Clinical Pharmacologist

Clinical Pharmacologist

Responsibilities

• Develop the ability to work independently and flexibly under supervision and provide deliverables in good quality and in a timely manner
• Ability to pro-actively gather relevant clinical pharmacology knowledge related to assigned compounds and willingness to undertake relevant internal/external training courses
• Compliance with internal working practices/SOPs, quality control procedures, and regulatory guidelines
• Leadership of phase I/IIa studies including writing and/or review of clinical trial protocols and other trial-related documents to deliver on time, on budget, and with the appropriate quality
• Contribution to the writing of the clinical sections of regulatory or safety-related documents (e.g., Investigator's Brochure, IMPD, briefing books, DSUR, CP sections of NDA)
• Comprehensive understanding of the science related to a trial and/or project
• Response to scientific/medical inquiries from IEC/IRB and/or Health Authorities
• Responsibility for data review prior to database lock
• Responsible for all aspects of trial protocols, reports, statistical analysis plans, project summaries, and development plans
• Preparation of or contribution to scientific publications and position papers, including supportive literature reviews
• Provision of input/expertise to the PK/PD section of protocols for phase IIb-IV studies
• Comprehensive understanding of science/medicine related to a project together with a broad, innovative, science-based, and forward-looking strategy
• Elaboration of the Clinical Development Plan for the assigned compound when in early-stage development (i.e., phase I and II) and/or contribution to it when in later stages of development.
• Elaboration of CP trial plans for assigned projects
• Development and maintenance of contacts with key opinion leaders and investigators
• Development of line management experience (with support from the line manager as necessary)
• Willingness and ability to travel as required
• Ability to keep data, related documentation, and files in a well-organized manner
• Ability to carry out PK, PD, and PK/PD analysis using WinNonlin or similar software, graphical presentations, interpret and summarize resulting data
• Ability to work in a matrix environment and adequately manage the interaction with multiple stakeholders by providing timely, good-quality feedback and input
• Ability to simultaneously handle and oversee multiple tasks, to adapt to changing project needs and to prioritize in a high-pace environment
• Ability to elaborate good-quality CP trial protocols

Required Skills

• Experience in designing, conducting, and analyzing CP studies
• Experience in PK/PD evaluation techniques and knowledge about associated regulatory guidelines
• Understanding of the roles and responsibilities of relevant functions involved in a clinical trial
• Knowledge of ICH-GCP and other relevant guidance documents/regulations for clinical trial authorization
• Knowledge of and experience in interacting with other departments involved in drug development
• Scientific/pragmatic approach to data analysis and interpretation with necessary attention to details
• Highly self-motivated, proactive working attitude
• Well-developed interpersonal skills including ability to act as a team player
• Clear communication style (verbal and written)
• Adequate general IT skills (e.g., MS office)