Principal Clinical Pharmacologist

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:

The Principal Clinical Pharmacologist will provide leadership and support to the clinical pharmacology team and assist in coordinating communication from the group to investigators and regulatory authorities. S/He will be a clinical pharmacology expert within the company, primarily responsible for leading studies and projects independently, including design, oversight and evaluation of Phase I studies. In addition, this position will include PBPK modeling activities to support early and late stage drug development. The person in this position works independently for global projects while establishing KOL and regulatory interactions, and interacting with outside vendors as well as regional and global study team members and senior management. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Responsible for scientific quality of clinical pharmacology studies: design, implementation, analysis, interpretation, reporting and regulatory submission.
• Integrates clinical pharmacology 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, PD and PK-PD data analyses are conducted for each study/program.
• Develops PBPK models to support drug development from early to late stage.
• Key contributor (author/and or reviewer, as required) to high quality clinical pharmacology plans and content for global regulatory documents including protocols, investigator’s brochures, briefing documents, IND applications/annual reports, responses to regulatory queries, CSRs, and Clinical Pharmacology and Biopharmaceutics Summary Documents in NDAs/MAAs.
• Ensures adherence to agreed timelines and budgets to insure prompt and accurate execution of deliverables from clinical pharmacology studies and programs.
• Oversees clinical pharmacology and PBPK consultants.
• Maintains and establishes relationships and agreements with contract vendors.
• Supervises, develops and mentors junior level scientists, both direct reports and via matrix structure in clinical pharmacology teams.
• Supports representation of BioCryst clinical pharmacology studies as required to government agencies, key opinion leaders.
• Presents data at scientific meetings.
• Authors/ reviews manuscripts for submission to peer-reviewed journals.
• All other duties as assigned.

 

EXPERIENCE & QUALIFICATIONS:

• PhD or PharmD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline.
• 4+ years of clinical pharmacology experience with demonstrated accomplishments in experimental design, regulatory considerations and clinical execution of clinical PK/PD programs for small and large molecules.
• Must have experience as a Program Lead with significant interaction on cross-functional teams, preferably working on compounds in multiple therapeutic areas in all phases of development (preclinical through submission).
• Must have some experience in PBPK modeling.
• Excellent written and oral communication skills and ability to convey complex technical information clearly.
• Ability to critically analyze problems and provide creative solutions.
• Scientific rigor in experimental design, study conduct, analysis, interpretation and communication of results.
• Ability to effectively communicate pharmacokinetic concepts to diverse audiences, including rationale for study designs.
• Academic track record of achievement as evidenced by publication record.
• Solid understanding of clinical pharmacology and pharmacodynamics, including pharmacokinetics, derivation of PK