340340BR
Mar 14, 2022
Germany

Job Description

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 biosimilar development. You are responsible for providing nonclinical expertise to assigned global cross-functional biosimilar program teams, leading the timely planning and execution of innovative and tailored nonclinical development programs.

This position is part time 50%.

Your key responsibilities:
Your responsibilities include, but not limited to:
• You are the Preclinical Development representative in global cross-functional, clinical, technical (CMC) and scientific project teams and provide 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.
• You provide pharmacology expertise and are responsible for the design of the nonclinical in vitro development strategy for functional characterization of the biosimilar in a x-functional team including a thorough assessment of the requirement for animal studies according to guidelines and 3R principles.
• You are responsible for leading the timely execution of the nonclinical development programs with high quality according to the appropriate SOPs, GLP and other guidelines/regulations and in compliance with Sandoz/Novartis guidelines.
• You interpret the nonclinical in vitro and in vivo pharmacology and safety data, including decision analysis, regulatory acceptability and issue resolution and translate nonclinical study data into clinical strategy and study design.
• You support 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, Clinical Bioanalytics and other relevant line functions.
• You are responsible for compiling nonclinical modules for market authorization applications and PD marker/biomarker documentation for regulatory authorities and contribute to other relevant sections of regulatory dossiers. You are the functional representative in Health authority interactions.
• You can represent function in Due Diligence / in-licensing activities.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:
• Doctoral degree in biological / life sciences
• Excellent communication skills in English
• 6+ years of previous industry experience in biotherapeutic drug development in a global matrix environment
• 4+ years or equivalent multi-/cross-functional team experience, also in leading these teams
• Experience in the development of monoclonal antibodies, incl. structure/function relationship and assessment of critical quality attributes. Experience with small molecules is a plus.
• Expert knowledge of current literature, regulatory guidelines for drug development, concepts and controversies in nonclinical pharmacology and safety
• Experience with Translational Pharmacology / Research
• Excellent knowledge of innovative nonclinical study design (in vitro, in vivo), statistics and pharmacokinetics
• Experience as company representative during interactions with regulatory authority agencies
• Geman language skills are a plus

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. Our choice of responsibility concept also gives you the possibility to work from home.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!


Commitment to Diversity & Inclusion:
Sandoz is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.

The law provides for severely disabled / equal applicants the opportunity to involve the local representative body for disabled employees (SBV) in the application process. If you would like to request this, please let us know in advance as a note on your CV.


Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
SANDOZ
BioPharma SZ
Germany
Holzkirchen (near Munich)
Research & Development
Part Time
50
Regular
No
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340340BR

Preclinical Development Manager (d/f/m) - Part time 50%

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