The Executive Director, Nonclinical Development will provide scientific leadership, strategic planning and actively contribute to the drug development process from discovery through marketed products. Will provide leadership of the nonclinical process through designing and implementing nonclinical strategies for successful development of the company’s lead molecules across all stages of development. Responsible for the leadership and guidance of the nonclinical department activities with focus on in vitro and in vivo pharmacology, biomarkers, drug metabolism and pharmacokinetics (DMPK), bioanalytical assay validation and conduct. Will provide strategic guidance and scientific quality and integrity in the design, planning, initiation, and successful completion of nonclinical studies required for a new or marketed drug for all phases of development. The Executive Director, Nonclinical Development will also provide oversight and review of the required regulatory documentation in support of IND, NDA, PMDA, and other submissions. The ability to execute and lead sound science-based nonclinical discovery and development strategies to support clinical development is a crucial part of this position. Responsible for supporting interactions with other key groups within BioCryst, such as Discovery Biology, Medicinal Chemistry, Regulatory, and Clinical Pharmacology. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Lead and provide guidance to the nonclinical group in all matters related to in vitro and in vivo pharmacology, biomarkers, drug disposition studies and bioanalysis related to compounds in discovery and all stages of drug development.
• Provide scientific guidance to senior management on key issues related to nonclinical discovery and development through informal discussions and formal meetings including Program Leadership Teams, Development Review Group, Science Committees and Board Meetings.
• Critically evaluate and interpret results of scientific studies and contribute to appropriate sections of INDs, NDAs, IBs and other regulatory documents.
• Represent BioCryst at national and international regulatory meetings.
• Design and prepare summaries pertaining to nonclinical studies to support investigational new drug and new drug application programs.
• Assist in resolving nonclinical issues through the establishment of novel protocols to solve experimental questions.
• Direct and give design input for internal/external drug disposition and pharmacology studies.
• Serve as key point person to coordinate early activities for a successful transition of nonclinical research to clinical settings.
• Provide nonclinical updates through presentations to project teams and management as requested.
• Coordinate authoring of preclinical documents – e.g., nonclinical PK summaries, nonclinical safety summaries, and nonclinical pharmacology summaries used in regulatory submissions.
• Manage nonclinical development staff including external vendors.
• Prepare budget proposals and support the management of department expenses accordingly.
• Assist in the review of vendor contracts and legal agreements as appropriate.

EXPERIENCE & QUALIFICATIONS:

• Ph.D. or M.S. in biological science with emphasis in toxicology and/or pharmacology is preferred.
• A minimum of 15 years’ experience of pharmaceutical/biotech industry experience in nonclinical pharmacology, as well as drug discovery and development are required.
• Experience in the writing and review of regulatory documents (both IND and NDA/BLA) and prior experience with US and international regulatory agency interactions.
• Ability to build productive cross-functional collaborations both internally and externally is essential.
• Sustained record of achievement in leading pharmacology and biomarker research supporting drug development candidates is required.
• Demonstrated strong decision making and complex data analysis and interpretation relating to drug development.
• Strong communication, organizational and interpersonal skills to work within a matrix setting.

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.