Fellowship Positions Available
Global Clinical Science and Epidemiology
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs. The company has its corporate headquarters in Allschwil/Basel, Switzerland where it was founded in 1997. Currently there are roughly 2,500 employees worldwide in over 30 operative affiliates around the world including the United States, Canada, Brazil, Australia, Japan, Switzerland and a number of EU countries. At inception, the initial company focus was in PAH with Actelion scientists being among the first to work in the field of endothelin receptor antagonists (ERA), leading to Tracleer® and now the tailored ERA Opsumit®. Now, Actelion research has significantly expanded beyond PAH, with ongoing clinical development in late phase development (Ph2 and Ph3) in the anti-infectives (cadazolid Ph3 in Clostridium difficile), CNS and immuno-inflammation (ponesimod in Ph3 in multiple sclerosis, and Ph2 in Graft versus host disease and in systemic lupus erythematous).
Actelion Clinical Research, Inc., located in Cherry Hill, New Jersey, is the US clinical development office for Actelion Pharmaceuticals Ltd. Actelion’s fellow would work in this office, which is dedicated to providing strategic input representing US scientific, medical and regulatory perspective into global clinical development.
In partnership with the Rutgers University Institute for Pharmaceutical Industry Fellowships, the program at Actelion will aim at providing a longitudinal experience from protocol development for Ph2 - 3 clinical studies up to study completion. The fellow will be included in the Actelion Clinical Trial Team (CTT) where the fellow will be trained on study conduct and oversight.
The fellow will be assigned a preceptor, highly experienced in clinical development, who will oversee his/her training and ensure that during the two-year fellowship program all predefined learning objectives are adequately covered, from both local and international perspectives.
The program will provide the following:
- Development of a sound understanding of the science and medicine in the assigned therapeutic area, with support for annual attendance at a US conference/congress in the applicable therapeutic area(s).
- Experience drafting study documents such as protocols, informed consents, as well as the clinical section of the investigator brochure, and the clinical section of regulatory documents,g., INDs, briefing books.
- International exposure in clinical science and exposure to other areas of drug development (e.g., preclinical) by an immersion visit to Actelion European headquarters in Switzerland (minimum one visit/year).
- Interaction with study sites and investigators through monitoring visits with Actelion clinical monitors as well as attendance at investigator meeting
- Work in tandem with epidemiologist to provide input to the design and conduct of observational studies.
- Support epidemiologist to provide input to the clinical development plan (CDP) in terms of patient population availability and access, pattern of treatment, and contribution to study feasibility.
- The opportunity to perform literature reviews as well as contribute to the development of position papers.
- Required training on Actelion Standard Operating Procedure (SOPs), Good Clinical Practice (GCP) standards and clinical development-related