BioCryst Pharmaceuticals, Inc.

Sr. Toxicologist

US_North Carolina_Remote, USA · Senior

Sponsorship not specifiedDetected 82 days ago

PharmacologyFDA RegulatoryResearchCommunicationPublic SpeakingOrganizational Skills

About the role

We are seeking a highly organized and detail-oriented early-career scientist to join us in a cross-functional role serving as an integral liaison between BioCryst and Contract Research Organizations (CROs) serving predominantly as Study Monitor.
Act as Study Monitor for Toxicology, Pharmacology, and/or Bioanalytical studies conducted at CROs
Serve as liaison with CROs to facilitate study outsourcing including but not limited to timelines, quotes, contracts and issue resolution.

Lead the internal review of study reports, CTD tables, and SEND datasets ensuring regulatory submission readiness
Track and maintain study specific milestones using in-house database in support of quarterly finance updates
Coordinate sample shipments, receipt and transfer of sensitive study samples; maintain Chain of Custody
Maintain and update study outlines
Provide general assistance to BioCryst Scientists during study planning, design, execution and interpretation.
Create or QC various reports, data, data tables, presentations, documents for regulatory submissions (e.g., IND, IB).
Plan, prioritize, and manage a diverse workload with associated responsibilities
General operational support including document processing, maintaining file systems for accuracy and completeness, invoice review and approval
Collaborate with nonclinical program leads and other subject matter experts to design nonclinical studies in alignment with program needs and regulatory requirements.

Ability to align activities with company objectives.
They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified.
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
Schedule and participate in department and study-related meetings, as required.
PhD degree in Toxicology or Pharmacology with demonstrated experience in conducting GLP toxicology studies as a Study Director at a Contract Research Organization (CRO) for at least 3 years (or the equivalent combination of education and experience i.e. MS degree + 5 years' experience).
In depth familiarity with ICH, FDA and other regulatory guidance and regulations relevant to non-clinical research.
Initiative in producing high quality work product in a small company environment.
Ability to understand, influence, collaborate, and lead in a diverse team-based organization.
Willingness to travel to Birmingham AL, and Durham, NC for face-to-face meetings as necessary and to CROs for site visits.

Excellent written and oral communication, interpersonal, and organizational skills.

At BioCryst, we share a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.
We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and injectable protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.
Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries.
We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives.
For more information, please visit our website at www.biocryst.com or follow us on LinkedIn and Instagram.

Employer/Protected Veterans/Individuals with Disabilities
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.
For further information, please review the Know Your Rights notice from the Department of Labor.

This listing is sourced directly from BioCryst Pharmaceuticals, Inc.'s careers page and normalized into a canonical job model.