Biopharmaceuticals – Preclinical Development Manager (m/w/d)
|Standort||Holzkirchen (near Munich)|
|Funktionsbereich||Research & Development|
|Art der Stelle||Vollzeit|
8 biosimilars across immunology, oncology and endocrinology are already on the market, Sandoz Biopharmaceuticals has a leading biosimilars pipeline with additional molecules in various stages of development. As Preclinical Development Manager, you contribute to the future success of our biosimilars development and you are responsible for providing nonclinical expertise to assigned global cross-functional biosimilar program teams and leading the timely planning and execution of innovative and tailored nonclinical development programs.
Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives? Join Sandoz!
A division of Novartis, Sandoz is a global leader in Generic and Biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide.
• Is the Preclinical Development representative in global cross-functional and clinical project teams and provides general nonclinical expertise to assigned biosimilar programs from early strategic planning to post-approval in close collaboration with Analytical Characterization, Clinical Development and Medical Affairs
• Sets up and leads the timely, quality planning and execution of the nonclinical development programs which includes a thorough assessment of the requirement for animal studies according to guidelines and 3R principles using a step-wise approach (in silico knowledge-based, in vitro, in vivo)
• Interprets the nonclinical in vitro and in vivo pharmacology and safety data, including decision analysis, regulatory acceptability and issue resolution and translates nonclinical study data into clinical strategy and study design
• Provides pharmacology expertise for in vitro functional characterization and bioassay strategy and ensures an integrated assessment of nonclinical and in vitro bioassay data
• Supports the selection and implementation of PD markers and biomarkers into clinical study designs according to general project and study objectives and in alignment with Clinical Pharmacology, Bioanalytics and other relevant line functions
• Compiles nonclinical and PD marker/biomarker documentation for regulatory authorities and contributes to other relevant sections of regulatory dossiers
• Assures quality of studies and study results according to the appropriate SOPs, GLP and other guidelines/regulations in compliance with Sandoz/Novartis guidelines
• Can represent function in Due Diligence / in-licensing activities
What you’ll bring to the role:
• Doctoral degree in biological / life sciences
• Excellent communication skills in English, knowledge of German a plus
• 5+ years of previous industry experience in biotherapeutic drug development in a global matrix environment
• 3+ years or equivalent multi-/cross-functional team experience
• Excellent knowledge of current literature, regulatory guidelines for drug development, concepts and controversies in nonclinical pharmacology and safety
• Knowledge of innovative nonclinical study design (in vitro, in vivo), statistics and pharmacokinetics
• Experience in the development of monoclonal antibodies
• Experience as company representative during interactions with regulatory authorities
• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits
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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