Non-Clinical Project Director
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Shape the future of cell therapy as a Non-Clinical Project Director. Can you drive R&D projects, collaborate with experts, and ensure strategic execution? Ready to take the lead? Apply now! The position As Non–Clinical Project Director you will be responsible for preparing and implementing cell therapy non-clinical development strategies and plans, ensuring that the non-clinical project gates and key deliverables are met. Your responsibilities include preparing, monitoring, and reviewing results from non-clinical studies. You will also be accountable for providing non-clinical input to the Target Product Profiles (TPP) and Product Development Plans (PDP), as well as overseeing the non-clinical Common Technical Document (CTD) deliverables. In this role, you will have interactions with colleagues at all levels in Cell Therapy R&D, as well as with key stakeholders within and outside of Novo Nordisk. Key responsibilities: Drive the planning and execution of assigned Cell Therapy R&D drug development projects Prepare input, and guide external collaborators on the execution of non-clinical studies Ensure execution and follow-up on relevant non-clinical activities in Cell Therapy R&D Plan and conduct the first Safety Committee Meeting to support First Human Dose Manage and follow up on non-clinical parts of project budgets Build, expand, and share knowledge within cell therapy non-clinical development in relevant therapeutic areas such as Parkinson’s disease, neurological disorders, cardiac issues, and diabetes
The position can be based in either Copenhagen, Denmark or Freemont, US. 10% of travel should be expected in this role. Qualifications Preferably you have a Ph.D. or DVM, in life sciences. Possessing expert knowledge and hands-on experience, you demonstrate proficiency in cell therapy non-clinical and basic research methodologies, as well as in all operational procedures associated with planning and conducting cell therapy non-clinical studies. You have substantial experience with strategic and scientific planning aspects of cell therapy non-clinical development programs. Furthermore, to succeed in this position, you have: Experience from external requirements in non-clinical drug development in general, including GLP and relevant guidelines Experience of interacting with key regulatory authorities e.g., FDA, EMA, PMDA Solid understanding of non-clinical, clinical, and regulatory aspects of cell therapy drug development Clear understanding of the R&D value chain, i.e., the various disciplines and their complex interactions Experience with cross-functional, cross-national teams and management of multi-national teams
About the department Cell Therapy R&D is an integrated Transformational Research Unit (TRU) that covers the entire R&D value chain, with Research, CMC & Manufacturing, Device and Clinical Development working closely together in a biotech-like setup. The unit collaborates extensively with external partners and Novo Nordisk colleagues outside the TRU. Preparing and implementing high quality and effective cell therapy development strategies and plans is the core activity in the Cell Therapy Development. This is done with a small, agile cross-functional organisation utilising collaborations, partnerships, and external expertise. The area includes non-clinical development, clinical pharmacology & science, medical specialists, regulatory affairs, and project leadership. The Cell Therapy Development team is also closely involved in assessing the development potential of new project opportunities, recognising that the portfolio will be built on external sourcing as well as in-house research. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Damien Bates, VP – Head of Cell Therapy Development at [email protected] Deadline 24 September 2023. Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. 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 to 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.
The position can be based in either Copenhagen, Denmark or Freemont, US. 10% of travel should be expected in this role. Qualifications Preferably you have a Ph.D. or DVM, in life sciences. Possessing expert knowledge and hands-on experience, you demonstrate proficiency in cell therapy non-clinical and basic research methodologies, as well as in all operational procedures associated with planning and conducting cell therapy non-clinical studies. You have substantial experience with strategic and scientific planning aspects of cell therapy non-clinical development programs. Furthermore, to succeed in this position, you have:
About the department Cell Therapy R&D is an integrated Transformational Research Unit (TRU) that covers the entire R&D value chain, with Research, CMC & Manufacturing, Device and Clinical Development working closely together in a biotech-like setup. The unit collaborates extensively with external partners and Novo Nordisk colleagues outside the TRU. Preparing and implementing high quality and effective cell therapy development strategies and plans is the core activity in the Cell Therapy Development. This is done with a small, agile cross-functional organisation utilising collaborations, partnerships, and external expertise. The area includes non-clinical development, clinical pharmacology & science, medical specialists, regulatory affairs, and project leadership. The Cell Therapy Development team is also closely involved in assessing the development potential of new project opportunities, recognising that the portfolio will be built on external sourcing as well as in-house research. Working at Novo Nordisk At Novo Nordisk, we don’t wait for change. We drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never shy away from opportunities to develop, we seize them. From research and development, through to manufacturing, marketing and sales – we’re all working to move the needle on patient care. Contact For further information, please contact Damien Bates, VP – Head of Cell Therapy Development at [email protected] Deadline 24 September 2023. Applications will be reviewed on an ongoing basis, so we encourage you to apply as soon as possible. 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 to 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.
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 31.8.2023, 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.
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