- Merck & Co. (Rahway, NJ)
- …offers an opportunity for the Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to ... PK/PD models, population pharmacokinetic models, exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial… 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)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... areas centered around rare diseases and immune disorders. Summary The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- Bristol Myers Squibb (Summit, NJ)
- …to Phase 2/3 clinical study design and registrational strategy + **Accountable for the** Clinical Pharmacology Plan + ** Lead ** design of clinical ... teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert + ** Lead and...related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience with… more
- Merck (Rahway, NJ)
- …registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to ... **Job Description** **Position Description:** ** Director , Quantitative Pharmacology and Pharmacometrics Immunology (R5)** The Quantitative Pharmacology and… more
- Merck (Rahway, NJ)
- …registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to ... **Job Description** The Quantitative Pharmacology and Pharmacometrics (QP2) Department of our Company's...Company's Research Laboratories is seeking a curious and collaborative Director to support our rapidly expanding ophthalmology pipeline. This… more
- System One (Basking Ridge, NJ)
- …Pay Max: $100- $120 (dependent on experience) Fully remote Description: The Director , Clinical Safety, will be a product safety lead or part of a product ... Director Clinical Safety 12 month contract...member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology ,… more
- AbbVie (Jersey City, NJ)
- …2+ years of internal medicine residency with patient management experience required; PhD or Clinical Pharmacology fellowship is preferred in addition to MD / DO, ... guide dose selection and regimen, inclusion/exclusion criteria and safety monitoring for first for clinical trials as well as PMOS. PST lead will be interpreting… more
- Daiichi Sankyo Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology , Clinical Safety and Pharmacovigilance, ... areas centered around rare diseases and immune disorders. **Summary** The Tech Lead manages enterprise level technical projects to ensure homogeneity within IT and… more
- AbbVie (New York, NY)
- …leads those efforts. Anticipates and critically evaluates Statistical, PK/PD, Clinical Pharmacology , or regulatory advances, strengths, weaknesses, opportunities ... for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management. Responsibilities: + Executes… more
- Merck (Rahway, NJ)
- …impact and lead a talented group of pharmacometricians. This Senior Director is expected to be an experienced pharmacometrician with a strong, understanding of ... PK/PD models, population pharmacokinetic models, exposure-response models, quantitative system pharmacology (QSP) and disease progression models, clinical trial… more
- J&J Family of Companies (Raritan, NJ)
- …specialization preferred + Demonstrated knowledge of principles of drug development, pharmacology , clinical trial methodology and design, medical monitoring of ... Johnson & Johnson, is recruiting for a Director , Medical Safety Officer, Oncology (Solid Tumor) to...of assigned Johnson & Johnson products and will strategically lead cross-functional matrix teams responsible for product safety and… more
- AbbVie (Jersey City, NJ)
- …and "How" to mitigate it + Understanding and application of the pharmacology , chemistry and non- clinical toxicology to effectively conduct safety surveillance ... (and could support one large product as the PST Lead ) and ensuring safety of late stage and post...stage) + Understand MOA in close collaboration with preclinical, clinical pharmacy, clinical development, and discovery +… more
- Eurofins (North Brunswick Township, NJ)
- …market leaders in certain testing and laboratory services for genomics, discovery pharmacology , forensics, CDMO, advanced material sciences and in the support of ... clinical studies. In over just 30 years, Eurofins has...In the absence of a Laboratory Manager, the Site Director will assume those duties as well. Is a… more
- AbbVie (Branchburg, NJ)
- …products and during due diligence activities. Responsibilities: *Understand and apply pharmacology , chemistry and non- clinical toxicology to effectively conduct ... supporting Product Safety Leads (PSTs) to translate nonclinical and early clinical safety findings, facilitate benefit-risk decision making and risk mitigation for… more
- Merck (Rahway, NJ)
- …development strategy for novel therapy programs from Preclinical Candidate approval through Clinical Pharmacology testing (Phase 1), and clinical ... investment in clinical development programs. + Development and execution of clinical pharmacology strategies to support later stages of development from… more
- Pfizer (New York, NY)
- …safety for clinical evaluations and safety decisions * Accountable with clinical pharmacology for defining and identifying optimal dose and schedule ... Lead works across the organization and on the cross-functional Global Development Team to lead , develop and execute the clinical development plan of a drug or… more
