- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... of clinical studies, review & interpretation of clinical trial data , authoring clinical ...A PhD in addition to the above10+ years of management experience in ophthalmology clinical development.Pediatric experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review Plan ... Director , Clinical Development Join a Legacy...Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility… more
- Merck & Co. (North Wales, PA)
- …control tools is required.-Basic knowledge of Site Monitoring, Study Start up, Data Management , Pharmacovigilance, Essential Document Management , and ... a premier research-intensive biopharmaceutical company. We are seeking an Associate Director , Clinical Systems Implementation to manage activities related to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in the assigned therapeutic area. Relationships Reports to the Executive Director - Clinical Research & Development. Internal relationships include working ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...with Headquarters, NA CMR including Clinical Trial Management , Medical Affairs, Regulatory Affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s), Clinical Safety ... post-doctoral fellows. Provides guidance, and mentors and coaches junior Clinical Safety Scientists.Responsibilities Risk Management (Signal identification,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure appropriate biomarker, PK / PD measurements; Reviews emerging clinical data regularly; Leads dose-escalation meetings; Performs quality assessment ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …TMCP to ensure appropriate biomarker, PK / PD measurements, Reviews emerging clinical data regularly, Leads dose-escalation meetings, Performs quality assessment ... plan by function and team; Interprets and react accordingly to new preclinical/ clinical data (eg; Go/No Go decisions, reprioritization, etc.); Operational Project… more
- Merck & Co. (San Francisco, CA)
- Job DescriptionRole SummaryThe Cardiovascular & Metabolism Regional Medical Scientific Director is a credentialed (ie, PhD, PharmD, DNP, MD) therapeutic and disease ... questions about Company products. The work of a Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Merck & Co. (Boston, MA)
- …in the assigned territory (Boston area).Role SummaryThe Oncology Regional Medical Scientific Director - Head & Neck Cancers/Melanoma is a credentialed (ie, PhD, ... questions about company products. The work of an Regional Medical Scientific Director is aligned to: Scientific Exchange, Research, Scientific Congress Support, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review- Conducts clinical data review per Integrated Data Review Plan- Accountable ... centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development,...Monitor (MM):- Provides oversight to the CRO MM for clinical data review activities- May support addressing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Merck & Co. (Rahway, NJ)
- …company is seeking a highly motivated candidate for the position of Director , Small Molecule Development within the Mixed Modalities, Sterile Product Development ... for parenteral drug products within the small molecule and synthetic modality pipeline.The Director will report to the Executive Director of Sterile Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …& category management required- CRO experience preferred- Strong knowledge of clinical trials preferred- Demonstrated ability to leverage digital data and ... plans for specific categories under the direction of the head of category management , for the creation, execution, tracking of strategies. Includes working under a… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …East Coast Development Hub. Key internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management , Biostatistics, ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Merck & Co. (Rahway, NJ)
- …Visualization, Machine Learning, Software Development, Stakeholder Relationship Management , Waterfall Project ManagementPreferred Skills:Job Posting End ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …Evidence lead and Global Disease Leads (GDLs), to develop view on minimum level of clinical data needed from interim or final analyses to inform Go To File ... Job DescriptionWe are currently recruiting for a Director , Global Oncology Market Access.The Director will be developing and executing the market access &… more
- Merck & Co. (Rahway, NJ)
- …or BS degree in relevant discipline.-Knowledge and Skills:--Minimum 6 years' experience in Clinical Data Management or Pharmacovigilance as appropriate to ... May support any other project or perform any other data management or drug surveillance task deemed...experience preferred, at least 3 years of supervisory or management experienceStrong knowledge of Clinical Development through… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …group and high-complexity disease work to support critical strategic choices for the clinical program. The DAST Director will collaborate with the DAST Lead ... to the disease strategy and the strategic choices for clinical development and data generation- Develop and...experience in project management or leading change management initiatives preferred- Prior experience in clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management , Regulatory Affairs, ... Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management , Quality Assurance, Medical Affairs, Translational Research, Research, Informatics… more
- Merck & Co. (Rahway, NJ)
- …updates.Supports device sites with the collection and analysis of data for management review. Reports to - Director Regulatory Compliance, Device Quality and ... Job DescriptionPosition Title - Director / Principal Scientist, Regulatory Compliance Department - Device...Quality & Regulatory Team within Global Regulatory Affairs and Clinical Safety (GRACS). The primary responsibility for this position… more
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