- Gilead Sciences, Inc. (Parsippany, NJ)
- …Join Gilead and help create possible, together. **Job Description** Job Description ** Associate Director , Clinical Pharmacology - Oncology** **_*This is ... and study sites to implement and monitor clinical pharmacology studies . Addresses clinical ...regulations, ICH guidelines, and GCP governing the conduct of clinical studies . Has significant knowledge of pharmaceutical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position works with the Director , Clinical Study Startup to establish the strategy driving ... where appropriate and escalate any complex problems to the Director , Clinical Study Startup. This... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and oversees… more
- Bristol Myers Squibb (Summit, NJ)
- …and at governance meetings based on proficiency + **Provide input** to Phase 2/3 clinical study design and registrational strategy + **Accountable for the** ... Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis,...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …key metrics and Key Performance Indicators (KPIs) across studies and within clinical program(s) to track study progress. + Manages all aspects of Quality ... quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable...with senior level management, external vendors, collaboration partners and clinical study personnel for clinical … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Bayer (Whippany, NJ)
- …biopharmaceutical industry, clinical and/or academic work experience; + Understanding of clinical study design, analysis and interpretation as well as the ... to make a real difference, there's only one choice.** ** Associate Medical Director , US Medical Affairs Oncology,...principles of observational studies and health economics/ outcomes research; + Proven record… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... studies including study design, protocol development, CRF review, SAP development, analysis...review. Acts as main statistical contact for the assigned studies and projects. Provides guidance to study … more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The HEOR Associate Director - BU based is accountable for ensuring execution of HEOR projects for priority pipeline programs, ... us. Job Description: Specimen Management Business Unit-JG5 **Position Summary** The HEOR Associate Director for the Specimen Management business is accountable… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... trial design, analysis planning, study results presentation and interpretation, clinical study report authoring, regulatory submissions and publications. +… more
- AbbVie (Florham Park, NJ)
- …on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Associate Director in CMC Statistics is responsible for providing statistical ... strategy meetings. Contribute to strategic planning to ensure statistically optimized non- clinical development plans and assist in the creation of strategic… more
- Bristol Myers Squibb (Madison, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Associate Director , US Medical, Multiple Myeloma will report to the ... asset strategy supporting the MM asset lead and the MM Medical Lead. The Associate Director will provide key contributions for the asset medical strategy in… more
- AbbVie (Florham Park, NJ)
- …level will be determined by the qualifications listed below. Purpose The Associate Scientific Director provides medical and scientific strategic and operational ... practice standards, including regulatory guidelines to meet customer needs. Qualifications Associate Scientific Director Qualifications + Bachelor's Degree in… more
- Bristol Myers Squibb (Madison, NJ)
- …by leveraging internal and external best practices and exploring technologies. The Associate Director (AD), Informed Consent Management role reports to the ... for managing the end-to-end process for IC for BMS-sponsored clinical trials. This includes a centralized triage function for... Director of Informed Consent Management. The AD will be… more
- Pfizer (Pearl River, NY)
- …expected to develop effective collaborations with relevant stakeholders including Study Statisticians, Clinical , Development Operations, PharmSci, Regulatory and ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and unique opportunity for a medical writer to join our dynamic team at the Associate Director level. You will author a wide range of regulatory documents ... a wide variety of documents of all types and complexities, such as clinical study reports (CSRs) (all phases), investigator's brochures, CTD summaries/overviews,… more
- Bristol Myers Squibb (Summit, NJ)
- …no better place than here at BMS with our Cell Therapy team. The Associate Director , Drug Product External Manufacturing QA provides Quality oversight to ... Deviations, CAPAs, Change Controls, Batch Record Review, Lot disposition to support the clinical and commercial release of Drug Product. This role will also develop… more
- AbbVie (Florham Park, NJ)
- …documents. + Present at various departmental and cross functional teams such as study teams, Clinical Pharmacology leadership team, Journal club. + Drives small ... leads those efforts. Anticipates and critically evaluates Statistical, PK/PD, Clinical Pharmacology, or regulatory advances, strengths, weaknesses, opportunities and… more
- Lilly (Morristown, NJ)
- …partners as appropriate and facilitate collaborative research opportunities. MSLs partner with clinical development in support of studies and investigators to ... The anticipated wage for this position is $145,500 - $213,400 Scientific and Clinical Experts (SEs/CEs) are individuals who are noted for their expertise in a… more
- Sanofi Group (Bridgewater, NJ)
- …phase 3b and phase IV clinical studies , including informing clinical development plans and study designs to ensure differentiating and relevant outcomes ... excellence in medical launch readiness. The role will bring in-depth knowledge of clinical studies , ensuring that medical plans and strategies are underpinned by… more