Director, Toxicology, Non-Clinical Development

COMPANY:

At BioCryst, we are passionate about advancing novel therapeutics for patients with rare and serious diseases. Our structure-guided drug design process leads us to the discovery and development of novel small-molecule drugs. We integrate traditional biology and medicinal chemistry along with a wide array of advanced technologies to understand the three-dimensional structures of active sites of target enzymes. Our scientists then design molecular structures to create bespoke drugs for patients. We focus on therapeutic areas with either no available treatments or large unmet patient needs. BioCryst’s US headquarters are located in Durham, North Carolina, our European headquarters in Dublin, Ireland and our Discovery Center of Excellence in Birmingham, Alabama. 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 the Company’s website at www.biocryst.com.

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. #LI-Remote

 

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Responsibility extends from first concept to regulatory filing of completed studies.
• Accountable for non-clinical 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 non-clinical studies.
• Accountable for oversight and corporate approval of GLP non-clinical research documents including for example non-clinical study synopses, protocols, analysis plans, and study reports.
• May represent the company as non-clinical safety representative at meetings with regulatory bodies.
• Responsible for validity, accuracy, relevance and completeness of scientific content in non-GLP and GLP non-clinical research and regulatory documents.
• Responsible for original writing, editing and review of non-clinical 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 non-clinical research.
• Responsible for oversight of the conduct of non-clinical studies• Responsible for proposing and managing budgets.
• Accountable for corporate strategic relationship development with non-clinical study vendors.
• Accountable for non-clinical strategic and tactical advice to product teams.
• Contributes to the development of global regulatory approval strategies.
• Participates or leads in development of non-clinical publication strategies, writing and editing of draft presentations and manuscripts, and interactions with external non-clinical 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.
• DABT preferred but not essential.
• Demonstrated drug development experience within the pharmaceutical or biotechnology industry in non-clinical toxicology, including program design, study protocol development and study execution, minimum 8 years preferred.
• Experienced with non-clinical 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 non-clinical drug development.
• In depth understanding of the drug development process and intimate understanding of non-clinical development.
• 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.
• Roll-up-the-sleeves attitude.
• Ability to understand, influence, collaborate, and lead in a diverse team-based organization.
• Competence with