Vacancy details

General information

Reference number

Information about Molecular Partners AG

Founded in 2004 by a group of PhD students as a spin-off from the University of Zurich, Molecular Partners AG is a thriving and steadily growing clinical stage biotech company located in Zurich-Schlieren (Switzerland) with 125 highly qualified employees.

In order to advance modern medicine and significantly improve the management of serious diseases, we have developed and successfully established a powerful new class of potent, specific and versatile small protein therapies, called DARPin® therapeutics.

The continuous development of a broad portfolio of therapeutic product candidates in oncology and ophthalmology based on the company’s proprietary DARPin® platform allowed a successful listing of the company on the SIX Swiss Exchange (ticker: MOLN). Next to our own pipeline of drug candidates we have entered into collaborations with leading international pharmaceutical companies, including Allergan, Amgen, Roche and Janssen Pharmaceuticals.

The highly dedicated, multi-disciplined team at MP is committed to developing breakthrough medicines for serious diseases.

Job details

Position title

Clinical Trial Manager M/F

Job description

The Clinical Trial Manager (CTM) will be responsible for all activities related to the operational planning, execution and reporting of clinical trials sponsored by MPAG.  This challenging and diverse position will include the following tasks and responsibilities:

• Head the internal clinical study team 


• Ensure all trial deliverables are met according to timelines, budget, operational procedures and quality/GCP standards


• Oversight of clinical trial budget and management of required updates


• Main point of contact for CRO, third party vendors and study sites to ensure sponsor’s oversight responsibilities


• Oversee the CRO performance and ensure appropriate measures are implemented to assure an adequate protection of the rights, safety and well-being of trial subjects, and the quality and integrity of the clinical trial data


• Management of interfaces and definition of operational specifications (e.g. facilitate bid templates) for MPAG versus clinical research vendors (e.b. CRO, laboratories) for conduct of clinical trials


• Ensure optimal administrative/operational monitoring of clinical studies (may include participation in feasibility assessments, site selection, site visits/co-monitoring, management of Investigator/study site interactions, etc.)


• Development/preparation/coordination of relevant sections of clinical study protocols and related documents in collaboration with CROs; development of study tools, guidelines, and training materials; management of clinical study material and implementation of issue resolution plans


• Contribute to the development of clinical sections of regulatory documents, such as IBs/briefing books/safety updates/CTA/BLA submission documents, responses to Health Authority (HA) questions, etc. as needed


• Ensure maintenance of Trial Master File in strict compliance with ICH/GCP and internal SOPs, and ensure clinical documents are filed in appropriate designations (e.g. regulatory repository) and an up-to-date audit trial is maintained


• Assist with drug/lab supply management for the clinical trials


• Update regularly all trial information databases and tracking systems in order to manage accuracy of information


• Support development of standard processes, planning and resource management tools and performance metrics to achieve excellence in clinical program management

Requirements

For this attractive position, we are looking for a highly motivated individual bringing along:

• Degree or equivalent education in life science/healthcare


• Good understanding of the international aspects of drug development process, including knowledge of international standards (GCP/ICH), health authorities (FDA, EMA), local/National Health Authority regulations


• Minimum of 5 - 8 years of experience in clinical trial execution in a biotech or pharmaceutical company or contract research organization


• Proven track record of managing a clinical trial from setup to clinical study report (including setup of eCRF, IVRS/IWRS, laboratory related tasks, etc.)


• CRO and site management capabilities with demonstrated ability to solve problems and mediate potential compliance issues


• Experience and natural ability of leading cross-functional teams


• Strong organizational and communication skills


• Proficiency in English, German is considered an asset


• Computer literacy

Our offer

Partnership and collaboration are at the core of our company, our research activities and our product candidates. Molecular Partners offers an international working environment and the opportunity to collaborate with outstanding individuals from numerous disciplines, who contribute to our shared goals of scientific excellence, respectful teamwork and personal aspiration.

We foster true innovation and creative thinking to advance our therapeutic product candidates and continue to be inspired by the difference we can make for our patients.

At Molecular Partners you will discover a challenging job, inspiring colleagues and a true purpose. If you are interested in working at Molecular Partners, we are looking forward to hearing from you! Please submit your detailed curriculum vitae via our career portal.

We only accept online applications.

Job location

Job location

Switzerland, Zürich, Schlieren

Preferred head hunter clause

Please note Molecular Partners AG operates a list of preferred recruitment partners. For those partners who have no valid, signed agreement in place with Molecular Partners AG, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Molecular Partners AG (including any of its subsidiaries, affiliates or related companies) are not subject to payment of any form of introduction, placement or referral fees.

Molecular Partners AG, Wagistrasse 14, CH-8952 Zurich-Schlieren, Switzerland.

www.molecularpartners.com