Clinical Development Director
3 settimane fa
Pls 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. 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 Responsibilities Lead, 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 Education Educational Qualifications: MD / MS MD Internal and Pulmonary / Critical Care Medicine Experience Minimum 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 Development Scientific advocacy with policymakers / regulators Behavioural Attributes The incumbent should be good at decision-making and influencing the team. Should have good Interpersonal skills. #J-18808-Ljbffr
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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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Clinical Development Director Cns
2 settimane fa
Milano, Italia Barrington James A tempo pienoMy client is a CNS Drug Development specialist, focused on the development of novel therapies for patients with diseases of the central nervous system (CNS) and pain. I am exclusively partnered with this company to search for a Clinical Director to plan and execute clinical trials in CNS on a global scale. The position reports to the VP Clinical Operations...
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Clinical Development Director
3 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....
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Director, Clinical Development Scientist
2 settimane fa
Milano, Italia Altro A tempo pienoDirector, Clinical Development Scientist (Non-MD)Job SummaryAccountable for the scientific integrity of clinical studies and the well-being of patients enrolled in one or more clinical trials. Applies technical and clinical skills to design efficient, high-quality trials using quantitative principles and best clinical practices.Responsible for effective...
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Milano, Italia Sobi A tempo pienoJob Description Including, but not limited to the following: Shape and develop the clinical development plans, while adhering to the highest scientific and ethical standards Design, conduct and report Sobi-sponsored studies in close collaboration with the rest of the clinical development team, the clinical study teams, regulatory, safety and other...
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Medical Sciences Director
3 settimane fa
Milano, Italia Advanced Clinical A tempo pienoClinical Trial Educator – Europe Location: Remote, Europe Industry: Biopharmaceutical / Clinical Development Therapy Area: Rare disease About the Role We are seeking an experienced Clinical Trial Educator (CTE) to support clinical development programs across Europe. This position offers the opportunity to work directly with leading investigators and study...
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Clinical Development Medical Director
3 settimane fa
Milano, Italia Whatjobs A tempo pienoRole 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. Discussions with global regulators on respiratory clinical...
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Director, Business Development
2 settimane fa
Via Milano, Italia Caidya A tempo pienoJob Title Director, Business Development - CRO Services Job Location Milan, Italy (Home based - any Italian location considered) Job Overview Are you a business development professional with real experience in clinical research and pharmaceutical services? Do you enjoy a challenge and take pride in building lasting relationships that make a difference? As...
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Milano, Italia IQVIA A tempo pienoA leading global provider of clinical research services is seeking a Medical Director – Neurology to provide medical and scientific advisory expertise across divisions. The role involves serving as a Global Medical Advisor, developing strategies for clinical studies, and providing guidance to project leaders. The ideal candidate is required to have a...
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Global Development Scientist Associate Director
1 giorno fa
Milano, Italia AstraZeneca A tempo pieno**_Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science._** **About AstraZeneca** AstraZeneca is a global, science-led,...
