- Have ultimate responsibility and accountability for clinical pharmacology from first-in human through approval, including post-marketing activities for assigned projects
- Therapeutic optimization and individualization (right dose for right patient) by applying state-of-the-art scientific principles and quantitative framework (e.g. MIDD) to evaluate exposure-response relationships based on knowledge of drug disposition, pharmacology, disease biology, patient population, competitive landscape, background therapy, patient variability in PK and responses, formulation effects, impact of immunogenicity 【職務の内容 / Essential Job Responsibilities】 (Immediately after hiring)
- Representing the department and providing subject matter expertise on cross-functional project teams starting with candidate nomination (pre-initiation of GLP tox) through approval and post marketing
- Leading cross-functional sub-teams necessary by phase of development to achieve Clinical Pharmacology goals
- Providing effective oversight of clinical pharmacology aspects of clinical trials (including study design, interpretation and communication of results)
- Participating in cross-functional discussions and collaborating with individuals across disciplines; mentoring junior members
- Authoring/reviewing clinical protocols, analysis plans, study reports and regulatory submissions
- Developing high quality clinical pharmacology plans and content for global regulatory submissions, including INDs, IBs, NDAs, MAAs, diversity and pediatric plans
- Presentation of clinical pharmacology aspects of the global clinical development program at internal and external meetings
For example:
meetings with health authorities, congresses, investigator meetings (Scope of change)All operations within the company【組織 / Organizational Context】
- Reports to Clinical Pharmacology Senior Director or higher, within Early Development
- May have direct reporting global or regional clinical pharmacologists
- May have functional management of scientists 【応募要件 / Qualifications】 Education
- PhD or PharmD with fellowship in clinical pharmacology Experience
- At least 7 years post-graduate experience, in pharmaceutical industry.
- Thorough knowledge of current and emerging scientific standards and global regulatory requirements including familiarity with relevant guidances
- Working knowledge of assigned therapeutic area, biomarkers, bioanalytical methods, immunogenicity
- Have thorough understanding of early development, clinical methodologies, POC, and clinical endpoints within a specific therapeutic area
- Knowledge of biologics drug development
- Excellent written and oral communication skills and ability to convey complex technical information clearly
- Expert knowledge of clinical pharmacology in drug development, with a strong scientific and strategic mindset and experience with clinical dose setting (including first in human dose setting) and pharmacokinetic/pharmacodynamic relationships
- Experience integrating modeling and simulation activities (i.e., population PK, exposure-response and physiologically based PK) to support the clinical pharmacology plan
- Adaptability and curiosity to learn about new modalities and apply core clinical pharmacology principles to novel therapeutics
- Curiosity and drive to ask questions, learn and keep abreast of literature
- Confidence and ability to present to and influence senior leaders
- Ability to critically analyze problems and provide creative/innovative solutions
- Ability and confidence to work independently
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