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Clinical Project Manager

Alvotech Swiss AG

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Clinical Project Manager

Alvotech is a privately owned biopharmaceutical company focused on the development and
manufacturing of high quality biosimilars for global markets. At Alvotech, our goal is to become a
global leader in the biosimilar space and to deliver high quality and cost competitive products to
our partners and to patients worldwide.

Our product development pipeline is developed in Research & Development centers across
Europe and will be manufactured in our state-of-the-art facility located in Reykjavik Iceland.

Within Alvotech Switzerland we are currently recruitung a
Clinical Project Manager
Main Function: The Clinical Project Manager (CPM) will be responsible for the operational and logistic aspects of the assigned clinical program(s). Within this role, the CPM will be responsible
for adhering to regular planning of tasks in accordance with clinical program timelines, performing
the required activities to keep the assigned clinical program(s) on budget, on time and with the
highest standard of quality. In addition, the CPM will be the primary point of contact for any
program related issue, both internally and with external stakeholders. Most important tasks of the job: - Implement, monitor, supervise and direct the assigned Clinical program(s) - Ensure all program deliverables are met according to timelines, budget, operational
procedures and quality / GCP standards - Supervise maintenance of Trial Master File (TMF) in strict compliance with ICH/GCP and
internal Standard Operating Procedures (SOPs) - Streamline interactions with relevant internal functions, by leading and coordinating the Clinical
Project Team - Keep regular interaction with CRO and trial sites to ensure sponsor’s oversight responsibilities - Develop / prepare relevant sections of clinical trial protocols and related documents in
collaboration with internal stakeholder and CROs - Develop clinical sections of regulatory documents - Prepare and share information (e.g. PowerPoint slides, Word document, Excel
Spreadsheets) about clinical trial updates for internal and external team meetings (e.g.
regular updates, CRA training, Investigator’s meeting) - Support the Head of Clinical Operations (Head Clinops) activities when necessary - Keep tracking of program budget, reviewing and approving invoices - Implement and update / improve policies, SOPs and Work Instructions (WIs), as required

The primary location for this role is Alvotech‘s office in Zurich. It is expected that Clinical Project
Manager will have to travel internationally, as required by the Clinical Trial activities.
Organizational Structure: - The Clinical Project Manager will report to and will be supervised by the Head Clinops , within
the Clinical Development Department.
Qualification and Experience:
Education: Minimum: MSc; Desirable: Pharm.D. or Ph.D. or equivalent

Languages: Fluent in English, both written and verbal. Any additional language is a “nice to have“.

Knowlegde: : Proficient in use of a PC and common Microsoft packages such as Word, Visio,
Excel, Powerpoint. Extensive knowledge of GCP and other relevant ICH/regulatory guidelines.

Experience: 7+ years in relevant functions in the Pharmaceutical Industry, or equivalent. Proven
leadership skills and demonstrated ability to interact collaboratively in a cross-functional
environment required. Subject matter expertise in clinical operations and related activities.
Previous experience conducting clinical trials in Europe/US and some Asia-Pacific regions in an
outsourcing model is necessary, along with a working knowledge of the EMEA and FDA
clinical/regulatory environment.

As a team player you manage to build a team spirit. You are tolerant and considerate to be an
active and open communicator and share knowledge and experience with other team members.
You have a hands – on attitude as well as a result-orientated way of work. You coordinate,
participate and make positive contribution to team meetings.
We offer: To be part of a growing team dedicated to improving access-to-medicine, we offer opportunities
to bring forward ideas, lead change and ongoing opportunities for personal development and
growth in an international company.

Candidates should apply to Jozefina Mijatovic (Ms.): jozefina.mijatovic@alvotech.com Join our Alvotech team and be part of our growth!