Clinical Development Director
7 giorni fa
Pls note: Incumbent can be based anywhere in Europe or the US.Role OverviewThis position is intended to head and support the clinical development of new drugs conception of innovative approaches to plan clinical studies and support end to end drug development in accordance with all applicable regulations and align them with company's business objectives.Discussions with global regulators on respiratory clinical development pathways for facilitation of drug approvals.Review & due diligence of in-licensing respiratory molecules.Presentation in ad boards and global respiratory meetings.Job ResponsibilitiesLead, manage and mentor Clinical Sciences respiratory projects and ensure timely delivery of all deliverables. The responsibilities of the Glenmark Medical Monitor may include but is not limited to the following.Contribute and/or provide review to key study related documents such as protocols, informed consents and amendments, eCRFs, SAP, MMP, SMP, and TLFs.Review of CRO medical monitoring capabilities as part of study start up and RFP process including the CRO MM CVs, MMP, and investigator / site lists as part of the vendor selection process or final CRO determination.Provide guidance on subject eligibility, deviations, and other medical, safety, or protocol related questions to CRO MM, site investigators, and CRO and Sponsor study team.Review of blinded efficacy and safety data, listings, tables, deviations, and provide supportive review of blinded SAE or SUSAR related documents and address or escalates any data that might impact subject safety or study integrity.Attendance during internal or joint CRO-sponsor medical monitoring safety meetings and review of medical meeting minutes.Review of blinded medical coding for AEs, SAEs, prior and concomitant medications, and medical history, and participate in BDRM prior to DBL and provide primary interpretation of efficacy and safety after unblinding.Support Business development for respiratory programs and portfolio, med affairs in BD and ROW development including new and lifecycle management programs.Build and maintain close collaboration with internal stakeholders (Preclinical Research, Toxicology, DMPK, Regulatory, ClinOps, Project Management, Medical Affairs, legal and others). Participate in ad boards, respiratory forums, presentations in respiratory meetings. Discussions with regulators on clinical development pathways and faster approvals.Development of projects and evaluation of new business opportunities or internal Target Drug Candidates for expansion of respiratory, allergy, and inflammation pipeline and business growth. Drive the overall strategy and delivery of respiratory programs from clinical candidate evaluation and selection up to Registration.Knowledge and EducationEducational Qualifications:MD / MSMD Internal and Pulmonary / Critical Care MedicineExperienceMinimum 18 years experience as a practicing pulmonary clinical professional.5 years experience in the pharmaceutical industry / clinical projects in clinical development.Regulatory interactions for drug development.Knowledge and Skills (Functional / Technical)Drug DevelopmentScientific advocacy with policymakers / regulatorsBehavioural AttributesThe incumbent should be good at decision-making and influencing the team. Should have good Interpersonal skills.#J-*****-Ljbffr
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(Senior) Director Clinical Development
1 settimana fa
Milano, Italia Sobi A tempo pienoThe (Senior) Director Clinical Development is responsible forshaping, developing and executing the clinical development strategyfor the assigned product.Specific responsibilities include:design of clinical trials(any phase as required by the clinical development program, including phase IV), clinical protocol development, medical monitoring of clinical...
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(Senior) Director Clinical Development
12 ore fa
Milano, Italia Hitachi Rail A tempo pienoEUR 100.000 - 140.000 3 giorni fa Company Description (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study...
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(Senior) Director Clinical Development
4 giorni fa
Milano, Italia Sobi - Swedish Orphan Biovitrum AB (publ) A tempo pienoCompany Description (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers,...
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(Senior) Director Clinical Development
3 giorni fa
Milano, Italia Sobi - Swedish Orphan Biovitrum Ab (Publ) A tempo pienoCompany Description(Senior)Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product.Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers,...
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(Senior) Director Clinical Development
2 giorni fa
milano, Italia Sobi - Swedish Orphan Biovitrum AB (publ) A tempo pienoCompany Description(Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers,...
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(Senior) Director Clinical Development
2 giorni fa
Milano, Italia Sobi - Swedish Orphan Biovitrum AB (publ) A tempo pienoCompany Description (Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers,...
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milano, Italia Hitachi Rail A tempo pienoEUR 100.000 - giorni faCompany Description(Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and...
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(Senior) Director Clinical Development
10 ore fa
Via Milano, Italia Hitachi Rail A tempo pienoEUR 100.000 - giorni faCompany Description(Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and...
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(Senior) Director Clinical Development
2 giorni fa
Via Milano, Italia Sobi - Swedish Orphan Biovitrum AB (publ) A tempo pienoCompany Description(Senior) Director Clinical Development is responsible for shaping, developing and executing the clinical development strategy for the assigned product. Specific responsibilities include designing phase IV clinical trials, clinical protocol development, medical monitoring, data analysis, review of study reports and registration dossiers,...
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Clinical Development Director
4 settimane fa
Milano, Italia Whatjobs A tempo pienoPls note: Incumbent can be based anywhere in Europe or the US. Role Overview This position is intended to head and support the clinical development of new drugs conception of innovative approaches to plan clinical studies and support end to end drug development in accordance with all applicable regulations and align them with company's business objectives....
