- Genmab (Plainsboro, NJ)
- …our purpose.Genmab is looking for a dynamic, science-driven people leader to head our Clinical Pharmacology & Quantitative Sciences team. Do you get excited by ... powerhouse. The RoleYou will act as functional leader of our Clinical Pharmacology & Quantitative Sciences (CPQS) group, currently consisting of 25+ scientists.… more
- Merck & Co. (South San Francisco, CA)
- …writer to join our team in South San Francisco, CA.The nonclinical pharmacology writing group prepares reports and submission modules to support development ... for FIH through licensure. The role involves verifying data, writing pharmacology study reports, written summaries, and related documents, managing author/management… more
- Merck & Co. (Rahway, NJ)
- … Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to ... clinical trial simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities… more
- Merck & Co. (Rahway, NJ)
- … Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to ... We are seeking an experienced talented scientist to join the - Quantitative Pharmacology and Pharmacometrics - - Immune/Oncology - (QP2-IO) - team in the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …industry, regulatory agency or academia, with exposure to drug development, clinical pharmacology , and/or epidemiology required.Must have expertise in global ... a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology , and other… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …responses to IRBs and Health Authorities; Collaborates with Translational Medicine and Clinical Pharmacology to ensure appropriate biomarker, PK / PD ... 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)
- …of biomarker/PK strategy in collaboration with Translational Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Merck & Co. (Rahway, NJ)
- …transition from early to late-stage governance.-In addition, responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) ... assets Conduct DRC reviews (protocols, strategy, other) Sign off on clinical pharmacology CTD submissions and NDAs Regular updates with key cross-functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to, clinical study reports, investigator brochures, regulatory briefing documents, and clinical and clinical pharmacology sections of INDs, NDAs, BLAs, ... of drug development (eg, nonclinical, pharmacokinetics, biostatistics).ResponsibilitiesWrite critical, complex clinical and clinical pharmacology documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. The Tech Lead must have the ability to develop a strong, positive strategic business… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …not limited to) Clinical Development, Global Medical Affairs, Biostatistics, Clinical Pharmacology , Regulatory, Marketing and Market Access. Work with cross ... functional team to gain an understanding of lifecycle management and plan for strategy and execution. Occasional early/late meetings to communicate real time with other time zones such as Japan. Education/Experience: o Express an interest in Leadership and… more
- Merck & Co. (South San Francisco, CA)
- …in cardiovascular and metabolic diseases to join our Quantitative Biosciences ( Pharmacology ) department. The successful candidate will have direct line management of ... to consider joining our team.Key responsibilities:Develop and support comprehensive pharmacology strategies targeting obesity, immuno-metabolic, and cardiovascular diseases to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Quantitative Pharmacology and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to routinely enable ... PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into programs… more
- Merck & Co. (Rahway, NJ)
- …PK/PD models, population pharmacokinetic models, exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial ... Job DescriptionLocation: WP or RYThe Quantitative Pharmacology and Pharmacometrics (QP2) department drive model-informed drug discovery and development (MIDD) to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... Please note that standard commute is (less than) The Quantitative Pharmacology and Pharmacometrics (QP2) department drives model-informed drug discovery and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with organizational objectives and therapeutic area strategies. Collaborate KOLs and other clinical stakeholders as well as sales and marketing leadership to assess ... bias Staying Current on Current Trends: Stay up to date on the latest clinical research and best practices related to our products and therapeutic areas, providing… more
- Ochsner Health System (Marrero, LA)
- …American Heart Association. Knowledge Skills and Abilities (KSAs) Knowledge of pharmacology , laboratory tests and telemetry. Ability to safely monitor patients ... nurses and technicians. Promotes the adoption of nursing protocols and clinical practice guidelines to support evidence-based practice. Manages conflict on assigned… more
- Bayer (Cambridge, MA)
- **Senior Director Clinical Pharmacology Lead** The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive experience and knowledge of the ... Clinical Pharmacology (CP) field for all phases...Clinical Pharmacology (CP) field for all phases of Oncology drug...approval with a competitive and state-of-the-art product label. The Clinical Pharmacology Lead builds an end-to-end … more
- AbbVie (South San Francisco, CA)
- …Purpose: Conceives, executes and effectively manages and communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve ... study proposals and leads those efforts. Anticipates and critically evaluates Clinical Pharmacology , PK/PD or regulatory advances, strengths, weaknesses,… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Clinical Pharmacology and Pharmacometrics (CP&P) team at BMS is responsible ... development teams and commercial colleagues to provide input on clinical pharmacology profiling, dose optimization, formulation bridging, and combination… more
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