Senior Nonclinical Project Manager/Toxicologist
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Måløv
If you are curious about cell therapy development, ideally with some experience of it, and aspire to be a nonclinical coordinator and toxicologist in a team-oriented “biotech-like” working environment, this could be an exciting opportunity for you.
Apply now for a life-changing career!
The position
You will, together with your team, be responsible for the nonclinical strategies, plans and safety assessments in our cell therapy development projects, and you will serve as consultant on nonclinical development matters within Cell Therapy R&D.
In your role you will be:
• Preparing and implementing cell therapy nonclinical development strategies
• Monitoring, reviewing, and evaluating results from nonclinical toxicity studies
• Providing high quality nonclinical safety assessments
• Ensuring timely nonclinical input to regulatory documents and discussing cell therapy nonclinical matters with regulatory authorities
• Guiding external partners on the execution of cell therapy nonclinical programs
You will be coordinating complex cross-functional nonclinical related tasks, taking an active role in finding new ways of working to increase effectiveness in cell therapy development.
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and skills to encourage and influence colleagues, governance, and key stakeholders. You will report to the Head of Cell Therapy Development in Cell Therapy R&D. The position is based in Måløv, Denmark and international travelling is part of the job.
Qualifications
To be a successful candidate, we expect that you have most of the following:
• An academic degree, PhD or MSc, in Life Sciences (e.g. veterinary medicine, toxicology, pharmaceutical sciences or biology)
• In-depth knowledge of nonclinical drug development and safety assessments, including a solid understanding of GLP and relevant guidelines
• Excellent analytical skills with a systematic approach to identifying root causes and innovative ways of solving problems
• Experience of interacting with key regulatory authorities e.g. FDA, EMA, PMDA
• Experience of navigating within an environment of tight timelines, high-complexity, non-standards, and diverse tasks in known and new therapy areas
• Advanced level written and spoken English, including excellent oral and written communication, presentation and listening skills
On a personal level, you are a dedicated team player who inspires trust and gain recognition among colleagues and stakeholders. You thrive in a complex and changing environment while at the same time having a quality mindset and focus on advancing projects, meeting deadlines, and communicating effectively.
About the department
Cell Therapy R&D is a Transformational Research Unit within the Novo Nordisk Research & Early Development EVP area. We are more than 200 employees and cover the whole cell therapy R&D value chain, from research to product approval. Our current portfolio includes projects for treatment of type 1 diabetes, Parkinson’s disease, dry age-related macular degeneration, and chronic heart failure.
The Cell Therapy Development area includes non-clinical development, clinical development, regulatory affairs, and project leadership. We are a small, dedicated team with our ways of working built to a high degree on collaborations and partnerships.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
For more information, please contact Niklas Öhrner, Head of Cell Therapy Development at +4530792512
Deadline
20 November 2022
Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Apply now for a life-changing career!
The position
You will, together with your team, be responsible for the nonclinical strategies, plans and safety assessments in our cell therapy development projects, and you will serve as consultant on nonclinical development matters within Cell Therapy R&D.
In your role you will be:
• Preparing and implementing cell therapy nonclinical development strategies
• Monitoring, reviewing, and evaluating results from nonclinical toxicity studies
• Providing high quality nonclinical safety assessments
• Ensuring timely nonclinical input to regulatory documents and discussing cell therapy nonclinical matters with regulatory authorities
• Guiding external partners on the execution of cell therapy nonclinical programs
You will be coordinating complex cross-functional nonclinical related tasks, taking an active role in finding new ways of working to increase effectiveness in cell therapy development.
The role requires the ability to work effectively with people from different functions and organisational levels, calling for high cultural awareness and skills to encourage and influence colleagues, governance, and key stakeholders. You will report to the Head of Cell Therapy Development in Cell Therapy R&D. The position is based in Måløv, Denmark and international travelling is part of the job.
Qualifications
To be a successful candidate, we expect that you have most of the following:
• An academic degree, PhD or MSc, in Life Sciences (e.g. veterinary medicine, toxicology, pharmaceutical sciences or biology)
• In-depth knowledge of nonclinical drug development and safety assessments, including a solid understanding of GLP and relevant guidelines
• Excellent analytical skills with a systematic approach to identifying root causes and innovative ways of solving problems
• Experience of interacting with key regulatory authorities e.g. FDA, EMA, PMDA
• Experience of navigating within an environment of tight timelines, high-complexity, non-standards, and diverse tasks in known and new therapy areas
• Advanced level written and spoken English, including excellent oral and written communication, presentation and listening skills
On a personal level, you are a dedicated team player who inspires trust and gain recognition among colleagues and stakeholders. You thrive in a complex and changing environment while at the same time having a quality mindset and focus on advancing projects, meeting deadlines, and communicating effectively.
About the department
Cell Therapy R&D is a Transformational Research Unit within the Novo Nordisk Research & Early Development EVP area. We are more than 200 employees and cover the whole cell therapy R&D value chain, from research to product approval. Our current portfolio includes projects for treatment of type 1 diabetes, Parkinson’s disease, dry age-related macular degeneration, and chronic heart failure.
The Cell Therapy Development area includes non-clinical development, clinical development, regulatory affairs, and project leadership. We are a small, dedicated team with our ways of working built to a high degree on collaborations and partnerships.
Working at Novo Nordisk
Novo Nordisk is its people. We know that life is anything but linear, and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing.
Contact
For more information, please contact Niklas Öhrner, Head of Cell Therapy Development at +4530792512
Deadline
20 November 2022
Please note that applications will be assessed on an ongoing basis and therefore the advert may close before the recruitment process is completed if we have proceeded with candidates to the screening or interview phase.
You do not need to attach a cover letter to your application, but please include a few sentences about why you are applying in your resume or CV.
To ensure an efficient and fair recruitment process, please refrain from adding a photo in your CV.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.
Print job Send to e-mail
Information og data
Denne ledige stilling har jobtypen "Forretningsudvikler", og befinder sig i kategorien "Kommunikation, marketing, salg".
Arbejdsstedet er beliggende i Måløv.
Jobbet er oprettet på vores service den 13.10.2022, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Forretningsudvikler
- Måløv
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