- Merck & Co. (Rahway, NJ)
- …Director, PDT lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publications.Participation in internal...entire Clinical Teams in the execution of clinical studies .--Will report and work collaboratively with… more
- Merck & Co. (Rahway, NJ)
- …of Clinical Scientists in the execution of clinical studies .Work closely with a cross-functional group of experts in commercialization, regulatory ... support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication; andParticipation in internal and joint… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution ... with Clinical Scientists (CS)Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … group regarding new indications for Life Cycle Management.Additional non- study related activities: Clinical Development involvement in due diligence ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of... studies including study design, protocol development, CRF review, SAP development, analysis… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and control of Clinical Project Budget in support of Phase I-III clinical studies .Partner with Project Management, Clinical Operations and other ... Legacy of Innovation 110 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...are always maintained and accurate.Accountable to the Global Team Lead (GTL) and GPT (Global Project Team) for the… more
- Merck & Co. (Rahway, NJ)
- …interfacing with scientists who are manufacturing drug substance to support early clinical studies , scaling up new chemistries, and exploring new technologies. ... Specialist - Prep Lab Engineer Job Description: The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Join a Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve ... to a strong portfolio of medicines for cardiovascular diseases, under the Group 's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage… more
- 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 ... enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... Legacy of Innovation 125 Years and Counting! Daiichi Sankyo Group is dedicated to the creation and supply of...drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs… more
- Sanofi Group (Morristown, NJ)
- …results + Comply with company standards & local regulations Design and Oversee Clinical Studies + Be the strategic lead in the development of clinical ... oversight and approval of the protocol, Key Results Memo, Clinical Study Report and for other ...medical input & support for all activities related to clinical studies such as medical training, feasibility,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …** Clinical Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... Clinical Scientists (CS) + Interpretation and presentation of clinical study (ies) data to internal and external...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …as delegate of Therapeutic area (TA) Lead Clinical Scientist; Member of the Clinical Study Team and Global Clinical SubTeam + Line Manager for CS ... studies and ensures scientific integrity and interpretation of study data of a clinical development program....day may include the following:** + May function as lead Clinical Scientist (CS) for program, and/or… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …(ICH) guidelines and Good Clinical Practice (GCP) governing the conduct of clinical studies . + Proven ability and experience to effectively execute ... Operations leader for a Director position within our Oncology Group . Clinical Operations is responsible for the...to support a fluid 'One Ops' workforce. You will lead and/or effectively engage in Clinical Operations,… more
- Merck (Rahway, NJ)
- …Director, PDT Lead will manage the entire cycle of clinical development, including development strategy, study design, initiation, execution, monitoring, ... safety and efficacy as well as new drug applications, clinical study reports, or publications + Participation...entire Clinical Teams in the execution of clinical studies . + Will report to and… more
- Sanofi Group (Morristown, NJ)
- …datasets, medical imaging data, continuous data from wearable devices) collected from clinical studies for both formal reporting and exploratory analyses ... progress. The Statistical Biomarker Leader is involved in the clinical development process from early on to lead...concepts and techniques in various biomarker data collected in clinical studies + General knowledge of pharmaceutical… more
- Sanofi Group (Morristown, NJ)
- … Programs** - Serve as the medical lead for switch programs and clinical studies (eg, Actual Use Trials), ensuring compliance with clinical , regulatory, ... **Global Switch Medical Strategy Lead ** + _Location: Morristown, NJ /Hybrid_ **_About the...understanding of technical requirements for switch. Proven experience in clinical and consumer behavior studies for switches… more
- Bristol Myers Squibb (Madison, NJ)
- …training Clinical Development Expertise & Strategy + In collaboration with the Clinical Development Lead , designs and develops clinical plans and ... targets + Provides oversight and medical accountability for a group of studies + Leads the analysis...reports, briefing books and submission documents to support closure, clinical narratives, reporting and filling of the study… more
