatory ProcessRare Disease Drug DevelopmentCross-Functional TeamsGlobal Marketing ApplicationsFDAEMAScholarship and PublicationClinical Operations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead delivery of high-quality data from multiple sources while supporting global development programs for one or more product candidates across all study phases
Lead development program design, conduct, oversight, protocol design, execution, analysis, and reporting
Lead program- and compound-level development activities and multidisciplinary clinical development teams
Contribute to clinical strategy discussions and create and review clinical documents supporting regulatory submissions
Represent Clinical Development Sciences in integrated development teams to uphold scientific, ethical, and regulatory standards and support worldwide registration submissions
Lead multidisciplinary clinical development teams, including proactive risk identification and management, consistency, data quality, and scientific validity
Review medical and scientific elements of protocols, IBs, IND, MAA/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 for critical study documentation, including statistical analysis plans
Support optimal study execution and data collection with clinical operations, data management, and statistics
Train CRAs; select laboratory assessments for safety and pharmacodynamics; and provide input into tables, listings, and figures
Serve as SME for global marketing-application regulatory questions and support responses to CTA questions outside the US
Collaborate with study teams, data management, biostatistics, regulatory, and other functional 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, investigator meetings, study-data sessions, and advisory boards
Provide leadership and oversight to clinical development staff and study-level scientists
Set goals and evaluate performance for direct reports; support career-path clarity, training plans, and leadership development
Perform other duties as assigned

Requirements

What you’ll need

Bachelor’s degree required
A minimum of 10 years of pharmaceutical development experience, including at least 3 years in a Sponsor role and 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, make high-level decisions, and communicate effectively at senior management level and externally
Ability to communicate information appropriately for target audiences, including patients, regulatory agencies, FDA, EMA, investigators, and external/key opinion leader advisory panels
Advanced scientific degree (MD/PhD/PharmD) strongly preferred

Benefits

Comp & perks

Equal employment opportunity commitment
Employment protections for veterans and individuals with disabilities
Federal, state, and local employment-law compliance