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Demonstrated experience with the legal, regulatory and technical issues related to the ad tech industry and emerging technologies or privacy issues including iOT, AI and biometrics. Strong familiarity with the relevant legal and regulatory landscape in this area is required, as well as experience in providing counsel on U.S. and international data privacy and information security laws.
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We are seeking a Sr. Manager or Associate Director of statistical programming to join our rapidly growing biometrics team to support clinical studies across Arrowhead’s expanding portfolio. As an internal expert in statistical programming, you will provide technical leadership and statistical programming input to closely collaborate with other functional teams at Arrowhead, including Clinical Development and Operations, Regulatory, Data Management, Medical Affairs, Program Management and others.
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The Associate Director, Clinical Pharmacology, will be responsible and accountable to lead and execute clinical pharmacology strategies and activities for assigned programs and studies from early through late-stage clinical development and approval, including post marketing activities, and collaborate cross-functional stakeholders including research, DMPK, translational medicine, clinical development, clinical operation, biometrics, regulatory, CMC, and project management.
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In this role, the GRS-CMC Director, Cell Therapy will serve as the primary interface between Global Regulatory Sciences and Biometrics (GRSB) & Cell Therapy Development Operations (CTDO.
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Additionally, the role involves representing the organization in interactions with regulatory agencies, fostering a culture of excellence and continuous improvement within the Global Biometrics and Data Sciences, and serving as a thought leader in the field of real-world evidence.
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This key leadership position involves providing guidance and expertise in statistical methodologies, study design using real-world data to facilitate and support development and regulatory interactions of pharmaceutical products.
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Interact with regulatory agencies, in concert with the Regulatory Affairs Department, to develop novel and efficient clinical programs in both rare and common disease populations. Reviewing clinical study data and performing analyses in conjunction with Biometrics.
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The incumbent will collaborate with all the groups involved in Clinical Development e.g., Clinical Pharmacology (CP), Clinical Operations, Biometrics, Pharmacovigilance, Regulatory Affairs, HEOR and Medical Affairs.
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Job DescriptionDirector, Global Regulatory Sciences - CMC - Cell TherapyDivision Research and Development / Global Regulatory, Safety and Biometrics / Global Regulatory Sciences - Chemistry Manufacturing and Controls (GRS-CMC)Functional Area DescriptionThe GRS-CMC organization provides regulatory expertise related to CMC activities through all stages of a products lifecycle.
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Oversee the execution of histopathology strategies and deliver biomarker results to internal and external stakeholders while working collaboratively with Translational Biomarker Leads, Biology, Clinical Science, Biometrics, Bioinformatics, Clinical/Biomarker Operations, and others.
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Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.
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Managers of Statistical programming provide comprehensive programming expertise to clinical project teams to support the development, regulatory approval and market acceptance of Bristol Myers Squibb (BMS) products.
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A minimum of 5 years of clinical/statistical programming experience within pharmaceutical clinical development, supporting regulatory filings (e.g. NDA, BLA, MAA). Managers of Statistical Programming develop collaborative relationships and work effectively within Global Biometrics & Data Sciences (GBDS), with external vendors and members of cross-functional development teams.
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Ensures successful management and coordination of efforts assigned to all members of the project team, including but not limited to Pre-clinical development, toxicology, DMPK, CMC, Regulatory, and Clinical Operations, Biometrics, and Medical Affairs/Safety, to support milestone achievement and overall project delivery.
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The Senior Clinical Trials Manager provides oversight of the CRO and other third-party vendors on their assigned study as well as expertise to internal teams (regulatory affairs, medical writing, biometrics, pharmacovigilance, and product manufacturing) to ensure quality processes and deliverables.
$155,000 - $165,000 a yearFull-timeExpandApply NowActive JobUpdated 2 months ago
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