Position: Associate

Job type: Contract

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Job content

Proclinical are recruiting Clinical Pharmacology Scientist for an international business. This is a contract role and is located in Basel, with the availability to work remotely from home. Our client is focused on detecting innovative remedies.

Responsibilities
  • Accountable for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments.
  • Head the analysis of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), co-operating as needed with operational staff and investigators, Data Management, Biostatistics and any other partners.
  • Manage the continuing assessment of study data (e.g. PK, PD and safety) and analyse data outputs for scientific and medical validity and consistency.
  • Support the arrangement of the clinical pharmacology component of the project specific Investigators Brochure.
  • Direct the safety review of clinical pharmacology studies and participate to serious adverse event (SAE) reconciliation and SAE narratives.
  • Attend and offer science support for investigator meetings and supervise workshops.
  • Key scientific accountable for authoring final study reports.
  • Contribute in the formulation of the IND and NDA documentation, the dossiers for official regulatory meetings (e.g. EOP1, EOP2) and resources for use in presentations and replies to regulatory authorities.
Skills & Requirements
  • Obtained MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
  • At least +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, associated DMPK analysis, regulatory filings and medical writing.
  • Former experience / working knowledge of numerous methods to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
  • Prior software experience: Phoenix? WinNonlin? (as well as Microsoft & Google Suites).
  • Experience in clinical research, if possible, in the pharmaceutical business, with familiarity with ICH GCP and the drug development process.
  • Understanding of operating on, and preferably guiding a team matrixed around the scientific and/or clinical study-related responsibilities.
  • Operative teamwork and interpersonal skills (globally, internal and externally) involving training and mentoring.
  • Efficient verbal and written communication/presentation skills in English.
  • Exhibit creativity, critical thinking, initiative and conscientiousness
  • Aptitude to process information, inspect data, and reach conclusions based on sound reasoning and the rationale based on the risk- benefit examination and cost-effectiveness.
  • Familiar with Spotfire? is advantageous but not essential to the role.
  • Operate in a matrix structure for project.
  • Represent function on team(s), answer to rudimentary protocol questions and process issues.
  • Follow company values: Commitment, Initiative, Open Two-way Communication, Global Teamwork Trust, Accountability, Interdependence, Consistency, Empowerment, Sense of Urgency, Pride, Drive to Change, Courageous Leadership, Innovation.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Mohammed Alli on +41 61 568 79 85.

A Full Job Description Is Available On Request.

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

#ClinicalServices

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Deadline: 07-04-2024

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