3 jobs found in Basel-Stadt

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    • basel, basel-stadt
    • contract
    Do you want to work in a big pharmaceutical company? Do you have experience in GCP and Pulmonary Hypertension Therapeutic Area or Cardiovascular/Cardiopulmonary? You should then read the following lines! Our client, based in Basel area, is looking for a Clinical Project Physician for a one year contract. The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management,medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area Essential Functions: Responsible for medical monitoring/reporting and company safety officer activitiesWorks on clinical development plans, trial protocols and takes ownership of clinical study reportsEvaluates adverse events (pre and post-marketing) for relationship to treatmentAssists Regulatory Affairs in determining requirements for any corrective actions or health authority reportingMay act as a medical contact at the company for health authorities concerning clinical/medical issuesInterprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissionsClose interactions with Project Scientists and Physicians across programs Other Responsibilities : Assists Regulatory Affairs in the development of drug regulatory strategiesHelps explore and evaluate new product ideas to assist in identifying new market opportunitiesSupport general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillanceParticipate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.Reviews medical literature and related new technologiesMay be asked to assess medical publications emerging from the Team and its affiliatesMay be responsible, with appropriate colleagues, for review of Company advertising and promotional materials Candidate Profile: MD (or equivalent) in relevant area with appropriate post-doctoral training and certificationExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filingsSpecific experience in phase II and III studies is a strong advantage.Submission experience a strong advantage.Experience in medical review.Ideally previous experience in the Pulmonary Hypertension Therapeutic Area, otherwise Cardiovascular/Cardiopulmonary experience is appreciated.English Fluent Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    Do you want to work in a big pharmaceutical company? Do you have experience in GCP and Pulmonary Hypertension Therapeutic Area or Cardiovascular/Cardiopulmonary? You should then read the following lines! Our client, based in Basel area, is looking for a Clinical Project Physician for a one year contract. The Project Physician is a responsible member of a clinical team dedicated to the development and execution of medical strategies and the clinical and operational implementation of a complex compound program. The Project Physician provides active medical and scientific contribution to a cross-functional clinical team. The Project Physician provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes ownership for the content of clinical study reports and relevant documents for regulatory filings. Team matrix interactions include project management, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, TA strategy, regulatory affairs, data management,medical writing, biostatistics, global medical affairs, clinical pharmacology, clinical operations, health economics, epidemiology and other scientific and business related disciplines. The Project Physician may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area Essential Functions: Responsible for medical monitoring/reporting and company safety officer activitiesWorks on clinical development plans, trial protocols and takes ownership of clinical study reportsEvaluates adverse events (pre and post-marketing) for relationship to treatmentAssists Regulatory Affairs in determining requirements for any corrective actions or health authority reportingMay act as a medical contact at the company for health authorities concerning clinical/medical issuesInterprets, reports and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissionsClose interactions with Project Scientists and Physicians across programs Other Responsibilities : Assists Regulatory Affairs in the development of drug regulatory strategiesHelps explore and evaluate new product ideas to assist in identifying new market opportunitiesSupport general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillanceParticipate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.Reviews medical literature and related new technologiesMay be asked to assess medical publications emerging from the Team and its affiliatesMay be responsible, with appropriate colleagues, for review of Company advertising and promotional materials Candidate Profile: MD (or equivalent) in relevant area with appropriate post-doctoral training and certificationExperience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filingsSpecific experience in phase II and III studies is a strong advantage.Submission experience a strong advantage.Experience in medical review.Ideally previous experience in the Pulmonary Hypertension Therapeutic Area, otherwise Cardiovascular/Cardiopulmonary experience is appreciated.English Fluent Do not waste any minutes, apply now!  We are looking forward to receiving your application.Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered.
    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    For our client, a pharmaceutical company in the Basel area we are looking for anBioanalytical Manager Start date: middle May 2021, latest August 2021End date:18 monthsExtension: possibleWork location: BaselRemote/Home Office: home office at the momentBackground:This position will be focused on external CRO management. The successful candidate will look after studies done externally from a bioanalytical point of view (e.g measuring blood & tissue concentration in both humans & animals). This will be on both small and large molecules.Tasks & Responsibilities:Lead bioanalytical strategies to generate decision-enabling bioanalytical data with skilled data interpretation to meet and answer project needsResponsible for outsourcing activities in Bioanalytics (bioanalysis of non-clinical and clinical studies); resource and time planning, coordination and administrative management of studies with CROs.Manage the development, transfer and validation of specific and sensitive bioanalytical methods required for the development compound (drug), anti-drug antibodies (ADA), soluble targets and any concomitant/interaction compound in the given project.Manage and direct analysis of samples and timeline from preclinical and clinical studies for the project at CRO labs.Participate actively in PS subteams, act as primary contact person for DMPK project leader.Act as Bioanalytical Leader when required. Interact proactively with the assay development team.Ensure full compliance with the current global and local bioanalytical guidance and GxPs.Leadership in Bioanalysis: *remain current and continually develop expertise in bioanalytical science. Contribute to scientific consortia when required; *maintain current expertise in the validation and conduct of bioanalytical assays; *guide and manage the bioanalysis at CROs and ensure that most advanced and most efficient procedures are used.Provide technical leadership in issue resolution.Review protocols and other relevant documents and guide project teams in all aspects of bioanalytical work required for the project.Review and write reports for regulatory submissions; support filings and answer any questions about bioanalytics coming from the regulatory agencies.Maintain open links with other disciplines within the department and the organization.Advise Group Head concerning all needs relating to administrative processes, technologies and equipment. Inform him of all critical issuesMust haves:Minimum 3 years in a similar position focused on bioanalysis in pharma or CRO (pharma preferred) OR scientist focused on bioanalysisExcellent work experience on both large and small molecules bioanalysis (preferred and will receive 5 stars) IF not both, either large or smallStrong vendor management experience, looking after outsourced studies to external CROs (*****)Degree in biology/biochemistry (*****)
    • basel, basel-stadt
    • contract
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.
    For our client, a pharmaceutical company in Basel we are looking for aClinical Trial LeaderStart date: asapEnd date: 31.12.2022Extension: possibleWork location: BaselWorkload: 100%Responsible for the management and clinical execution of assigned clinical trials within Translational Medicine (TM). Functions as the CTL on the planning and implementation of all operational aspects of assigned TM clinical trials from study concept to reporting according to timelines, budget, operational and quality standards (ICH/GCP/Novartis SOPs and procedures).Tasks & Responsibilities:Function as Clinical Trial Leader for assigned studies (scientific and/or operational complexity) including multi-country / multi-center trials. The main focus will be de- pendent on department workload and need).Responsible for leading and matrix managing the multidisciplinary CTT and support functions to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practicesAuthor of the clinical study protocol and other study essential documents.Responsible for ordering and management of clinical trial materials, including drug supplies and CRFs.In collaboration with outsourcing/planning/feasibility personnel, CTT, Local CPO representatives and CRAs, identify sites and manage study set-up, including responsibility for organizing and chairing the Investigator meeting(s) (as appropriate), and/or Site Initiation meeting(s).Train and support the CRA(s)/CRO(s) on study protocol and related questions and serve as point of contact for managing/answering questions relating to trial procedures and subjects’ eligibility.Ensure the set up and maintenance of the Trial Master File for assigned studies, ensuring all relevant study documents are filed and archived at the end of the study according to the appropriate guidelines.Interact with Investigator sites and CRAs/CROs/vendors to ensure smooth study set up and excellence of study conduct, reviewing site performance, protocol deviations, and maintaining awareness of issues raised.Assist in data review and interactions with the Data Manager, Statistician, and third parties (e.g. outsourced data management or data vendors) to ensure high-quality data are transferred/available in a timely manner.Responsible for report writing of assigned studies either directly contributing to and managing the report writing or liaising with the medical writing/narrative group to ensure the report is completed according to current requirement. Responsible for report publication.In collaboration with the Medical Expert and CTT, coordinate the ongoing medical/scientific review of the clinical trial data (as needed), and coordinate the data analysis and interpretation including the development of first interpretable results, the clinical study report, publications and internal/external presentations. May support the Medical Expert on project documentation e.g. Briefing books, IBs, Annual Safety Reports, responses to Health Authority questions, etc.Ensure a complete review is conducted of all study documentation within the assigned studies/project at the end of each study, with all essential documents appropriately archived and paper Trial Master Files physically transferred to the central archive.Responsible for the coordination of pre-audit activities for nominated projects ensuring a satisfactory outcome is achieved, and address corrective actions.Oversee the work of assigned support CTL(s), ensuring clear delegation/assignment of duties are documented.Contribute to the identification and evaluation of new clinical sites as appropriate for assigned studies.Provide CS&I expert advice to other departments and line functions (e.g. CQA, Drug Metabolism and Pharmacokinetics (DMPK), Drug Supply Management (DSM) as applicable to assigned studies.Must-haves:BSc or MSc in life sciences or nursing; a Ph.D. level scientist with life sciences background; PharmD or equivalent qualification or work experience.Relevant experience (5+ years) in clinical trial management (e.g. study management in a multi-national environment using different models for trial execution).Demonstrated leadership and problem-solving skills.Track record of managing multiple, complex clinical trials.Capable of clear written and verbal expression of ideas, an active/proactive communicator.Ability to interact with a wide range of people and build strong positive relationships.Potential for customer orientation awareness and focus.Excellent organizational skills and interpersonal skills.Ability to work independently and in a team environment managing multiple priorities.

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