Clinical Pharmacologist (7143)

Role Overview

Join a high-potential biopharmaceutical company headquartered in Switzerland, a leading hub for European biotech. Specialized in the discovery, development, and commercialization of innovative small molecules, this organization aims to transform the horizon of therapeutic options. This position is based in the Basel area and is available for an initial 24-month contract.

The role involves contributing to the design, conduct, analysis, interpretation, and reporting of clinical pharmacology trials across drug development. You will provide scientific and medical input to trial teams, support protocol and trial document development, and contribute to regulatory and cross-functional activities. The position also supports PK/PD data interpretation, trial planning, and communication of trial results, performed in close collaboration with internal stakeholders and under appropriate line management supervision.

Individual Responsibilities

• Develop the ability to work independently and flexibly under supervision, providing deliverables in good quality and in a timely manner.
• Pro-actively gather relevant clinical pharmacology knowledge related to assigned compounds and undertake relevant internal or external training courses.
• Ensure compliance with internal working practices, SOPs, quality control procedures, and regulatory guidelines.
• Lead phase I/IIa studies, including writing and reviewing clinical trial protocols and other trial-related documents to deliver on time, on budget, and with appropriate quality.
• Contribute to the writing of clinical sections of regulatory or safety-related documents, such as Investigator's Brochures, IMPDs, briefing books, DSURs, and CP sections of NDAs.
• Maintain a comprehensive understanding of the science related to a trial and/or project.
• Respond to scientific and medical inquiries from IEC/IRB and/or Health Authorities.
• Take responsibility for data review prior to database lock.
• Manage all aspects of trial protocols, reports, statistical analysis plans, project summaries, and development plans.
• Prepare or contribute to scientific publications and position papers, including supportive literature reviews.
• Provide input and expertise to the PK/PD section of protocols for phase IIb-IV studies.
• Develop a broad, innovative, science-based, and forward-looking strategy alongside a comprehensive understanding of science and medicine related to a project.
• Elaborate the Clinical Development Plan for assigned compounds in early-stage development (phase I and II) and contribute to it in later stages.
• Elaborate CP trial plans for assigned projects.
• Develop and maintain contacts with key opinion leaders and investigators.
• Develop line management experience with support from the line manager as necessary.

Shared Responsibilities

• Attend CP group and other educational meetings with active contribution, including presentations when requested.
• Contribute to the selection and supervision of negotiations with CROs (clinical, data management, biostatistics, and bioanalytical) and manage monitoring aspects.
• Act as the primary liaison person in the CP trial team, providing appropriate input regarding medical and scientific aspects related to a trial and/or project.
• Contribute to the preparation of submission documents to Independent Ethics Committees/Institutional Review Boards (IEC/IRB) and Health Authorities.
• Interpret and present trial results to the Life Cycle Team, Development Team, and externally when appropriate (e.g., scientific advisory board, investigator meeting, congress, health authorities).
• Collaborate closely with the Modeling and Simulation group within CP.
• Attend scientific meetings and review literature to remain aware of the latest clinical and scientific developments related to a project.
• Represent CP in the context of due diligences.
• Serve as the CP representative within the project team for one or several projects, providing clinical pharmacology expertise at trial/project team and other relevant meetings.
• Promote communication and alignment across line functions in the project team.
• Participate in Health Authority meetings as a CP representative and contribute to regulatory documents, such as briefing books.

Qualifications and Experience

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required.
• Strong academic background, i.e., MSc (or equivalent), preferably a PhD, PharmD, and/or MD.
• 1-2 years of clinical research experience in an academic or industry environment, preferably with drug development experience in a Pharmaceutical/Biotechnology company.
• Experience in designing, conducting, and analyzing CP studies and the ability to elaborate good-quality CP trial protocols.
• 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 and pragmatic approach to data analysis and interpretation with necessary attention to details.
• Highly self-motivated and proactive working attitude.
• Well-developed interpersonal skills including the ability to act as a team player.
• Clear communication style (verbal and written).
• Adequate general IT skills (e.g., MS Office) and the ability to keep data, related documentation, and files in a well-organized manner.
• Willingness and ability to travel as required.
• Ability to carry out PK, PD, and PK/PD analysis using WinNonlin or similar software, create graphical presentations, and interpret and summarize resulting data.
• Ability to work in a matrix environment and adequately manage interaction with multiple stakeholders by providing timely, good-quality feedback and input.
• Ability to simultaneously handle and oversee multiple tasks, adapt to changing project needs, and prioritize in a high-pace environment.
• Fluency in English is mandatory.