Biopharmaceuticals - Clinical Development Unit Head (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Oberhaching (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 224541BR


Stellenbeschreibung

- Leitende(r) Angestellte(r) gemäß § 5 BVG -

• Leads one main area of clinical development (a CDU) and provides oversight and coaching to the Global Program Medical Directors. May serve as deputy for the Head BCD, e.g. on decision boards and key external meetings
• Is a core member of and may chair the Protocol Review Committee
• Is a key contributor of the strategy of the organization
• Guides and actively oversees the quality of clinical development plans, study designs and protocols, result interpretation, reports, clinical summaries for submission, and publications for projects in the CDU area
• Discusses protocols, results, etc. with Health Authorities verbally and in writing and is responsible for clinical contributions to submissions
• Responsible for efficient use of resources to deliver optimal results
• Able to recruit Global Program Medical Directors and members of the CDU, provides on-the-job coaching and implements individual development plans
• Develops and supports partnering with other Sandoz development functions and Novartis Divisions
• Develops and supports external contacts (investigators, academia, regulators)
• Contributes to the Biosimilar education effort with key external audiences



Research & Development


Mindestanforderungen

• MD or equivalent required; relevant clinical specialty or subspecialty training preferred
• Fluent English (oral and written), strong scientific writing skills
• Min 10 years of global drug development or clinical research experience
• Advanced expertise in clinical trial designs, translational medicine (biomarker and PD marker), (or basic research laboratory), result analysis, biostatistics knowledge
• Experience in dossier submission/review and major Health Authority interactions required
• Demonstrates the courage to assume personal accountability in challenging situations
• Critical and strategic thinker. Has a track record of execution of complex programs/trials/projects.
• Has managed teams in a matrix structure or line function in a global organization, ideally across several geographic areas.
• Strong communication skills essential, both oral and written. Presents information confidently and effectively to executives, peers, and direct reports, one-on-one or in groups
• Strong leadership skills are essential. Successfully creates and leads high performing teams, empowering and motivating people by inviting input, and sharing ownership and visibility, embraces the D&I idea



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