- Pfizer (Pearl River, NY)
- …the way in healthcare and make a lasting impact on society. **What You Will Achieve** As a Clinical Study Group Lead , you will be an operational and ... 5 submission subteams and endgame inspection readiness. In the Clinical Study Group Lead... studies + Accountable to deliver excellence in clinical study team leadership for a portfolio… more
- Pfizer (New York, NY)
- …for patients. **What You Will Achieve** You will ensure that the clinical studies conducted in the Pfizer Biopharma Group are within time, budget and scope. ... You will help us plan and direct the clinical studies . You will create the timelines...level status reporting per organizational norms and expectations. + Lead the study team and associated deliverables… 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
- 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
- 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
- Pfizer (New York, NY)
- …Intake processes to optimize efficiency and compliance with regulatory requirements. + Lead and manageaudits within the Study Organization (SO), including ... (R&D) engine providing analytics & intelligence to customers and stakeholders across clinical and regulatory functions within PRD & POD. The Site Intelligence,… more
- Sanofi Group (Morristown, NJ)
- …key external stakeholders. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Knowledge of ... clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio...and ESC applications + Liaise with the investigators of study applications. + Present studies to the… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Director of the Medical Science Early-Stage, the Director, MSES will lead clinical and scientific aspects of Early Development studies from Phase 0 through ... for successful execution, analysis, interpretation of results of early-stage clinical studies . + Leads or participates in...+ Prepares and/or directs the preparation and review of study protocols, clinical study reports… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …the preparation/review of related key documents (ie protocols, Investigator's Brochures, clinical study reports, summaries for regulatory submissions). The ... the Clinical Development plan + Works with Clinical Supplies Group to ensure clinical...and direction to the review and finalization of Protocols, Clinical Study Reports and other relevant … more
- Sanofi Group (Morristown, NJ)
- …relevant statistical matters: + Provide high quality input into the design of the clinical study (including protocol development), the setup and conduct of the ... development. As Associate Statistical Project Leader, you will lead several oncology early phase projects or late phase...into interpretation and discussion of results sections for the clinical study report (CSR) and/or publications to… more
- Bristol Myers Squibb (Summit, NJ)
- …and registrational strategy + **Accountable for the** Clinical Pharmacology Plan + ** Lead ** design of clinical pharmacology studies and manages data ... clinical study design...cross-functional drug development teams, and regulatory submissions; serves as Clinical Pharmacology subject matter expert + ** Lead … more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Advisory meetings, development of target indications, clinical development plans, study designs and program feasibility. + Lead program specific team ... clinical medicine and drug development processes. He/she will be the clinical lead for large global, multidisciplinary teams, mentoring and motivating… more
- Sanofi Group (Morristown, NJ)
- …and Finances to facilitate financial exercises throughout the year, for both tactics and Clinical Studies + Study Prioritization process: + CSS SRC approval ... individual will work closely with his/her respective Medical Program Lead (MPL) and TA Global Medical Team (GMT), both...study data milestones and budget specific to all studies defined in the approved iEGP + Compliance reporting… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …such as team capability development. **EXAMPLE RESPONSIBILITIES:** + Acts as biostatistics lead on clinical studies or other non-molecule projects. ... providing statistical consultation on clinical development plans, clinical trial design and clinical study... endpoints and authors statistical analysis plans. Typically assigned clinical studies or other projects of increasing… more
- Sanofi Group (Morristown, NJ)
- …a cross-functional team. + Ability to understand and effectively communicate vaccine clinical studies , both interventional and observational + Ability to analyze ... of company-sponsored clinical trials (ie, Ph 4 post-marketing and observational studies ) for new products that may join franchise portfolio in accordance with… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Specialist to manage sample data processes and biobanking operations for Oncology clinical studies and research initiatives. Responsible for leading clinical ... we believe there is a lot of opportunity to lead in this growing group . This role...ROLE LOOKS LIKE: + Responsible for the interpretation of clinical /non- clinical study protocols and associated… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- … clinical and health economic literature, including disease state information, clinical trial design and results, and Pharmacoeconomics studies , in order ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, supply chain,and business development… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …Operations to ensure e-CTD compliance. + As required, serves as a global regulatory lead on a specific or assigned clinical program. **Qualifications** + Minimum ... (edaravone) oral suspension in 2022. The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.… more
- AbbVie (Florham Park, NJ)
- …Statistical Programming and other stakeholders to evaluate existing databases, both clinical studies and real-world databases, conduct feasibility assessment to ... + Provide expertise to design, analysis and reporting of clinical trials or other scientific research studies ....pre-planned safety analyses and ad hoc requests. + (SSG) Collaborate/ lead within the Safety Statistics Group to… more
- Sanofi Group (Morristown, NJ)
- …scientific leadership for responsible projects. Accountable for statistical aspects of clinical development plans, studies and submissions activities (when ... As a Statistical Project Leader in Biostatistics, you will Lead one or more indications/projects in an Oncology Development at Sanofi, under minimum supervision of… more