The CMM will facilitate execution of clinical trials related to New Therapy Areas including CKD (Chronic Kidney Disease), CVD (Cardiovascular Disease), Liver Disease, inflammation and Alzheimer's disease (AD), by providing medical/scientific expertise and advice based on interactions with KOLs, independent professional associations and patient advocacy associations as necessary.
The role will report to the Clinical Medical Manager Lead.Other role tasks are as follows but is not limited to:
Identify and map KOLs (Key Opinion Leaders), investigators and research centres within the relevant therapy areas, work closely with clinical operations teams in CDC (Clinical Development Center), region, IO-SO and HQ during feasibility and allocation process, and engage with relevant patient advocacy groups and investigate areas of mutual interest and potential collaboration.
Collect medical insights that may be of value to Novo Nordisk and cascade these as relevant to region as well as across teams within local affiliate/CDC, optimizing the feasibility process for the clinical trial conduct.
The role will also identify and regularly engage with clinical experts in relevant TAs to obtain guidance relevant to clinical trial execution and ensure site staff at main site and referral centres are properly trained.
Act as subject matter expert within relevant TAs, provide leadership in the scientific community within New Therapy Areas (TA) conducting advisory boards, scientific meetings, guidelines, publications and engaging with local associations for HCPs (healthcare Professionals) on relevant topics, as well as aid in the process on Investigator Sponsored studies by contributing to evaluation of proposals and ensuring follow up after approval in close collaboration with local Medical Affairs team, lead process of mapping of clinical care pathways for new TAs, and help with ad hoc requests by providing scientific and medical responses to requests in a timely manner.
Contribute to delivering successful clinical trials (phase I-IV) in collaboration with clinical operations, performing ad hoc and planned visits, supporting attendance at investigator meetings, ensuring KOL inclusion in clinical trials, and engaging key investigators to convey trial results, as well as to scientific retention and recruitment (SRR) activities at local level.
Provide timely guidance and internal training by supporting training creation and delivering training to clinical staff, as well as CMR, commercial and MAPA cross functional teams.
Qualifications MD (Medical Doctor) or Ph.D. in healthcare with strong clinical and preferably research background, alternatively Pharmacist or Master of Science with strong, relevant background.
Must have a minimum of 3 years of clinical or pharmaceutical industry experience, with solid experience with human healthcare research either from university or pharmaceutical industry.
Expert in therapeutic area of relevance, preferably with authorship in peer-reviewed journals. Experience as clinical trial investigator or sub-investigator is preferred.Knowledge on the specificities and nuances of the local healthcare infrastructure, as well as of pharmaceutical drug development Must have good communication skills and proficiency in both Japanese and English languages.
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 hold 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.
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Clinical Medical Manager
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