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.
The VP, Non-Clinical Development will provide scientific leadership, strategic planning and actively contribute to the drug development process from late-stage discovery through marketed products. Accountable for leading the non-clinical development process through designing and implementing non-clinical strategies for successful development of the company's lead molecules across all stages of development. Responsible for the leadership and guidance of the non-clinical department activities which comprise toxicology, drug metabolism and pharmacokinetics (DMPK), bioanalytical assay validation and conduct, and biomarkers. Will be responsible for strategic guidance and scientific quality and integrity in the design, planning, initiation, and successful completion of all non-clinical studies required for a new or marketed drug for all phases of development. The VP, Non-Clinical Development will also be responsible for 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 non-clinical development strategies to support clinical development is a crucial part of this position. Responsible for establishing and culturing interactions with other key groups within BioCryst, such as Discovery, Regulatory, and Clinical Pharmacology.
ESSENTIAL DUTIES & RESPONSIBILITIES:
* Lead and provide guidance to the non-clinical group in all matters related to safety assessment, drug disposition studies and bioanalysis related to compounds in all stages of drug development.
* Provide scientific guidance to senior management on key issues related to non-clinical 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 toxicology and nonclinical studies to support investigational new drug and new drug application programs.
* Assist in resolving nonclinical safety issues through the establishment of novel protocols to solve experimental questions.
* Direct and give design input for internal/external toxicology, 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 and toxicological updates through presentations to project teams and management as requested.
* Coordinate authoring of other preclinical documents - e.g., non-clinical PK summaries and nonclinical pharmacology summaries used in regulatory submissions.
* Manage non-clinical development staff including external vendors.
* Prepare budget proposals and manage 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 preferred.
* A minimum of 15 years' experience of pharmaceutical/biotech industry experience in nonclinical safety assessment and nonclinical drug development required.
* Professional membership (e.g, SOT or ACT) is desirable.
* 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 toxicology research programs supporting safety assessment of 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.