Biopharmaceuticals - Global Program Medical Director (m/f/d)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 257353BR


Stellenbeschreibung

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:

• Lead the International Clinical Team (ICT), and serve as clinical core team member of the International Project Team (IPT). Ensure alignment between program strategy and clinical development activities
• Lead author of the Clinical Development Plan. Lead the identification of the medical and clinical development implications of pre-clinical findings, drug formulation constraints, regulations and any other findings preceding the start of the first-in-human clinical study
• Accountable for the clinical development program from both strategic and day-to-day operational perspective
• Accountable for medical training of all relevant contributors to clinical development of assigned compounds
• Lead and/or contribute to multidisciplinary tasks forces to support continuous improvement in BCD
• Establish sound and trustful relationship within IPT and with all internal and external partners
• Adapt activities to the ever changing regulatory and operational requirements and environment

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Research & Development


Mindestanforderungen

What you’ll bring to the role:

• Medical degree, additional training in areas such as statistics and pharmacokinetics desirable
• At least 10 years of clinical development experience in industry including:
- Experience in conducting phase 3 clinical trials from design to reporting
- Experience in regulatory submissions, reviews and approvals in at least a major region (e.g. EU, US or Japan)
- Knowledge of advanced clinical trial design, statistics and pharmacokinetics
- Proven ability to interpret, discuss and represent efficacy and safety data
• More than 5 years people management experience which may include management in a matrix environment; global people management experience desired
• Proven learning agility: comfortable with complexity and able to explain complexity in simple words.
• Excellent English (oral and written)


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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