Clinical Evidence Lead (PDF)

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Clinical Evidence Lead
You will be part of our small but growing team in Clinical Development. Together with
Clinical Application and Clinical Outcomes, Clinical Development is one of the three
specialized teams that make up Department of Clinical Value Proposition and Evidence.
Clinical Evidence Lead to BK Medical
Clinical Development consist of a team of highly experienced Clinical Scientists and Clinical • Support Post Market Clinical Follow-up activities
Evidence Leads. Our main responsibilities are to drive the clinical strategies to ensure
• Author the Clinical Development Plan
timely execution on clinical deliverables to support regulatory submissions and commercial
strategies. We are an international team who value cultural and personal diversity in an
• Perform literature search/reviews to maintain surveillance of published literature
informal, friendly, and respectful atmosphere. We strive to apply data driven methodologies
and clinical results
and evidence-based decision making, in our daily work. At the same time, we value a
Your professional background could be
balanced and pragmatic approach to problem solving in a fast-growing company in a
dynamic environment.
• Ba. or higher degree in the Life Sciences or related disciplines with:
Key responsibilities for our new Clinical Lead
• A minimum of 5 years direct experience in clinical development of
medical devices
• Leads the clinical development and clinical data strategy for an allocated application
area
• Demonstrated expert knowledge and comprehensive understanding of
applicable GCP, ICH guidelines & FDA, MDR and relevant applicable
• Lead wording, substantiation, and documentation of clinical claims for regulatory
international guidelines and regulations
compliance and commercial utilization
• Excellent interpersonal, written/verbal communication & organizational
• Leads the clinical evidence activities in development projects and gives input to
skills
PMCF
• Strong program management and financial skills
• Defines clinical milestones and project deliverables
• Fluent verbal and written English language
• Supports clinical evaluation activities and documentation
• Willing to travel domestically and internationally, as required
• Supports post market clinical activities including PMCF
We look forward to receiving your application, in which you describe 1) what your
• Collaborates in the development of regulatory strategies for market approvals
motivation is for becoming part of our Clinical Development team and 2) which of your
• Provides ad hoc support and guidance on activities and documentation requiring
experiences and skills you will particularly contribute.
clinical competences
For more information regarding the position, please reach out to Sr. Manager, Head of
Typical tasks to do
Clinical Development, Trine Tølbøll - [email protected].
• Ensure the development and implementation of clinical evidence strategies
We are looking forward to hearing from you.
• Develop documentation of clinical claims and their substantiation
BK Medical
BK Medical is a market leader within active imaging and has
always been committed to designing systems that help surgeons
visualize anatomy and lesions, guide interventions, and navigate
inside the human body. BK Medical is an international company
with sales offices all over the world, a global headquarter in Boston,
Massachusetts (US), a European headquarter located in Herlev,
Denmark, and a transducer manufacturing site in State College,
Pennsylvania, US.
The company employs approximately 800 FTEs globally and
almost 300 FTEs in Herlev. In 2021, BK Medical was acquired by
GE Healthcare. With this acquisition, GE Healthcare adds the fast-
growing and relatively new field of real-time surgical visualization to
GEs pre- and post-operative Ultrasound capabilities, creating an
end-to-end offering through the full continuum of care from
diagnosis through therapy and beyond. Through significant
synergies with the benefit of GEs technology and commercial
scale, BK Medical will be able to reach new customers and markets
around the world.
Our Headquarter in Herlev are placed in lovely and modern
buildings. The work atmosphere is casual, and our organizational
structure is flat. We have a good staff canteen focusing on health
and variety, we have private health insurance and pension plans as
well as social joint events and several staff clubs.
BK designer ultralydssystemer, der hjælper kirurger med at scanne,
styre, foretage indgreb og navigere inde i menneskekroppen
Urolog Neurokirurg HPB-kirurg
Kolorektal kirurg Robotkirurg Andre markedsbrugere
BK Medical
Global organisation
“By working within these
BK Medical er en international virksomhed med salgskontorer over hele verden. Vores europæiske hovedkontor
ligger i Herlev tæt på København.
specialties, I realized that I could
Hos BK Medical støtter vi, at vores medarbejdere udvikler deres kompetencer og viden. Vi er en professional og
provide or improve the health care
uformel organisation med fleksible arbejdsvilkår og en flad struktur.
system that way.”
Vi er effektive og fører vores ideer ud i livet i form af stærke produkter – hvilket gør BK Medical til en spændende
og udviklingsorienteret arbejdsplads.
- Rikke von Barm, Specification Engineer
Vi glæder os til at byde dig velkommen i et team der gør en forskel – en forskel for livet.
Intraoperativ ultralyd
BK Medical er engageret i af at designe ultralydssystemer, der hjælper kirurger med at scanne, styre, foretage
indgreb og navigere inde i menneskekroppen. Vores kunder er kirurger og spænder fra HPB-kirurger,
neurokirurger og robotassisterede kirurger til urologer, kolorektale kirurger med flere.
Vores mission er at muliggøre intraoperativ vejledning i realtid under kirurgiske indgreb ved at give kirurger de
nødvendige oplysninger til straks at træffe kritiske beslutninger. Vores produkter er designet og tilpasset til
kirurgiske indgreb for at hjælpe kirurger med at spare tid og opnå resultater.
Nu fremmer BK Medical sin mission med GE Healthcare. Sammen vil vi nå ud til flere kunder og fortsætte med at
give kirurger mulighed for at træffe kritiske beslutninger, der giver mulighed for bedre pleje, hurtigere procedurer
og reducerede komplikationer.
BK Medical er markedsledende og arbejder tæt sammen med eksperter og universiteter for at levere de bedste
“I chose to pursue a career in the
løsninger til kliniske udfordringer.
medtech industry because I want
Forskning og udvikling
to work at a place where both the
BK Medical har udviklingsafdelinger i Danmark og USA. Det største udviklingsteam har til huse i Danmark. Vi
company and the colleges always
udvikler software, hardware, mekanik, signalbehandling og avancerede algoritmer.
strives for achieving better.”
Når det gælder forskning, har vi samarbejdet med Danmarks Tekniske Universitet (DTU) i mere end 20 år.
Sammen har vi gennemført 2 højteknologiske projekter til avanceret ultralydsskanning.
- Rasmus H. Rossen,
Senior Mechanical Engineer
Vi deltager for øjeblikket i et storstilet projekt med DTU, Rigshospitalet og Københavns Universitet om ultralyd
med ekstrem høj opløsning.
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