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BioCryst Pharmaceuticals, Inc. · 1 day ago

Principal Clinical Pharmacologist (Contract)

United States

Full-time, Contract

Remote

Senior Level, Lead/Staff

5+ years exp

BioCryst Pharmaceuticals, Inc. is seeking a Principal Clinical Pharmacologist to provide leadership and support to the clinical pharmacology team. This role involves overseeing Phase I studies, coordinating communication with investigators and regulatory authorities, and engaging in model-based analyses to support drug development.

BiotechnologyClinical TrialsTherapeutics

H1B Sponsor Likely

Responsibilities

Responsible for scientific quality of clinical pharmacology studies: design, implementation, analysis, interpretation, reporting and regulatory submission

Plans clinical pharmacology strategy and supports overall development strategy for assigned program(s)

Represents clinical pharmacology in program- and study-level forums, providing bold and innovative strategic input

Integrates clinical pharmacology knowledge with a broad understanding of and collaboration with related disciplines such as clinical, statistics, regulatory, nonclinical ADME, and toxicology to support and impact development decisions. Partners with relevant stakeholders from discovery through commercialization

Performs and/or supports appropriate clinical pharmacology data analyses (e.g., PK, PD, PKPD, PPK, PBPK, and/or QSP) for assigned studies and program(s)

Key contributor (author/and or reviewer, as required) to 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 validity, accuracy, relevance, and completeness of medical and scientific content in clinical research and regulatory documents, with adherence to timelines and budgets

Collaboration with internal stakeholders, vendors, and/or consultants in support of model-based analyses (e.g., PPK, PKPD, PBPK, QSP)

Effectively communicate clinical pharmacology concepts to diverse audiences, including program strategy, rationale for study designs, and results from studies

Maintains and establishes relationships and agreements with contract vendors

Shares clinical pharmacology and drug development knowledge within the clinical pharmacology team in support of mutual continued professional development

Supports representation of BioCryst clinical pharmacology program(s) as required to government agencies, key opinion leaders, and scientific meetings

Contributes to scientific publications for assigned program(s)

Incorporates relevant recent advances in the field into clinical research

All other duties as assigned

Qualification

Clinical pharmacology expertisePK/PD analysisRegulatory submission experienceModel-based analysesPhoenix WinNonlinData analysis with RScientific writingVendor managementMicrosoft Office proficiencyCommunicationProblem-solving skillsTeam collaboration

Required

PhD or PharmD degree with emphasis in clinical pharmacology, pharmacokinetics or a related scientific discipline. Other relevant combinations of degrees and experience may also be considered

5+ 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 clinical pharmacology 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)

Deep understanding of clinical pharmacology concepts with demonstrated expertise in PK and PD analyses

Demonstrated track record of scientific rigor in experimental design, study conduct, analysis, interpretation and communication of results to diverse stakeholders

Ability to critically analyze problems and provide creative solutions

Excellent written and oral communication skills and ability to convey complex technical information clearly to diverse audiences

Strong quantitative and data analysis skills, including solid familiarity with statistical concepts

Strong scientific writing skills, with attention to accuracy and consistency in scientific and regulatory documents

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 conflicts 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

Proficiency with standard software packages (e.g. Microsoft Office suite)

Preferred

Experience with PK analysis in commonly used software required (Phoenix WinNonlin experience is preferred)

Direct experience with model-based analyses (e.g., PPK, PKPD, PBPK, and/or QSP) and associated software is a plus

Proficiency in data analysis and visualization via R or other coding language(s) is a plus

Rare disease experience is a plus

Company

BioCryst Pharmaceuticals, Inc.

BioCryst Pharmaceuticals is a global biotechnology company with a deep commitment to improving the lives of people living with hereditary angioedema (HAE) and other rare diseases.

Founded in 1986

Durham, North Carolina, USA

501-1000 employees

http://www.biocryst.com

H1B Sponsorship

BioCryst Pharmaceuticals, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2021 (1)