Clinical Operations Lead (permanent contract/Full-time job - based in Lugano)

Helsinn is a fully integrated, global biopharma company headquartered in Lugano, Switzerland. It is focused on improving the lives of cancer patients all over the world with a leading position in cancer supportive care and innovative pipeline of cancer therapeutics.

Helsinn is a third-generation family-owned company, that since 1976 has been focused on improving the lives of patients, guided by core values of respect, integrity and quality. It operates a unique licensing business model with integrated drug development and manufacturing capabilities. Helsinn has a commercial presence in 190 countries either directly, with operating subsidiaries in the U.S. and China, or via its network of long-standing trusted partners.

Helsinn plays an active and central role in promoting social transformation in favor of people and the environment. Corporate social responsibility is at the heart of everything we do, which is reinforced in the company’s strategic plan by a commitment to sustainable growth.

To learn more about Helsinn Group please visit www.helsinn.com

 

For our Clinical Operations & Services Team - Clinical Research & Development department - in Lugano we are looking for a:

 

CLINICAL OPERATIONS LEAD (Permanent contract/Full-time job)

 

Responsibilities include:

 

  • 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.