Global Clinical Pharmacology Manager (m/f)

SANDOZ
Division SANDOZ
Geschäftseinheit BioPharma SZ
Standort Holzkirchen (near Munich)
Funktionsbereich Research & Development
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 259430BR


Stellenbeschreibung

• Develop clinical pharmacology, PK and PD strategy for Biosimilar development programs
• Contribute to elaborating strategies that may complement or substitute for clinical outcomes to streamline Biosimilar clinical programs
• Provide expert Clinical Pharmacology counsel to the International Project and Clinical Teams, and other cross functional teams
• Ensure quality of the clinical pharmacology plans, project specifications, study protocols, reports, summaries and publications
• Responsible for designing and analyzing the PK and PD components of clinical trials in all phases of development
• Provide the PK/PD sections of clinical protocols, clinical study reports, Investigator’s Brochures, Health Authority Briefing Books, CTD (Common Technical Document) summaries, and any other relevant document for Health Authority submissions
• Ensure representation as needed for all health authority interactions
• Establish efficient collaboration with key partner functions within and outside BCD



Research & Development


Mindestanforderungen

• Advanced degree (PhD, PharmD, MD) in life sciences is required (clinical pharmacology, pharmacokinetics or related discipline)
• Minimum 5-7 year’s experience in the area of preclinical and clinical pharmacology and pharmacokinetics or related field in a pharmaceutical based company
• Expert knowledge in preclinical and clinical drug development, especially for biologics
• Demonstrated proficiency using analysis tools (e.g. Phoenix, SAS, NONMEM, R)
• Contribution to successful development and registration of multiple global products
• Demonstrated leadership in a matrix organization
• Excellent English written, verbal and presentation skills, German of advantage
• Strong critical thinking and problem solving skills


Why consider Novartis?

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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