Biopharmaceuticals - Clinical Development Unit Head (m/f/d)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 257808BR


Stellenbeschreibung

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

1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and world-class expertise and capabilities in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. This opportunity is waiting for you to contribute to Sandoz success story in the area of biosimilar toward the future, at the same time it becomes also the right step up in your career within clinical development!

Your responsibilities:

• 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
• Develops and supports external contacts (investigators, academia, regulators)
• Contributes to the Biosimilar education effort with key external audiences

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Research & Development


Mindestanforderungen

What you’ll bring to the role:

• 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
• 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.


Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Join us, and help reimagine access to medicine.


Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.



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