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 Novartis Group of Companies?
927 million. That’s how many lives our products touched in 2017. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?

We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.

We are Sandoz, a Novartis Division. Join us and help reimagine medicine.

We develop breakthrough treatments and find new ways to deliver them to as many people as possible to improve and extend peoples’ lives. We do this, by supporting and promoting the knowledge and strengths of our employees and specifically use them to deepen our understanding of our patients and customers. Motivating conditions and an attractive salary are also part of our working environment, as well as our company culture, which is based on collaboration, curiosity, enthusiasm, courage and integrity.

Novartis 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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