Principal Clinical Pharmacologist

About the job

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.

Essential Duties & 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 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.

Experience & Qualifications

• 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). Rare disease experience is a plus.
• 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.
• 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.
• 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).