Executive Director, Translational Modeling

COMPANY:

At BioCryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and 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, our European headquarters is in Dublin, Ireland 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:

The Executive Director, Translational Modeling in Nonclinical Development will provide scientific leadership, strategic planning and actively contribute to the drug development process from discovery through early development and beyond. Will provide leadership on the designing and implementing of translational PK, PBPK, PK/PD and QSP data analyses strategies for successful development of the company’s lead molecules. The Executive Director, Translational Modeling will also provide oversight and review of the required regulatory documentation in support of IND, NDA, BLA, and other submissions. The ability to execute and lead sound science-based translational modeling (nonclinical discovery and development) strategies to support discovery and clinical development is a crucial part of this position. Responsible for supporting interactions with other key groups within BioCryst, such as DMPK, Bioanalytical and Biomarker, Toxicology, Discovery Biology, Medicinal Chemistry, Regulatory, and Clinical Pharmacology. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Overall responsibility for direction, oversight, and development of translational PK, PD and PK-PD data analyses strategies in the Nonclinical Development department. Responsible for scientific quality of nonclinical studies: design, implementation, analysis, interpretation, reporting and regulatory submission.
• Integrates nonclinical and clinical knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, toxicology to support and impact development decisions. Partners with relevant stakeholders from discovery through commercialization.
• Ensures appropriate PK, PBPK, PK/PD and QSP data analyses (including PK, PK-PD modeling and simulation) are conducted for each discovery and early development program.
• Key contributor (author/and or reviewer, as required) to high quality nonclinical PK-PD plans and content for global regulatory documents including investigator’s brochures, briefing documents, IND applications/annual reports, as well as responses to regulatory queries.
• Ensures adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from nonclinical discovery and early development studies and programs.
• Oversees nonclinical and pharmacometrics consultants, as well as maintains and establishes relationships and agreements with contract vendors.
• Presents data at scientific meetings, and authors/reviews manuscripts for submission to peer-reviewed journals.

 

EXPERIENCE & QUALIFICATIONS:

• PhD or PharmD degree with emphasis in clinical pharmacology, pharmacokinetics, DMPK, or a related scientific discipline. Experience in Pharmacometrics is a plus.
• 10+ years of PK, PBPK, PK/PD and QSP data analyses experience with demonstrated accomplishments in experimental design, regulatory considerations and execution of nonclinical and/or clinical PK/PD programs.
• Must have experience interaction on cross-functional teams, preferably working on compounds in multiple therapeutic areas in all phases of development (preclinical through submission).
• Excellent written and oral communication skills and ability to convey complex technical information clearly, as well as confidence and ability to present to and influence senior leaders.
• Ability to critically analyze problems and provide creative solutions.
• Scientific rigor in experimental design, study conduct, analysis, inte