JOB SUMMARY:

The Principal Clinical Pharmacologist (Contractor) 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 using Gastroplus.
• 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 parameters, and PK-PD modeling.
• Strong quantitative skills, including solid familiarity with statistical concepts.
• Contribute to the production and authoring of scientific documents with full attention to accuracy and consistency.
• Demonstrated ability to work effectively in a matrixed, team environment, manage multiple priorities and exercise sound judgment.
• Able to create a positive work environment.
• Ability to negotiate conflict and maintain constructive working relationships with people at all levels of the organization.
• Able to manage vendors but remain "hands on" to drive project deliverables.
• Ability to use standard software packages, e.g., Excel, Word, Power Point.

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.