Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Senior Investigator (PTM) to be based in Basel for a 12-month contract position.
- Independently represents PK Sciences a core member of discovery, translational medicine and global project teams;
- Participates or leads PKS sub-team to define PKS strategy for compound progression and development;
- Ensure alignment of plans and strategies with sub-teams, project teams, manager and leadership team;
- Analyze and interpret PK/TK/PD/IG data generated during discovery, early and full development; present results and implications to the program;
- Authors and prepares key pre-clinical and clinical, and regulatory documents including , but not limited to: clinical study protocols, clinical study reports, modeling reports, investigator brochures, IND / IMPDs and NDAs within agreed timelines, and meeting all regulatory requirements;
- Adhere in strict accord to the appropriate SOP and GxP guidelines.
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- PhD / Pharm.D. level scientist with relevant experience in drug metabolism and pharmacokinetics or related biologic back ground;
- 10 + years of experience in drug discovery, development or a relevant environment (e.g. Clinical Pharmacology or Drug Metabolism and Pharmacokinetics);
- Extensive and in-depth knowledge of drug metabolism and pharmacokinetics including, pharmacology PK and PK/PD evaluation, Immunogenicity (for PTM roles), techniques, experience in working in project teams (preferably global) and knowledge of regulatory requirements;
- Knowledge of regulatory requirements and experience in dealing with regulatory authorities and experience conducting due diligence;
- Proficient with full range of techniques used in job and core area. Working knowledge of tools and processes used in drug design and development;
- Extensive library research skills and knowledge of problem-solving techniques;
- Sound and robust list of scientific publications and external presentations.