- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- AbbVie (Florham Park, NJ)
- …Events (AE's) and Serious Adverse Events (SAE's) if assigned to AbbVie conduct on clinical studies . + Leads the development and execution of advisory boards, ... them to completion, resulting in high quality publications. + Lead functional and cross functional teams responsible for discrete...the design of protocols. + Ability to run a clinical study independently with little supervision. +… more
- Hackensack Meridian Health (Hackensack, NJ)
- …Transformation Facilitator (PCPF) will report to the Patient Centered Transformation Practice Lead who reports to the Manager of Outcomes. The PF will support ... self-management social awareness relationship management. + Assist practices in redesigning clinical documentation and or workflow to support desired changes. +… 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
- Bristol Myers Squibb (Summit, NJ)
- …New Brunswick, New Jersey or Summit, New Jersey Our Chemical Process Development group is a team of organic chemists, analytical chemists, and chemical engineers ... focus on developing safe, economical, sustainable, and robust processes to support clinical trials and the launch of new medicines across various drug modalities… more
- AbbVie (Florham Park, NJ)
- …Safety Statistical Analysis Plans (ISS SAPs). + Ensure consistency across documents (eg, PSSAP, study SAPs, ISS SAP). + Lead the development of safety data ... Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description Purpose: The Safety Statistics Group (SSG) at AbbVie is an important strategic part of Data and… more
- AbbVie (Florham Park, NJ)
- …/ Advisory Board & EE Engagement Plan generation in line with TA plan. Lead Conference planning and execution. + Generates clinical and scientific data per ... and provider interactions (HCP's, Patients and Payers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational… more
- Bristol Myers Squibb (Summit, NJ)
- …of robust small molecule drug product formulations. + Develops oral formulations for clinical studies and commercialization. + Leads drug product formulation and ... senior principal scientist to join the Oral Product Development group within the Drug Product Development function. The drug.../ or serve as a matrix team leader to lead formulation development as well as providing necessary guidance… more