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.
Accountable for assisting with the toxicology strategy for successful development of the company's small molecule and biologics 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. Experience in discovery toxicology preferred. #LI-Remote
ESSENTIAL DUTIES & RESPONSIBILITIES:
* Accountable for non-clinical toxicology and safety pharmacology activities.
* Manage out-sourced activities, including proposal generation and approval, vendor selection, protocol generation, study conduct and monitoring, report review and approval.
* Assist with selection and management of qualified vendors for non-clinical studies.
* Contributes to oversight and corporate approval of 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.
* Attend appropriate scientific meetings and stays up to date with relevant scientific literature to maintain expertise.
* Responsible for proposing and managing budgets.
* Contributes to 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:
* Masters or PhD degree in toxicology or pharmacology with relevant postdoctoral experience.
* DABT preferred but not essential.
* Demonstrated experience in conducting GLP toxicology studies relevant to drug development. 5-10 years of experience preferred.
* Good understanding of development programs for oral and parenteral therapeutics.
* Experience in conduct of screening assays (e.g., mini-AMES or mini-hERG) within Discovery Toxicology highly preferred.
* 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 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.