Laurent B. Nicolas
|Actelion Pharmaceuticals Ltd.|
Area:Clinical Pharmacology- Phase 1 development studies
Clinical Pharmacologist, PhD at Actelion Pharmaceuticals Ltd
2008 – Present (less than a year)
- Directly and/or indirectly manage projects in the department of clinical pharmacology (CP).
- Plan, design, conduct, evaluate, report and publish CP studies in liaison with appropriate line managers.
- Write study protocols, reports and NDAs within agreed time frames and ensure that they meet regulatory requirements
- Responsible for the pharmacokinetic (PK), pharmacodynamic (PD) and PK/PD components of development plans .
- Represent/assist the Clin pharm dpt in life cycle management teams and in meetings with investigators, experts and health authorities.
- Collaborate closely with representatives from other line units such as preclinical pharmacokinetics, pharmacology, toxicology, CMC, and clinical development.
Clinical Science Specialist, PhD at Hoffmann-La Roche