P2609 Senior Trial Master File (TMF) Specialist

Debiopharm is an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique development only business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.

At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action saving lives our collective target.

We are currently looking for a motivated and collaborative professional to join ourGlobal Clinical OperationsDepartment(R&D)based at our Headquarters in Lausanne Switzerland as

Senior Trial Master File (TMF) Specialist

Permanent role Lausanne Switzerland

Your Mission:Ensuring Excellence and Inspection-ReadinessofClinicalTrialDocumentation

As aSenior TMF Specialist you will be the guardian of our Trial Master Files supporting Clinical Trial Teams fromtrialsetup through to final archiving. Your role is critical in ensuring that our clinical documentation is compliant of the highest quality and always ready for regulatory inspection.

YourKeyResponsibilities

• eTMF Stewardship:Serve as the Clinical Business Administrator for theDebiopharmeTMFsystemprovidingfirst-line support totheusersand contributing to validation activities.

• Quality&Oversight:Drive thehealthof the TMF byimplementingrisk-basedqualityreviewsandoverseeingTMFcompletenessforbothinternalandoutsourcedtrials.

• Metrics & Performance:Establish KPIs and report on TMF quality and performance to help Clinical Trial Teamsmaintainhigh standardsof oversight.

• InspectionReadiness:support theteamsduringaudits inspections and due diligenceactivities.

• Continuous Improvement:Identifyimprovement opportunities drive cross-functional TMF initiatives and contribute to the evolution of SOPs and training tools.

• ExpertGuidance:Provideongoingtraining andguidancetoteammemberstobuildglobalawarenessof TMFregulatoryrequirements.

YourProfile

• Education:Bachelors orMasters degree in Science Healthcare orequivalent experience inarelevantdiscipline.

• Experience:At least 3 years in the pharmaceutical industry with hands-on experience in clinical trials and TMF documentation/systems.

• Expertise:Solid knowledge of Good Clinical Practice (GCP) and advancedproficiencyin managing digital clinical systems.

• Languages:Fluent inEnglish;proficiencyin French or another European language is a distinct asset.

• Soft Skills:A strong communicator and team leader capable of building effective relationships across internal and external functions. You are highly organized detail-oriented and excel at planning.

WhatweOffer:

• Being part of a company where innovation collaboration and impactarentjust values theyrehow we work every day

• Partner with teams across disciplines at the forefront of oncology and anti-infective development

• An inclusive and respectful workplace proud to be Equal-Pay certified

• Grow in a culture that values people purpose and performance

• A chance to grow share and shape the future of healthcare

What to Expect in the Recruitment Process:

If your application is selectedyoullbe invited to interviews with Talent Acquisition and the Hiring Manager via Teams followed by apanelinterview and reference checks. Communication is handled via Workablecheck your spam folder for emails from*@.

Please contact our HR Department prior tosubmittingany profiles. We cannot accept unsolicited applications from agencies or recruiters.

Required Experience:

Senior IC