- Région Basel
- Type de contrat Temporary full time
- Secteur d'activité Pharmaceutical / Biotechnology / Chemical
As a preferred supplier for Roche Basel, we are looking for an individual as
Clinical Pharmacology Scientist (contract for 1 year, with possible extension). The earliest start date is within 3 months.
Description de la mission
- Responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments
- Leads the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners
- Leads the ongoing review of study data (e.g. PK, PD and safety) and reviews data outputs for scientific and medical validity and consistency
- Assists in the preparation of the clinical pharmacology component of the project specific Investigators Brochure
- Attends and provides science support for investigator meetings and monitor workshops
- Leads the safety review of clinical pharmacology studies and contribute to serious adverse event (SAE) reconciliation and SAE narratives
- Primary scientific responsible for writing final study reports
- Participates in the preparation of the IND and NDA documentation, the dossiers for formal regulatory meetings (e.g. EOP1, EOP2) and materials for use in presentations and responses to regulatory authorities
- MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
- +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, associated DMPK analysis, regulatory filings and medical writing.
- Previous experience / working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
- Experience on software: PhoenixⓇ WinNonlinⓇ (plus Microsoft & Google Suites)
- Clinical research experience, preferably in the pharmaceutical industry, with knowledge of ICH GCP and the drug development process
- Experience of working on, and preferably leading a team matrixed around the scientific and/or clinical study-related tasks.
- Effective team work and interpersonal skills (globally, internal and externally) including coaching and mentoring
- Highly effective verbal and written communication/presentation skills in English
- Shows creativity, critical thinking, initiative and conscientiousness
- Ability to process information, analyze data, and reach conclusions based on sound reasoning and the rationale based on the risk- benefit assessment and cost-effectiveness.
Nice to haves
- Knowledge of SpotfireⓇ is a plus.
- Work in a matrix structure for project
- Represent function on team(s); respond to basic protocol questions and process issues
- Values: Commitment, Initiative, Open Two-way Communication, Global Team Work Trust, Accountability, Interdependence,
- Consistency, Empowerment, Sense of Urgency, Pride, Drive to Change, Courageous Leadership, Innovation
Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.
- Agence GPP AG - GLOBAL RECRUITMENT - +41 44 266 50 25
- Publié le 20. Juni 2022
- Consultant Jie Zhu