Life Molecular Imaging GmbH
Life Molecular Imaging GmbH (LMI) is a German-based Research & Development (R&D) organization focused on developing PET imaging and radiotheranostics solutions for diseases with high unmet medical needs. Our vision is to build our position as an innovator and leading player in the Nuclear Medicine field. We aim to create value for patients & physicians by improving early detection and characterization of chronic and life-threatening diseases leading to better therapeutic outcomes and improved quality of life.
We are currently seeking to fill a full-time role situated in our head office in Berlin, Germany:
Main Tasks & Responsibilities :
Execution of the overall strategy for LMI ́s pipeline in cardiovascular indication
Oversee company sponsored clinical research in cardiovascular indications, including input
on study related documents
Supervision of medical and safety aspects of ongoing clinical trials
Support launch strategies, life-cycle management, and expansion of indications for use
Provide Support for medical publications
Liaise with Health competent authorities to drug access (early access, compassionate use or
registry programs)
Maintaining awareness of internal and external developments (scientific, clinical,
competitive, and regulatory) that could impact the development plan
Attend relevant scientific meetings and conferences and support development of summaries
of key data, presentations or symposium
Implementation of applicable guidelines of the quality assurance system of Life Molecular
Imaging
Ensure compliance with applicable local and global laws, regulations, guidelines and
company policies and procedures
Neuraceq^® - Product Indications And Use
PRODUCT INDICATIONS AND USE: Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate β-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's Disease (AD) and other causes of cognitive decline. A negative Neuraceq scan indicates sparse to no neuritic plaques and is inconsistent with a neuropathological diagnosis of AD at the time of image acquisition; a negative scan result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive Neuraceq scan indicates moderate to frequent amyloid neuritic plaques; neuropathological examination has shown this amount of amyloid neuritic plaque is present in patients with AD, but may also be present in patients with other types of neurologic conditions as well as older people with normal cognition. Neuraceq is an adjunct to other diagnostic evaluations.
Limitations: Limitations of Use
A positive Neuraceq scan does not establish the diagnosis of AD or any other cognitive disorder. The safety and effectiveness of Neuraceq have not been established for Predicting the development of dementia or other neurologic conditions or monitoring responses to therapies.
Neuraceq scan results are indicative of the presence of brain neuritic β-amyloid plaques only at the time of image acquisition and a negative scan result does not preclude the development of brain neuritic β-amyloid plaques in the future.
Radiation Risk
Neuraceq, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [see Dosage and Administration.
ADVERSE REACTIONS:
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
OVERDOSAGE
A pharmacological overdose of Neuraceq is unlikely given the relatively low doses used for diagnostic purposes. In the event of administration of a radiation overdose with Neuraceq, the absorbed organ dose to the patient should be reduced by increasing elimination of the radionuclide from the body by inducing frequent micturition.
Skills :
Experience/ Education :
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS
Risk for Image Misinterpretation and other Errors
Errors may occur in the Neuraceq estimation of brain neuritic β-amyloid plaque density during image interpretation [see Clinical Studies (14)]. Image interpretation should be performed independently of the patient's clinical information. The use of clinical information in the interpretation of Neuraceq images has not been evaluated and may lead to errors. Errors may also occur in cases with severe brain atrophy that limits the ability to distinguish gray and white matter on the Neuraceq scan. Errors may also occur due to motion artifacts that result in image distortion.
*The person counts, not the gender! Life Molecular Imaging is committed to diversity, rejects discrimination, and does not think in categories such as gender, ethnic origin, religion, disability, age, or sexual identity. Life Molecular Imaging GmbH is an Equal Opportunity Employer. We believe what we do and our culture of "More Than a Job. It's Making Life Better" extends to creating a welcoming, safe, and inclusive work environment.
If you want to become part of an entrepreneurial team, if you are prepared to assume a wide range of responsibilities, and if your background and personal experience fit this profile, we invite you to apply. Don't forget to include a cover letter detailing your interest in this position and your past relevant work experience as well as a CV.
Dr. Andrew Stephens
Life Molecular Imaging GmbH Tegeler Str. 6-7
13353 Berlin
We are currently accepting applications and look forward to receiving yours.
Prior to Neuraceq administration, please read the fullPrescribing Informationfor additional Important Safety Inform ation.**
SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program
Published | 3 days ago |
Expires | in 27 days |
Work mode | Full Time |
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