Einführung

Aufgabenbeschreibung

• 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

Erforderliches Profil

• 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

Application process