Biopharmaceuticals - Global Program Medical Director (m/f/d)
|Standort||Holzkirchen (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
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!
• 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
What you’ll bring to the role:
• Medical degree or PhD in life sciences, 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 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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