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.
To coordinate our sponsored studies and investigator sponsored studies/ research collaborations we offer the following full-time position located in our headquarter in Berlin, Germany, *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.
Ihre Aufgaben
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Support for the development and implementation of the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s) and participate in the design, development and conduct of clinical studies in cardiovascular indications.
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Project management and oversight of LMI sponsored studies according to GCP guidelines.
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Communication with study centers and CROs
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Preparation of study plans, clinical study reports and scientific publications
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For LMI's Investigator sponsored studies and research collaboration activities:
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Contribute to assessment and review of received study proposals.
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Managing research collaborations.
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Support data analysis, publications and scientific presentations as required.
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Interaction with the other Clinical Science Team members, Regulatory Affairs and other internal partners/stakeholders in the completion and submission of regulatory filings and other regulatory documentation.
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Support of data management activities for LMI sponsored studies.
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Organization of project team meetings., 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. 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.
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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:
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The most commonly reported adverse reactions in clinical trials were injection site pain (3.4%), injection/appliucation site erythema (1.7%), injection site irritation (1.1%).
DRUG INTERACTIONS
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Drug-drug interaction studies have not been performed in patients to establish the extent, if any, to which concomitant medications may alter Neuraceq image results.
Ihr Profil
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Ability to work effectively in a team environment
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Excellent communication skills
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Attention to detail and quality orientation
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Excellent organizational and time management skills
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Open-minded and motivating attitude
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Intercultural empathy
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MS Office skills, especially Word, Excel, and Project
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Fluency in English, written and spoken
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Proven scientific writing skills,
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Advanced degree (e. g. MD, PhD, PharmD) in Life Sciences
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Work experience in either research or clinical environment and in project coordination
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Relevant experience with CROs or in the pharma industry
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Ideally experience in cardiology or cardiovascular research
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Experience in medical imaging preferable
Our ideal candidate, based in Berlin or Brandenburg, would be able to work from our Berlin office approximately 40% of the weekly working time.
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 and a CV.
Kontakt
SUSPECTED ADVERSE REACTIONS please report to: https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program