BioCryst Pharmaceuticals, Inc.

Director

• Lead the conduct and analysis of BioCryst-sponsored clinical studies from Phase I to Phase IV and selected non-clinical studies
• Provide Biometrics support for clinical studies, selected non-clinical studies, and Medical Affairs
• Ensure relevance and adequacy of statistical methods and conformance to regulatory guidelines and Good Clinical Practice
• Contribute to clinical development strategies, development programs, and study design
• Oversee CRO and contract staff performing outsourced operational activities
• Review and approve contracts, work orders, and invoices within delegated authority
• Act as project statistician for an individual project
• Participate in FDA and other regulatory agency meetings as the company’s biostatistical spokesperson
• Define, create, and implement organization-wide processes focused on efficiency and productivity
• Define, monitor, and evaluate relevant performance metrics
• Author and review statistical and biometrics sections of protocols, statistical analysis plans, data management plans, regulatory documents, NDAs, MAAs, regulatory responses, abstracts, and manuscripts
• Ensure accuracy of clinical trial data in public corporate communications, including press releases, presentations, SEC filings, abstracts, and manuscripts
• Monitor the quality audit process for public clinical trial communications
• Communicate technical concepts to technical, regulatory, and broader nontechnical audiences
• Identify, evaluate, and implement new biostatistics and programming processes and technologies
• Develop and align outsourcing strategy with Clinical Development goals
• Perform additional duties as assigned

Executive Director, Biometrics

Content Manager

• Develop and produce content supporting corporate priorities, business milestones, scientific advancements, employee engagement, and corporate reputation objectives
• Translate complex business, scientific, and organizational information into compelling, audience-appropriate communications
• Create and edit emails, intranet content, newsletters, executive communications, presentations, event communications, social media content, and other corporate communications assets
• Ensure consistency of messaging, voice, tone, and brand standards across communications channels
• Lead BioCryst's corporate social media program, including strategy, editorial planning, content creation, publishing, community management, paid promotion, and analytics
• Develop and execute social media campaigns supporting corporate communications objectives, thought leadership, and company milestones
• Monitor social media trends, conversations, risks, and opportunities
• Analyze performance metrics and industry benchmarks to optimize audience engagement and content effectiveness
• Lead content development and publishing for internal communications channels
• Manage Internal Communications intake requests, timelines, approvals, and project status
• Support employee engagement initiatives through strategic communications planning and content creation
• Support media relations activities related to company milestones, announcements, scientific developments, and strategic initiatives
• Monitor media coverage and develop reports, coverage summaries, and leadership updates
• Ensure alignment across external communications, internal messaging, and the corporate narrative
• Manage communications projects from concept through execution with stakeholders across the organization
• Coordinate with external agencies and vendors to develop communications materials and content assets
• Manage vendor budgets, statements of work, invoices, and related administrative processes
• Support MLR/PRC review processes
• Provide communications support for company meetings, employee events, leadership engagements, and other corporate activities
• Perform other duties as assigned

Corporate Communications Content Manager

Compliance

• Work closely with product development core teams and subteams to set and achieve company goals
• Develop and ensure efficient and productive regulatory strategies and submissions
• Assist and collaborate in strategic drug development program implementation
• Coordinate the company’s regulatory program and product development initiatives
• Manage initial global approvals and global post-approval activities for advanced programs with partnering companies
• Manage and support post-approval maintenance activities and lifecycle management submissions in the US and internationally
• Support development and early-phase regulatory projects
• Research regulations and guidelines to support regulatory strategies and regional requirements
• Compile, prepare, and submit IND, BLA/NDA, and additional US regulatory filings
• Serve as Global Regulatory Lead for defined projects and deliverables, including leading workstreams and attending clinical study team meetings
• Track regulatory submissions and changes in regulatory strategies
• Support coordination and preparation of Health Authority meetings
• Review, revise, and draft Standard Operational Procedures
• Manage regulatory timelines and communicate timeline or content risks
• Maintain current knowledge of FDA regulations and guidance regarding INDs and BLAs/NDAs
• Perform other duties as assigned

Associate Director, Regulatory Affairs Strategy

• Develop a vision and strategy for BioCryst’s statistical programming group
• Oversee statistical programming activities for all BioCryst clinical trials, including in-house and outsourced activities
• Lead analyses for regulatory submissions, safety review, scientific publications, and medical affairs
• Manage statistical programmers and ensure strong technical capabilities for complex algorithms and regulatory submission packages
• Define software and systems needs for the Biometrics and Data Science group in partnership with Information Technology
• Keep abreast of industry best practices and standards
• Participate in capacity planning and departmental growth
• Ensure statistical programming leadership and consistent support for all clinical study teams
• Ensure completeness, accuracy, and timeliness of statistical programming for clinical development activities and selected nonclinical studies
• Oversee outsourced statistical programming and meet regularly with CRO counterparts
• Review eCRFs, annotated CRFs, data management plans, edit check specifications, and statistical analysis plans
• Ensure accurate programming of tables, listings, and figures
• Collaborate with data management on regulatory guideline and Good Clinical Practice conformance
• Provide specialty SAS programming and customized line listings for clinical data review
• Provide training and support on internal data review tools
• Select, direct, and supervise CRO/contract staff
• Maintain study documentation according to SOPs and audit standards
• Define, create, and implement organization-wide processes focused on efficiency and productivity
• Author SOPs related to statistical programming
• Monitor and evaluate performance metrics
• Communicate technical concepts to technical, regulatory, and broader nontechnical audiences
• Perform other duties as assigned

Executive Director, Statistical Programming

Vice President

• Ensure relevance, adequacy and accuracy of state-of-the-art statistical methods in BioCryst-sponsored clinical development activities and selected nonclinical studies
• Oversee statistical activities for regulatory submissions, including NDA/BLAs
• Ensure clinical data processing conforms to regulatory guidelines and Good Clinical Practice
• Contribute to clinical development strategies, including development program and study design
• Lead and manage junior biostatistics staff
• Select, direct and supervise CRO and contract staff performing outsourced operational activities
• Use SAS, EAST and R for ad hoc data analyses and sample-size work
• Participate in clinical development and product management teams
• Represent the company on biostatistical topics at FDA and other regulatory agency meetings
• Define, create and implement organization-wide processes focused on efficiency and productivity
• Define, monitor and evaluate relevant performance metrics
• Author and review critical product-development documents, including protocols, statistical analysis plans, data management plans, regulatory briefing documents, NDAs, MAAs, regulatory responses, abstracts and manuscripts
• Ensure accuracy of clinical-trial data in public corporate communications and monitor their quality-audit process
• Communicate technical concepts rigorously to technical, regulatory and nontechnical audiences

VP, Biostatistics

• Oversee BioCryst’s clinical and commercial manufacturing, supply and distribution, logistics/import/export, and Rapivab® commercial business
• Build and lead the clinical and commercial manufacturing, supply and distribution organization
• Ensure uninterrupted supply of clinical and commercial products within forecast and budget
• Strategically guide MSAT activities, including technology transfers, process optimizations, process validations, and technical support for external manufacturing
• Plan and implement procurement, inventory control, production-material planning, quality control, distribution, and logistics activities
• Provide strategic oversight of raw materials, API/drug product, and primary/secondary packaging operations
• Lead the Sales & Operations process for all commercial products and maintain acceptable inventory levels
• Partner with Procurement on materials, services, CMO/3PL agreements, supply-chain services, laboratory/testing services, and distribution contracts
• Own global manufacturing, supply, and distribution risk management
• Collaborate with Finance, Clinical Operations, R&D, Commercial, Quality, Regulatory, and Supply Chain teams
• Manage the Rapivab® commercial business, including US and Australian sales, API sales to strategic partners, and US stockpile agreements
• Provide technical oversight and decision-making for critical manufacturing, supply, and distribution issues
• Support launch planning and regional commercialization/distribution after regulatory approval

SVP, Global Manufacturing, Supply

• Provide scientific and operational leadership for analytical development across biologics programs from early development through late stage and commercialization, primarily at external partners
• Lead analytical strategies for potency, impurities, and other release assays supporting biologics development, clinical supply, late-stage development, and commercialization readiness
• Interpret and apply product quality data to define CQAs, QTPPs, control strategies, and characterization packages supporting regulatory submissions and process changes
• Lead analytical method development, qualification, and testing activities at CDMOs and contract test laboratories
• Author and review analytical reports, technical summaries, and other product development documentation
• Author and review analytical sections of CMC regulatory filings and communicate analytical risks, timelines, and data interpretations
• Build and maintain relationships with CDMO and CTL partners, applying metrics to manage risk, prioritize work, and drive continuous improvement
• Stay current with evolving CMC and global regulatory strategies for biologics and small-molecule programs
• Provide mentorship, coaching, and leadership to internal and matrixed teams
• Partner with QC and Quality stakeholders on method validations, method transfer, reference material qualification, deviation and OOS/OOT investigations, CAPA activities, and lifecycle management
• Perform other duties as assigned

Associate Director, Analytical Development

Manager

• Direct access support between consented patients and relevant stakeholders, including pharmacies, MDOs, and support organizations
• Oversee quality-control efforts relating to pharmacy interfaces with payers
• Direct and coordinate onboarding of new consented patients
• Manage patient status changes in the Patient Services CRM and follow up with internal stakeholders and pharmacy
• Enforce Patient Support Program business rules
• Manage and communicate reimbursement-related information to consented patients and MDOs
• Control information flow and communication touch-points with consented patients
• Support adherence efforts
• Collaborate with Market Access on regional reimbursement patient educational events
• Create and manage comprehensive product access and patient support plans
• Lead cross-functional execution activities and weekly alignment meetings
• Collaborate with Patient Advocacy and patient organizations to support patients
• Develop and facilitate training programs for contracted partners or vendors
• Collaborate with Marketing and commercial functions to report compliant insights and findings
• Adhere to corporate compliance policies and procedures, including handling PHI
• Represent BioCryst at local, regional, and national conferences
• Perform other duties as assigned

Patient Support Manager

Sales

• Compliantly market BioCryst products to customers in the Los Angeles, California area
• Cover the territory from Los Angeles to Las Vegas, Nevada
• Conduct effective customer conversations using selling techniques and marketing strategies to create and expand demand for promoted brands
• Develop and expand understanding of key customers
• Create, maintain, and update an active customer database
• Develop strategies to effectively use marketing materials and programs
• Manage key accounts
• Develop business plans with resource allocations linked to business results
• Build and foster relationships with key decision makers and opinion leaders
• Arrange and coordinate compliant promotional programs
• Conduct field activities including lunch-and-learns, customer in-services, and other customer interactions
• Complete expense reports and administrative reports accurately and promptly
• Report call information in a timely manner
• Attend training programs, conventions, and symposia as requested
• Demonstrate accountability, urgency, and commitment to sales objectives
• Collaborate with internal and external stakeholders and share best practices
• Adhere to company compliance guidelines, policies, and procedures
• Perform other duties as assigned

Sales – Rare Disease Specialist

Medical Director

• 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

Director, Clinical Development Sciences

Data Analyst

• Manage analytics activities supporting a data-driven culture within BioCryst
• Develop and apply analytic methodologies to deepen insights and inform commercial business decisions
• Support BioCryst’s first commercial product launch of ORLADEYO and other rare disease pipeline products
• Integrate data, analytical methods, and insights across Advanced Analytics, Market Insights, and Strategic Operations
• Lead implementation and execution of commercial sales incentive plans for the U.S. and Canada
• Analyze sales, marketing, market access, patient services, and medical affairs data to identify patterns, trends, root causes, opportunities, and threats
• Translate complex analytical findings into concise, actionable recommendations
• Serve as an internal consultant to Commercial, Medical Affairs, and other departments
• Develop, monitor, and maintain business analytics tools, reports, dashboards, and metrics
• Manage access and updates to commercial reports, dashboards, and metrics
• Establish and monitor KPIs with cross-functional partners
• Partner with Data Operations on data mining, exploration, modeling, model deployment, and model assessment
• Ensure a comprehensive and accurate commercial data source of truth
• Refine commercial data and system needs and drive program execution through results delivery
• Ensure accuracy and completeness of data and deliverables
• Perform other duties as assigned