Clinical Pharmacology Scientist

Proclinical are recruiting a Clinical Pharmacology Scientist to join a biotech establishment. This role is on a contract basis and is located in Basel. The client is focused on offering life-changing treatments for patients across various serious illnesses.

Responsibilities:

• Contribute to planning the IND and NDA documents, reports for formal regulatory meetings such as EOP1, EOOP2 and resources used for presentations and replies to regulatory bodies.
• Support the coordination of the clinical pharmacology factor of the project scientific investigators brochure.
• Guide the current evaluation of the study such as PK, PD and safety, as well as evaluate the data outputs for scientific and medical rationality and reliability.
• Handle the scientific features of clinical pharmacology study procedure development, which involves procedure synopsis, sanction forms, eCRF and procedure alterations.
• You will direct the safety evaluation of clinical pharmacology studies and partake in serious adverse event (SAE) settlement and SAE accounts.
• Manage scribing the final study papers.
• The ideal candidate will attend and offer science assistance for investigator meetings and monitor workshops.
• As the Clinical Pharmacology Scientist, you will guide the review of clinical pharmacology data such as pharmacokinetics, pharmacodynamics, safety, etc., networking with personnel and investigators, data management, biostatistics, and any other partners when needed.

Skills & Requirements:

• Educated to an advanced degree level in a pharmaceutical science, clinical pharmacology science, or similar discipline.
• At least 2+ years of experience in a pharma organisation assisting in clinical pharmacology studies, NCA data analysis, linked DMPK evaluation, regulatory archiving and medical scribing.
• Familiarity with multiple methods to PK and PD data evaluation, such as compartmental, curve-fitting, non-compartmental, etc.
• Prior involvement with softwares such as Phoenix, WinNonlin, Microsoft, Google Suites, Spotfire, etc.
• Experience within a clinical research role ideally within a pharmaceutical organisation with know-how in ICH GCP and the drug development procedure.
• Acquaintance operating within a matrix team focused on the scientific and/or clinical study-linked responsibilities as well as leading a matrix team.
• Works well in a team environment with exceptional social abilities which involves training and guiding on an international, internal and external level.
• Communication skills both verbally and written.
• Fluency in the English language.
• Able to think critically, demonstrate innovation, takes the initiative and is thorough.
• Capable of processing information, assessing data, reaching verdicts based on reasoning and the rationale on the risk - benefit examination and cost-efficiency.
• Ability to operate within a matrix structure for projects.
• Adhere to the company values which are commitment, initiative, open two-way communication, global teamwork trust, accountability, interdependence, consistency, empowerment, sense of urgency, pride, drive to change, courageous leadership, innovation.

If you are having difficulty in applying or if you have any questions, please contact Mohammed Alli at +41 61 568 79 85.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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