8 beste Stellen als director, global regulatory affairs in basel bs – aktuell auf Personalsuche

Serve as Medical Director for the ongoing Fosmanogepix Phase III programme, providing leadership in safety oversight, eligibility assessment, medical data review, query resolution, risk indicator monitoring, blinding oversight, and protocol/document review. Ensure robust oversight of external medical monitoring activities at Clinical Research Organisations and manage external consultants
Build and maintain investigator networks to accelerate enrolment in the Fosmanogepix Phase III programme, working closely with the Clinical Study Team
Contribute to strategic planning, including Fosmanogepix positioning, clinical development plans, and competitor analysis
Support the Fosmanogepix Expanded Access Program
Act as a key medical interface with the Medical and Global Affairs department to ensure alignment and collaboration
Support portfolio planning for selected programmes, providing medical expertise to guide decision-making
Drive process improvements and innovation, delivering efficiency gains and scalable solutions for clinical development activities
Prepare for and actively participate in health authority meetings, ensuring high-quality medical input and representation
Serve as the internal and external subject matter expert on medical issues related to assigned development products
Lead advisory boards and engage with key investigators, fostering scientific exchange and collaboration
Contribute to company publications and support external scientific projects to advance knowledge and visibility
Provide cross-functional medical support, advising on clinical development aspects for Communications, Commercial, and other relevant functions

Your profile

Medical Degree (MD) with clinical experience in a hospital setting.
Strong expertise in Infectious Diseases; formal training (e.g., Facharzt, Fellowship, or equivalent) is highly desirable
Hands-on experience managing severe infections, such as invasive fungal infections or infections caused by drug-resistant pathogens, is an advantage
Industry experience in Clinical Development, particularly with antibiotics and/or antifungals, is preferred but not essential
Familiarity with regulatory interactions and health authority processes would be beneficial
Additional training in medical statistics is an asset
Fluency in English is required; proficiency in other languages is an advantage

Why us?

Basilea is committed to putting people first. In addition to competitive remuneration, we offer the opportunity to work on inspiring, cross-functional projects in an engaging working environment.
We strongly believe that every employee can make an impact and is vital to our success. If you wish to become part of a company that strives to make a difference to the lives of patients worldwide, we are looking forward to receiving your application via e-mail to [email protected]. Additional information can be found on our website www.basilea.com.

About us

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. Basilea has about 190 employees. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba® for the treatment of invasive fungal infections and Zevtera® for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN).

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