Sr. Toxicologist

COMPANY:

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.

JOB SUMMARY:

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. The successful candidate will have a few years of direct experience as a Study Director at a Contract Research Organization with a focus in Toxicology studies as they apply to pharmaceutical development and will use this experience to provide oversight of BioCryst studies while liaising internally with BioCryst scientists to ensure seamless communication enabling the streamlining of scientific operations. 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Collaborate with nonclinical program leads and other subject matter experts to design nonclinical studies in alignment with program needs and regulatory requirements.
• 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.
• Work closely with the CRO staff to ensure data quality and robust interpretation therein
• Lead the internal review of study reports, CTD tables, and SEND datasets ensuring regulatory submission readiness
• Communicate study findings with clarity to a mixed audience
• 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
• Schedule and participate in department and study-related meetings, as required.
• General operational support including document processing, maintaining file systems for accuracy and completeness, invoice review and approval

EXPERIENCE & QUALIFICATIONS:

• 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.
• Excellent written and oral communication, interpersonal, and organizational skills.
• 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.
• Ability to align activities with company objectives.
• Willingness to travel to Birmingham AL, and Durham, NC for face-to-face meetings as necessary and to CROs for site visits.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing 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. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity 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.