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24 Treffer für Clinical Expert Jobs in München im Umkreis von 30 km
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Schnelle Bewerbung
We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. The successful candidate should not only understand clinical pharmacology, DMPK, PopPK, PBPK, PK/PD, ADME, and safety data, but also be able to interpret these data critically and translate them into clear development decisions. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under real-world constraints of time, budget, regulatory risk, and clinical feasibility. • Lead HMNC's clinical pharmacology and DMPK strategy across pipeline programs, ensuring alignment with clinical ...
We are seeking a senior Clinical Pharmacology expert who can combine deep pharmaceutical industry experience with a strong understanding of regulatory authority expectations. HMNC Brain Health (HMNC) is a clinical-stage neuroscience company pioneering new therapies for mental health disorders. The successful candidate should not only understand clinical pharmacology, DMPK, PopPK, PBPK, PK/PD, ADME, and safety data, but also be able to interpret these data critically and translate them into clear development decisions. The role requires someone who has worked in or closely with the pharmaceutical industry and understands how development decisions are made under real-world constraints of time, budget, regulatory risk, and clinical feasibility. • Lead HMNC's clinical pharmacology and DMPK strategy across pipeline programs, ensuring alignment with clinical ...
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Schnelle Bewerbung
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research - You will contribute to statistical activities related to global clinical trials and work closely with international teams of , and , including the role of biostatistics project lead * Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis * Expert knowledge and understanding of the SAS programming * Expert knowledge and understanding of CDISC ADaM standard * Expert knowledge and understanding of adaptive designs * Expert knowledge and understanding of sample size calculation * Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) * Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, ...
Expert knowledge and understanding of the statistical principles, concepts, methods, and standards used in clinical research - You will contribute to statistical activities related to global clinical trials and work closely with international teams of , and , including the role of biostatistics project lead * Conduct statistical analysis for clinical trials including, interim analysis, final analysis, analysis for DSMBs/DMCs and PK analysis * Expert knowledge and understanding of the SAS programming * Expert knowledge and understanding of CDISC ADaM standard * Expert knowledge and understanding of adaptive designs * Expert knowledge and understanding of sample size calculation * Expert knowledge and understanding of relevant regulations and guidelines (e.g. FDA, EMA, ICH) * Ability to apply advanced statistical techniques in support of clinical research studies and to analyze, interpret, ...
Noch nichts dabei? Es gibt 22 weitere Jobs, die zu deiner Suche passen könnten
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Clinician for the Clinical Centre of Excellence (f/m/d)
Clinician for the Clinical Centre of Excellence (f/m/d)
TÜV SÜD
München, Ahmedabad, Madrid, Lissabon, Warschau
Teilweise Home-Office
Optionally providing support during audits of clinical processes of as a clinial expert (remote or on-site) * Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR) * Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support and close exchange with colleagues * Four years of clinical practice in health care services or related sectors in the area of Cardiac surgery * Two years of experience in usage, development or testing/evaluation of medical devices or clinical studies/investigations or clinical evaluation of medical devices * Experience with MDR, regulatory aspects of medical devices, clinical evaluation for medical devices / medical writing is a plus.
Optionally providing support during audits of clinical processes of as a clinial expert (remote or on-site) * Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR) * Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support and close exchange with colleagues * Four years of clinical practice in health care services or related sectors in the area of Cardiac surgery * Two years of experience in usage, development or testing/evaluation of medical devices or clinical studies/investigations or clinical evaluation of medical devices * Experience with MDR, regulatory aspects of medical devices, clinical evaluation for medical devices / medical writing is a plus.
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Head of Medical Safety GCSP (m/f/d)
Head of Medical Safety GCSP (m/f/d)
Bavarian Nordic GmbH
Martinsried bei München, Bern
Teilweise Home-Office
We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). As our Head of Medical Safety GCSP, you will be accountable for all medical safety related aspects of clinical safety and pharmacovigilance as well as ad hoc safety issues and innovation projects in your area of expertise. * Ensure high-quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, BN operating procedures (SOPs) To succeed in this role, you must have a medical doctorate (MD) and leadership experience in clinical safety and pharmacovigilance. * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - You have solid knowledge of global clinical safety and pharmacovigilance ...
We are looking for an experienced Head of Medical Safety GCSP providing medical leadership across Global Clinical Safety & Pharmacovigilance (GCSP). As our Head of Medical Safety GCSP, you will be accountable for all medical safety related aspects of clinical safety and pharmacovigilance as well as ad hoc safety issues and innovation projects in your area of expertise. * Ensure high-quality clinical safety contributions to development programs and for the life-cycle management of marketed products in compliance with regulations, guidelines, BN operating procedures (SOPs) To succeed in this role, you must have a medical doctorate (MD) and leadership experience in clinical safety and pharmacovigilance. * 10+ years of experience in clinical safety and pharmacovigilance, including senior medical safety role - You have solid knowledge of global clinical safety and pharmacovigilance ...
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Senior Clinical Research Associate (w/m/d) - sponsor dedicated - home based
Senior Clinical Research Associate (w/m/d) - sponsor dedicated - home based
Fortrea Germany GmbH
München
Teilweise Home-Office
Mitarbeit in kundenspezifischen Arbeitsgruppen und anderen internen Projekten als Subject Matter Expert
Mitarbeit in kundenspezifischen Arbeitsgruppen und anderen internen Projekten als Subject Matter Expert
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Domain-naher QA-Experte - Life Sciences (m/w/d)
Domain-naher QA-Experte - Life Sciences (m/w/d)
SPIRIT-TESTING Software & Services GmbH
München
Teilweise Home-Office
Clinical Operations
Clinical Operations
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The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will oversee and mentor junior Clinical and as needed. * Previous experience in clinical research (in CROs, Pharma or academy/hospital experience) * Good knowledge of Clinical Research and Regulatory/Ethical requirements
The Senior Clinical Trial Coordinator assists the clinical research team to ensure that the study is conducted in accordance with GCP, all relevant SOPs, the protocol and in respect of the budget and timelines. They will oversee and mentor junior Clinical and as needed. * Previous experience in clinical research (in CROs, Pharma or academy/hospital experience) * Good knowledge of Clinical Research and Regulatory/Ethical requirements
The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. * Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials; as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with US: Director of Clinical Monitoring, Lead CRAs, in-house CRAs, EU: Associate Director of Clinical Monitoring, CRAs, and Project Managers to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. * Coordinates with appropriate cross-functional departments to facilitate negotiation/issue resolution for clinical trial monitoring related issues. * Collaborates with development and maintenance of Clinical Trial Management System (CTMS).
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We work at the intersection of artificial intelligence, hardware, software, and clinical innovation, building products that enhance diagnostic precision and improve patient outcomes. We are an ambitious, international team of around 20 people that moves fast, learns constantly, and develops AI-driven technologies to support surgeons in some of the most demanding clinical environments.
We work at the intersection of artificial intelligence, hardware, software, and clinical innovation, building products that enhance diagnostic precision and improve patient outcomes. We are an ambitious, international team of around 20 people that moves fast, learns constantly, and develops AI-driven technologies to support surgeons in some of the most demanding clinical environments.
Schnelle Bewerbung
Plan and execute digital campaigns across Google Ads, Meta, and LinkedIn — targeting surgeons, residents, and clinical decision-makers * Direct exposure to the medtech world: clinical content, surgical audiences, global congresses
Plan and execute digital campaigns across Google Ads, Meta, and LinkedIn — targeting surgeons, residents, and clinical decision-makers * Direct exposure to the medtech world: clinical content, surgical audiences, global congresses
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Act as trusted scientific expert, delivering accurate and compliant medical science and clinical education to external stakeholders. Develop relationships with HCPs and clinical sites to support effective product evaluations, case studies, and long-term adoption. * Deliver tailored educational programs to HCPs, ensuring dissemination of our latest scientific and clinical evidence. * Collaborate with established and emerging KOLs on clinical evidence generation to validate our products. * Proactively engage KOL networks to gather insights, inform clinical practice, and support the adoption of our innovative solutions. * Collect product performance and user feedback for Research & Development (R&D), Medical & Clinical Affairs (MACA), and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies.
Act as trusted scientific expert, delivering accurate and compliant medical science and clinical education to external stakeholders. Develop relationships with HCPs and clinical sites to support effective product evaluations, case studies, and long-term adoption. * Deliver tailored educational programs to HCPs, ensuring dissemination of our latest scientific and clinical evidence. * Collaborate with established and emerging KOLs on clinical evidence generation to validate our products. * Proactively engage KOL networks to gather insights, inform clinical practice, and support the adoption of our innovative solutions. * Collect product performance and user feedback for Research & Development (R&D), Medical & Clinical Affairs (MACA), and commercial teams to inform life cycle management, next-generation innovations, clinical study designs, and commercial strategies.
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Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards. * Provide expert advice to corporate functions on drug safety requirements and best practices.
Partner across Patient Safety to drive compliance for post-marketing and clinical trial safety activities and uphold company policies and standards. * Provide expert advice to corporate functions on drug safety requirements and best practices.
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Gesundheits- und Krankenpfleger in der Gesundheitsberatung (m/w/d)
Gesundheits- und Krankenpfleger in der Gesundheitsberatung (m/w/d)
SHL Telemedizin GmbH
München
Teilweise Home-Office
Du bist sicher im Umgang mit digitalen Tools (MS Office, idealerweise Clinical Portals) und besitzt eine hohe Technikaffinität
Du bist sicher im Umgang mit digitalen Tools (MS Office, idealerweise Clinical Portals) und besitzt eine hohe Technikaffinität
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Associate Director (m/f/d), Computational Pathology Biomarker Lead (Oncology/BioPharma)
Associate Director (m/f/d), Computational Pathology Biomarker Lead (Oncology/BioPharma)
AstraZeneca
München
Do you thrive at the intersection of AI innovation and clinical translation? In this position you will work with a multi-disciplinary team to pioneer AI-enabled computational pathology and multi-modal biomarkers that fundamentally change how we approach patient selection and drug development, aiming to improve clinical outcomes. Within AI for Computational Pathology and Biomarkers, we're pioneering AI-powered solutions that transform patient selection, biomarker development, and clinical decision-making at enterprise scale. * Provide scientific leadership for AI-powered computational pathology and multimodal biomarker development across AstraZeneca's Oncology and/or BioPharmaceuticals portfolio, delivering biomarkers that support patient selection and translational decision-making from target validation through clinical development.
Do you thrive at the intersection of AI innovation and clinical translation? In this position you will work with a multi-disciplinary team to pioneer AI-enabled computational pathology and multi-modal biomarkers that fundamentally change how we approach patient selection and drug development, aiming to improve clinical outcomes. Within AI for Computational Pathology and Biomarkers, we're pioneering AI-powered solutions that transform patient selection, biomarker development, and clinical decision-making at enterprise scale. * Provide scientific leadership for AI-powered computational pathology and multimodal biomarker development across AstraZeneca's Oncology and/or BioPharmaceuticals portfolio, delivering biomarkers that support patient selection and translational decision-making from target validation through clinical development.
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Senior Scientist Drug Product Process Development (gn) 2-Year Fixed-Term Contract
Senior Scientist Drug Product Process Development (gn) 2-Year Fixed-Term Contract
Formycon AG
Planegg
Teilweise Home-Office
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
Director (gn) Business Development - Licensing & Alliance Management
Director (gn) Business Development - Licensing & Alliance Management
Formycon AG
Planegg
Teilweise Home-Office
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
With an experienced team comprised of around 200 highly skilled professionals, the company is able to span the entire value chain of biosimilar drug development, from market analysis and target definition by protein analytics, to the development of production processes, to clinical trials and the regulatory approval process.
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Schnelle Bewerbung
Some of the key tasks you will be involved with are:- Supporting in the preparation and execution of clinical trials - Procurement of study materials and office supplies
Some of the key tasks you will be involved with are:- Supporting in the preparation and execution of clinical trials - Procurement of study materials and office supplies
The Study Start Up (SSU) Associate function is to support the with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements. * Submission of the clinical study agreement for review, as needed. * Clinical Trial Health Authority application and regulatory submission process. * Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities. * Prior work experience demonstrating knowledge and understanding of clinical trials. * Demonstrated knowledge and understanding of ICH-GCP and a desire to increase specialist knowledge in regulatory, ethics and contractual requirements for SSU in clinical trials for European and international trials.
The Study Start Up (SSU) Associate function is to support the with all SSU-related activities in collaboration with other clinical research stakeholders and to serve as a contact for local/global SSU process improvements. * Submission of the clinical study agreement for review, as needed. * Clinical Trial Health Authority application and regulatory submission process. * Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities. * Prior work experience demonstrating knowledge and understanding of clinical trials. * Demonstrated knowledge and understanding of ICH-GCP and a desire to increase specialist knowledge in regulatory, ethics and contractual requirements for SSU in clinical trials for European and international trials.
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Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany
Schnelle Bewerbung
The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
The Country Study Manager (CSM) has local responsibility for the delivery of the studies in compliance with Good Clinical Practice (GCP), and regulatory requirements. The CSM works in close collaboration with Study Start-Up (SSU) manager, Clinical Study Administrator (CSA) and other CRAs in Country Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner in the country level. The CSM is responsible for ensuring that all requirements for site activation are in place for the agreed number of centers in clinical studies according to SOPs. * Reviewing Clinical Monitoring Documentation (reports, metrics, etc) for the assigned studies. * Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Clinical Monitoring Plan (CMP).
The Vice President, Monitoring and Site Engagement is a key member of the Alira Health Clinical leadership team. In this role, the VP oversees the Directors of Clinical Monitoring in Europe and North America, ensuring operational excellence across all monitoring activities and the consistent delivery of high‑quality outcomes to sponsors while meeting expectations, timelines, and regulatory standards. * Serves as a leader, point of mentorship, and point of escalation for the DirectorsDirectors of Clinical Monitoring, and Director(s) of Study Start Up. * Develops and maintains, together with the local Alira Health teams and local CRO partners as applicable, a network of existing and potential clinical study sites across all regions, and facilitates partnership with institutions to build a framework of collaboration.
The Vice President, Monitoring and Site Engagement is a key member of the Alira Health Clinical leadership team. In this role, the VP oversees the Directors of Clinical Monitoring in Europe and North America, ensuring operational excellence across all monitoring activities and the consistent delivery of high‑quality outcomes to sponsors while meeting expectations, timelines, and regulatory standards. * Serves as a leader, point of mentorship, and point of escalation for the DirectorsDirectors of Clinical Monitoring, and Director(s) of Study Start Up. * Develops and maintains, together with the local Alira Health teams and local CRO partners as applicable, a network of existing and potential clinical study sites across all regions, and facilitates partnership with institutions to build a framework of collaboration.
Schnelle Bewerbung
Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company. * Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area.
Development and implementation of the local medical strategy to support clinical practice and the objectives of the overall company. * Responsibility for the implementation of new medical practices, the evaluation of new indications, analysis of the status quo of current treatment and patient pathways, identification of patients for clinical research, and the development of a deep understanding of the respective indication area.
Schnelle Bewerbung
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany
Conceptualize and coordinate engagement of PAOs in clinical development programs running and/or planned in Germany
12 passende Jobs liegen außerhalb deiner Region
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Head of New Technology Formulation (m/w/d) Design/Process Development
Head of New Technology Formulation (m/w/d) Design/Process Development
Daiichi Sankyo Europe GmbH
Pfaffenhofen an der Ilm
Support and prepare regulatory submissions for clinical development, NDA, and BLA applications.
Support and prepare regulatory submissions for clinical development, NDA, and BLA applications.