Bayer ist ein weltweit tätiges Unternehmen mit Kernkompetenzen auf den Life-Science-Gebieten Gesundheit und Agrarwirtschaft. Als Innovations-Unternehmen setzt Bayer Zeichen in forschungsintensiven Bereichen. Mit seinen Produkten und Dienstleistungen will Bayer den Menschen nützen und zur Verbesserung der Lebensqualität beitragen. Bayer schätzt die Leidenschaft seiner Mitarbeiterinnen und Mitarbeiter für Innovationen und gibt ihnen die Kraft, Dinge zu verändern.

Global Clinical Lead Rare Diseases, Cell&Gene Therapy

YOUR TASKS AND RESPONSIBILITIES

Under the direction of the Therapeutic Area Head, the Global Clinical Leader (GCL) has a broad leadership and strategic responsibility for a project or part of a project in clinical development of a newly identified therapeutic compounds or oversees the optimization of a profile of existing compounds in new indications or therapeutic targets. 

The GCL is responsible to drive the design, execution, and delivery of a development plan, often beginning at Phase 1 and continuing through Phase 3 and market authorization. Through the development of relationships with outside experts, organizations and agencies, and aligned with the goals of Business Development, Medical Affairs, the GCL uses his/her expertise and experience to support clinical development programs, licensed product maintenance, and external licensing/collaboration activities.

As part of a cross functional team, the GCL represents and leads the clinical function by providing medical/scientific, technical, and managerial direction and is expected to champion and present program/project decisions to higher leadership. In collaboration with the Global Program Head, the GCL has responsibility for assessing required resources, timelines and budget, and is required to establish and maintain a close relationship with other core team members and extended study teams to assure a closely coordinated program of activities based on common objectives. 

Key Tasks and Responsibilities:

• Lead a clinical team which has responsibility for operationalizing, delivery, and oversight of activities for effective development of new drugs.  


• Provide clinical leadership as a member of the Global Program Team (GPT) and be the primary point of contact for the assigned project(s)


• Create and translate Target Product Profile's into clinical strategy; prepare and write the Clinical Development Plan, Pediatric Investigational Plan, Clinical Trial Protocol, Investigator Brochures, and Clinical Study Reports


• Partner with the regulatory function in negotiating with world health authorities (FDA, EMA, etc)


• Establish, lead, and manage relationships with key internal/external stakeholders


• Represent the team in other decision/governance meetings, senior management meetings or advisory boards

WHO YOU ARE

The successful candidate will be ‘hands on’, shows drive, is goal directed, and is able to motivate teams to ensure that goals and objectives are delivered efficiently and effectively.  The candidate should approach problems with curiosity and open-mindedness and is able to integrate different ideas and perspectives to deliver innovative ideas and quick and efficient solutions.

The candidate is expected to be an experienced drug developer with preference to candidates who have experience across different therapeutic areas and/or be able to show creative or innovative approaches to clinical trial design with a focus in orphan drug indications/rare disease.

Required Qualifications:

• M.D., DO, MBBS (or established clinical experience) and at least five years of applicable industry experience


• Able to independently perform duties required for leading drug development to registration or IND filing


• Experience in study design, protocol writing, study performance, data collection and interpretation, as well as experience dealing with global health authorities; and familiar with the regulatory and legal environments


• Strong communication skills (fluent in English both written and spoken) to ensure that project plans and status are transparent; risks, issues, and results are clear to all involved parties


• High level of comfort/success working in a matrix environment (global/multi-cultural/cross-functional) including contributing and building trust, clarity, collaboration, and a result-oriented environment;


• Champions new ideas takes on risk, and is able to effectively establish and deliver on realistic plans, action steps and timetables for projects and assignments

We are looking forward to receiving your application by 15th May. Thank you!

#LI-CH

Ihre Bewerbung

Sie suchen eine Herausforderung, in der Sie Ihre Leidenschaft für Innovationen einbringen können? Sie möchten Teil eines globalen Teams werden und gemeinsam mit uns das Leben auf der Welt verbessern? Dann bewerben Sie sich online mit Ihren vollständigen Bewerbungsunterlagen (Anschreiben, Lebenslauf, Zeugnisse).

Bayer begrüßt Bewerbungen aller Menschen ungeachtet von ethnischer Herkunft, nationaler Herkunft, Geschlecht, Alter, körperlichen Merkmalen, sozialer Herkunft, Behinderung, Mitgliedschaft in einer Gewerkschaft, Religion, Familienstand, Schwangerschaft, sexueller Orientierung, Geschlechtsidentität oder einem anderen sachfremden Kriterium nach geltendem Recht. Wir bekennen uns zu dem Grundsatz, alle Bewerberinnen und Bewerber fair zu behandeln und Benachteiligungen zu vermeiden.

Land: Schweiz
Standort: Basel
Referenzcode: 143439
Funktionsbereich:Klinische Entwicklung

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