Scientist Clinical Pharmacology and Immunology
Proclinical are recruiting for a Scientist Clinical Pharmacology and Immunology to join a biotech organisation. This role is on a permanent basis.
- Accountable for Bioanalytics e2e procurement process, and for handling contracts with bioanalytical labs.
- Work alongside both clinical operations and clinical CRO to guarantee adequate PK/PD and immunogenicity sample gathering, management, handling and shipment.
- Cooperate with project management to be in line with timelines and budget in the general development plan.
- Participate in inspection promptness by archiving bioanalytical papers in the eTMF and prepare for inspections.
- Partake in regulatory proposals, briefing books and consultations with health authorities regarding bioanalytical and clinical pharmacology and immunology subjects.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to an advanced degree level in a scientific field.
- Fluency in the English language with knowledge in another language would be advantageous.
- Communication skills both verbally and in writing.
- Demonstrable experience in R&D within a biopharma/biotech organisation.
- Familiarity with offering scientific oversight for bioanalytical projects placed at CROs.
- Acquaintance within bioanalytical sciences such as in preclinical/clinical studies linked to PK, immunogenicity or biomarker assays, diagnostic lab or central lab.
- Expertise on scientific best practices, GCP, GLP as well as in regulatory guidelines.
- Operated within an international organisation within a field of assisting or conducting drug development would be ideal.
- Analytical and troubleshooting abilities.
- Action/results driven individual with interpersonal capabilities.
If you are having difficulty in applying or if you have any questions, please contact Sam Kennaugh at firstname.lastname@example.org.
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.