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Director Clinical Operations - Eysins, Schweiz - Fresenius Kabi

Fresenius Kabi

Geprüftes Unternehmen

Eysins, Schweiz

vor 1 Monat

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

With our corporate philosophy of "caring for life", we are committed to putting essential medicines and technologies in the hands of people who help patients and to finding the best answers to the challenges they face.

In the field of biosimilars, we develop products with a focus on autoimmune diseases and oncology.

Fresenius Kabi SwissBioSim GmbH is specialized in biosimilar medicines and consists of an experienced team of employees located in the Geneva region of Switzerland.

As in all our ranges, Fresenius Kabi is committed to provide high-quality and affordable products for the therapy and care of critically and chronically ill patients.

Fresenius Kabi SwissBiosim has also been certified as an Equal Pay Employer.
Your assignments

Main Tasks:

The Director Clinical Operations is responsible and accountable for planning, coordinating, overseeing and conducting complex global clinical trials in one or more therapeutic areas.
The Director Clinical Operations collaborates in a global environment, using best practices and knowledge of internal and external business issues to improve processes, standards, and services.
The Director Clinical Operations is accountable to plan, drive and monitor program related activities throughout the lifecycle of the project ensuring targets are met according to timelines, budget and quality expectations.
Lead (multiple) crossfunctional teams and drives oversight of CRO's and vendor management and has indepth business knowledge and strategic understanding of how crossfunctional teams jointly achieve objectives and goals of trial team, utilizing knowledge of the organization, processes, customers and key business drivers to increase effectiveness.
Understand the different requirements of agencies related to the clinical packages and plans manages accordingly the different functions (ie CSR, TFLs, ISS etc)
Accountable for inspection readiness
Accountable for CAPAS related to clinical programs within the field of Clinical Operations
Accountable and responsible for the financial planning, budget, accruals, Forecasts
Prepare clinical program updates and/or contribution to them as needed
Support Head Clinical Operations in establishing and monitoring best Clinical Operation Practices.
Support Head Clinical Operations with strategic planning for the new FKSBS assets
Act as Line manager to Clinical Operations personnel

Other Tasks:

Participe in relevant meetings
Plan and set up crossfunctional meetings, meetings with vendors and others as needed
Own and/or contribute to SOP development /reviews

Profile:

Qualifications:

Advance degree in life sciences (graduate degree), e.g. Biology, Chemistry, Pharmaceuticals preferred or medical background
At least 10 years' experience in clinical research in industry, and at least 5 years in clinical trial management
Strong leadership experience in leading teams
Management competencies (leadership, problem solving and decision making skills)
Understanding GxP and global requirements
Strong project management skillsets
Excellent communication skills and ability to manage cross functional teams
Ability to deal with complex situations and drive solution orientated thinking
Fully fluent in English
Excellent team player, ability to work under high pressure and pronounced resiliency
Experience working in an international and crossfunctional team
Ability to present and defend the perspective
Experienced in Microsoft project, Excel, Power point

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