CLINICAL OPERATIONS MANAGER (Temporary)
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology.
In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco, and China, as well as a product presence in approximately 190 countries globally.
For our Clinical Research Division in Lugano we are looking for a:
CLINICAL OPERATIONS MANAGER
- Coordination and implementation of the clinical operations activities for all assigned clinical trials related to the molecule(s) of competence, ensuring good management in terms of quality, time and costs in collaboration with the project team and the involved CRO(s). Coordination of activities related to clinical operations with other departments.
- Participation in the drafting, critical revision and finalization of the clinical development plan for the molecule(s) assigned.
- Definition of study protocols related to either clinical trials included in the development plan and/or post-registration clinical trials planned in the Life Cycle Management plan.
- Support CRO evaluation and selection.
- General management of the clinical CRO(s) and other vendors (as applicable) involved in the execution of assigned study related activities, and supervision of such activities.
- Definition, collection and implementation of all technical documents of competence related to clinical trials to be submitted to ethics committees and regulatory authorities.
- Support preparation of drug supply plans and drug supply activities.
- Review of the data and final results of individual clinical trials and contribution to the drafting of documents included in the registration dossier.
- Collection and analysis of critical information with possible impact on the development of the assigned molecule(s). Identification of critical areas in the development project with planning and implementation of contingency plans, when required.
- Develop and consolidate know-how in the therapeutic area of competence.
- Contribute to the evaluation of new molecules when required, with particular focus on clinical study data quality.
The successful candidate has the following qualifications:
- At least 5 years of experience in planning, conducting and managing clinical trials, including clinical monitoring, project management or similar experience gained working at a pharma company or CRO.
- Degree in science (pharmacy, chemistry, biochemistry, medicine, biology, etc.)
- Analytical skills, accuracy and synthesis capabilities as well as strategic vision and organizational skills are required.
- Knowledge of English, written and spoken, is mandatory.
- Both, the use of informatics tools and willingness to travel outside the usual place of work are required.
- Excellent interpersonal relation with colleagues and functions external to the company, as well as ability to work in a team and also independently.
- Sensitivity and flexibility in the management of challenges; strategies feeling in defining additional activities when facing particular scientific evidences.
Helsinn Healthcare SA is offering attractive conditions and a pleasant working environment in a highly motivated team.
Please send relevant application with CV to: