Director, Toxicology

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:

Accountable for leading the toxicology strategy for successful development of the company’s small molecule and protein therapeutics across all stages of development.  Responsibilities include the design, planning, initiation and successful completion of toxicology studies required for new or marketed drugs for all phases of development.

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Responsibility extends from first concept to regulatory filing of completed studies.
• Accountable for nonclinical toxicology and safety pharmacology activities.
• Manage all aspects of out-sourced activities, including proposal generation and approval, vendor selection, protocol generation, study conduct and monitoring, report review and approval.
• Accountable for selection and management of qualified vendors for nonclinical studies.
• Accountable for oversight and corporate approval of GLP nonclinical research documents including for example nonclinical study synopses, protocols, analysis plans, and study reports.
• May represent the company as nonclinical safety representative at meetings with regulatory bodies.
• Responsible for validity, accuracy, relevance and completeness of scientific content in non-GLP and GLP nonclinical research and regulatory documents.
• Responsible for original writing, editing and review of nonclinical GLP regulatory documents.
• Play a pivotal role in IND candidate selection and all stage gate processes.
• Attend appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise.
• Accountable for incorporating relevant recent advances in the field into nonclinical research.
• Responsible for oversight of the conduct of nonclinical studies
• Responsible for proposing and managing budgets.
• Accountable for corporate strategic relationship development with nonclinical study vendors.
• Accountable for nonclinical strategic and tactical advice to product teams.
• Contributes to the development of global regulatory approval strategies.
• Participates or leads in development of nonclinical publication strategies, writing and editing of draft presentations and manuscripts, and interactions with external nonclinical investigators.
• Responsible for sharing scientific knowledge with the organization during continuing education sessions, at an adapted level of understanding.
• Attends appropriate scientific meetings to maintain awareness of research activities

EXPERIENCE & QUALIFICATIONS:

• PhD degree in toxicology or pharmacology with relevant postdoctoral experience.
• Demonstrated drug development experience within the pharmaceutical or biotechnology industry in nonclinical toxicology, including program design, study protocol development and study execution, minimum 8 years preferred.
• Experienced with nonclinical development programs for protein therapeutics (monoclonal antibodies, fusion proteins) and small molecules.
• Experienced in development programs for oral and parenteral therapeutics.
• Proven experience with virtual drug development as it pertains to nonclinical drug development.
• In depth understanding of the drug development process and intimate understanding of nonclinical development.
• In depth familiarity with ICH, FDA and other regulatory guidance and regulations relevant to nonclinical research.
• Excellent written and oral communication, interpersonal, and organizational skills.
• Initiative in producing high quality work product in a small company environment.
• Roll-up-the-sleeves attitude.
• Ability to understand, influence, collaborate, and lead in a diverse team-based organization.
• Competence with standard office computer software tools.
• Ability to align activities with company objectives.

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.