Project Director, Clinical Development - Cell Therapy
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Are you ready to lead clinical development projects? Do you have experience designing clinical trial synopses and driving biomarker strategies? If yes! Join us as a Project Director, Clinical Development – Cell Therapy at Novo Nordisk and shape the future of cell therapy R&D! The position As Project Director, Clinical Development - Cell Therapy you will drive the planning and execution of assigned Cell Therapy clinical development projects. You will be responsible for the design and outline of early cell therapy clinical development strategies, plans and trials, including authoring clinical trial synopses. You will provide clinical pharmacology and early clinical development input to cell therapy project plans, including addressing scientific questions relevant to trial design and/or assessment of drug development potential, as applicable. Furthermore, you will be responsible for the development of biomarker strategies across our therapeutic areas.You will be in interactions with colleagues at all levels in Cell Therapy R&D and with key stakeholders within and outside Novo Nordisk. Thus, your ability to communicate effectively with people from different organizations, functions, and organizational levels is highly important. Qualifications You hold a university degree in life sciences, which can include an MD and/or a PhD with a completed doctoral thesis. You possess in-depth knowledge of biologics development, including combination device-biologic products, along with a clear understanding of the R&D value chain. You demonstrate expertise and hands-on experience in cell therapy clinical research and development. Additionally, you have substantial experience in strategic and scientific planning for clinical trials and drug development. Hands-on experience in planning and executing clinical pharmacology trials is crucial. Moreover, a deep understanding of translating non-clinical research into clinical development is highly desirable. To be successful in this position you have: Leadership experience in leading global drug/biologic/combination product development projects. Experience in interacting with regulatory authorities such as the FDA, EMA, and PMDA, as well as external scientific advisors. Proven track record of motivating and leading individuals and cross-functional teams. Strong international network with access to key opinion leaders. Ability to navigate tight timelines, high complexity, and diverse tasks. 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 Nasreen Begum, Talent Acquisition Consultant at +4534483665. Deadline 7 August 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 19.6.2023, 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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