Providing Flexible Resourcing Solutions
CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a specialist staffing organisation based in
Basel, London and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe,
with contract and permanent placements in clinical development, data management, statistics, regulatory affairs
and medical marketing.

For one of our clients, we are currently looking for a

                               Clinical Pharmacology Expert
Reference Number:         10-13-807-CPE-W
Type of placement:        Permanent
Location:                 Switzerland, Basel


Purpose:

Support oncology drug development by providing clinical pharmacology / Drug Metabolism and
Pharmacokinetic (DMPK) expertise across early and full development phases, and global medical
affairs. Represent Oncology Clinical Pharmacology (OCP) global line function on cross-functional
teams and influence design, execution, and analysis of clinical pharmacology / DMPK related study
components.


Main Responsibilities:

       Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and
        regulatory documents including clinical study protocols, clinical study reports, investigator
        brochures, Investigational New Drug (IND) / Investigational Medicinal Product Dossier
        (IMPD)’s and New Drug Application (NDA)’s within agreed timelines, and meeting all
        regulatory requirements under minimal guidance from manager.
       Designs clinical pharmacology strategy for assigned program and coordinates
        pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identifies
        potential project hurdles, suggests solutions and establishes contingency plans. Represents
        OCP on Global Program Team(s) or early project teams.
       Performs or oversees Pharmacokinetic (PK) and Pharmacokinetic/Pharmacodynamics (PK /
        PD) analyses using a variety of tools and approaches. Integrates, interprets and reports data
        to project teams and other customers.
       Ensures constructive collaboration within drug development teams and with other internal
        partners (e.g. DMPK, Toxicology, Modeling and Simulation, Formulations, Drug Regulatory
        Affairs, Clinical Development).
       Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical requirements in
        the OCP and/or preclinical project development plans.
       Monitors study timelines, objectives and budgets, ensures accuracy of project progress in
        company tracking tools (e.g. Succeed). Assures rapid and effective communication of data to
        project teams.
       Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team
        members and/or prepares summary documentation.
       Maintains and enhances technical and drug development expertise (e.g. training courses,
        external meeting attendance).May act as technical subject matter expert in key clinical
        pharmacology / DMPK related area.
       Attends meetings with external parties including investigators, outside experts, and health
        authorities.
       May manage one or more junior OCP associates.Coaches and mentors other OCP
        associates.


  Should you be interested in the above position and wish to apply, please send your application with your CV,
            quoting the above reference number, to our recruitment team at recruitment@ctcon.ch

                     CTC Clinical Trial Consulting, Greifengasse 1, CH 4058 Basel, Switzerland
                 Tel.: +41 61 695 88 66    Fax: +41 61 695 88 67    www.ctcon.ch    info@ctcon.ch
Qualifications and Experience:

       Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with
        appropriate post-doctoral training
       6 - 10 years of relevant post doctoral, academic, industry or government experience
       Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug
        development process
       Demonstrated experience using in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial
        Simulator, GastroPlus, SymCyp)
       Demonstrated experience and ability to work successfully as part of cross functional team in a
        highly dynamic, matrixed, project team environment
       Excellent oral and written communication skills
       Strong organizational and project skills
       Expert critical thinking and problem solving skills including publications / presentations.
       Strong influencing and negotiating skills
       Coaching, mentoring, and people management skills
       Effective oral and written communication skills in English
       Relevant working/residency permit or Swiss/EU-Citizenship required


Our offer:

    Competitive salary and package
    Wide range of career opportunities in a large pharmaceutical organisation
    International experience




  Should you be interested in the above position and wish to apply, please send your application with your CV,
            quoting the above reference number, to our recruitment team at recruitment@ctcon.ch

                     CTC Clinical Trial Consulting, Greifengasse 1, CH 4058 Basel, Switzerland
                 Tel.: +41 61 695 88 66    Fax: +41 61 695 88 67    www.ctcon.ch    info@ctcon.ch

Clinical Pharmacology Expert

  • 1.
    Providing Flexible ResourcingSolutions CTC Resourcing Solutions, founded in Basel, Switzerland in 1997, is a specialist staffing organisation based in Basel, London and Munich, providing flexible resourcing solutions to the pharmaceutical industry across Europe, with contract and permanent placements in clinical development, data management, statistics, regulatory affairs and medical marketing. For one of our clients, we are currently looking for a Clinical Pharmacology Expert Reference Number: 10-13-807-CPE-W Type of placement: Permanent Location: Switzerland, Basel Purpose: Support oncology drug development by providing clinical pharmacology / Drug Metabolism and Pharmacokinetic (DMPK) expertise across early and full development phases, and global medical affairs. Represent Oncology Clinical Pharmacology (OCP) global line function on cross-functional teams and influence design, execution, and analysis of clinical pharmacology / DMPK related study components. Main Responsibilities:  Contributes expert pharmacokinetic / DMPK input into key pre-clinical and clinical, and regulatory documents including clinical study protocols, clinical study reports, investigator brochures, Investigational New Drug (IND) / Investigational Medicinal Product Dossier (IMPD)’s and New Drug Application (NDA)’s within agreed timelines, and meeting all regulatory requirements under minimal guidance from manager.  Designs clinical pharmacology strategy for assigned program and coordinates pharmacokinetic / DMPK related elements for preclinical and/or clinical projects. Identifies potential project hurdles, suggests solutions and establishes contingency plans. Represents OCP on Global Program Team(s) or early project teams.  Performs or oversees Pharmacokinetic (PK) and Pharmacokinetic/Pharmacodynamics (PK / PD) analyses using a variety of tools and approaches. Integrates, interprets and reports data to project teams and other customers.  Ensures constructive collaboration within drug development teams and with other internal partners (e.g. DMPK, Toxicology, Modeling and Simulation, Formulations, Drug Regulatory Affairs, Clinical Development).  Defines and updates as appropriate the PK, PK/PD, DMPK biopharmaceutical requirements in the OCP and/or preclinical project development plans.  Monitors study timelines, objectives and budgets, ensures accuracy of project progress in company tracking tools (e.g. Succeed). Assures rapid and effective communication of data to project teams.  Leads or participates in OCP or project sub-teams. Coordinates with appropriate sub-team members and/or prepares summary documentation.  Maintains and enhances technical and drug development expertise (e.g. training courses, external meeting attendance).May act as technical subject matter expert in key clinical pharmacology / DMPK related area.  Attends meetings with external parties including investigators, outside experts, and health authorities.  May manage one or more junior OCP associates.Coaches and mentors other OCP associates. Should you be interested in the above position and wish to apply, please send your application with your CV, quoting the above reference number, to our recruitment team at recruitment@ctcon.ch CTC Clinical Trial Consulting, Greifengasse 1, CH 4058 Basel, Switzerland Tel.: +41 61 695 88 66 Fax: +41 61 695 88 67 www.ctcon.ch info@ctcon.ch
  • 2.
    Qualifications and Experience:  Ph.D. in pharmacokinetics, drug metabolism or a related discipline, or a Pharm. D. with appropriate post-doctoral training  6 - 10 years of relevant post doctoral, academic, industry or government experience  Expert knowledge of related disciplines (e.g. DMPK, toxicology, regulatory) and the drug development process  Demonstrated experience using in silico analysis tools (e.g. WinNonlin, SAS, NonMEM, Trial Simulator, GastroPlus, SymCyp)  Demonstrated experience and ability to work successfully as part of cross functional team in a highly dynamic, matrixed, project team environment  Excellent oral and written communication skills  Strong organizational and project skills  Expert critical thinking and problem solving skills including publications / presentations.  Strong influencing and negotiating skills  Coaching, mentoring, and people management skills  Effective oral and written communication skills in English  Relevant working/residency permit or Swiss/EU-Citizenship required Our offer:  Competitive salary and package  Wide range of career opportunities in a large pharmaceutical organisation  International experience Should you be interested in the above position and wish to apply, please send your application with your CV, quoting the above reference number, to our recruitment team at recruitment@ctcon.ch CTC Clinical Trial Consulting, Greifengasse 1, CH 4058 Basel, Switzerland Tel.: +41 61 695 88 66 Fax: +41 61 695 88 67 www.ctcon.ch info@ctcon.ch