- ThermoFisher Scientific (Boston, MA)
- …maintenance, close out, and database lock, depending on the client's needs. Client-dedicated Clinical Trial Associate (FSP CTAs) work directly with clients ... clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy… more
- Orchard Therapeutics (Boston, MA)
- …Specialty Pharmaceutical Company. Reporting to the Director of Clinical Operations, the Clinical Trial Associate (CTA) will be responsible for providing ... Location: Boston Reporting to: Senior Director, Clinical Operations Job Summary Orchard Therapeutics is a...project administrative and tracking support to the Clinical Study Managers for their assigned clinical … more
- US Tech Solutions (Cambridge, MA)
- …on TMFs to ensure completeness and readiness for audit/inspection + Contributes to clinical trial excellence initiatives **Main responsibilities and tasks** + Be ... responsible for **setting-up, monitoring verifying and archiving** the ** clinical Trial Master File (TMF)** + In charge of the Client **electronic TMF (and/or… more
- Takeda Pharmaceuticals (Boston, MA)
- …serve the Clinical Sub-Team (CST)/Study Execution Team (SET) for end-to-end clinical trial delivery compliance and an aligned approach to inspection ... and empower you to shine? Join us as an Associate Director, GCP Excellence in Clinical Trials...Champion change and provide direct operational excellence strategies for clinical trial delivery projects and initiatives. **_A_**… more
- Takeda Pharmaceuticals (Boston, MA)
- …quality are considered. + Enable a compliant quality system in safety and clinical trial delivery systems via CPMQ continual improvements projects. Actively ... of my knowledge. **Job Description** **About the role:** The Associate Director, Clinical and Safety Quality Compliance...represent in continual improvement projects, related to safety and clinical trial delivery in partnership with GDO,… more
- Takeda Pharmaceuticals (Lexington, MA)
- … Science Lead and TA Medical Teams. + Drive and deliver all aspects of clinical trial execution from study concept to final reporting **Research and Strategic ... application is true to the best of my knowledge. **Job Description** ** Associate Director, Clinical Research, Value & Evidence Generation, US Medical**… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …that will inspire you and empower you to shine? Join us as an Associate Medical Director, Clinical Science in our Gastrointestinal & Inflammation Therapeutic ... a vital contributor to our inspiring, bold mission **POSITION OBJECTIVES:** The Associate Medical Director leads and drives strategy for the overall global … more
- Takeda Pharmaceuticals (Boston, MA)
- …Breach review board meetings. + Lead complex quality investigations impacting the clinical trial delivery systems. + Provide Quality Leadership for Serious ... true to the best of my knowledge. **Job Description** **About the role:** Associate Director, Clinical Program Quality Investigations is responsible for ensuring… more
- Takeda Pharmaceuticals (Boston, MA)
- …study team members. + Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to effectively conduct accurate ... and empower you to shine? Join us as the Associate Director, Site Start Up and Maintenance based remotely...pharmaceutical industry or related field required. + Expertise in clinical trial regulations and ethics committee submissions.… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Director/Director). + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are necessary and ... products for the maintenance of everyday health We are seeking a Director, Global Clinical Development (GCD) who will be responsible for the design and oversight of … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- … Director/Director). + An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and ... **Job Description** Otsuka is seeking a Director, Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research… more
- Merck (Cambridge, MA)
- …+ Develop model-based strategies (translational PK/PD strategies, mechanistic model, POPPK/PD, clinical trial simulations, etc) for quantitative analyses, within ... / Rahway, NJ is seeking a curious and collaborative Associate Director to support our rapidly expanding cardiometabolic and...drug development including, but not limited to dose selection, clinical trial design, and go/no-go decisions. +… more
- Merck (Boston, MA)
- …translational PK/PD approaches, population pharmacokinetic models, exposure-response models, clinical trial simulation, disease progression models, quantitative ... and biologics in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications… more
- Bristol Myers Squibb (Cambridge, MA)
- …the next wave of breakthrough therapies to reach patients faster through innovative clinical trial designs. **Responsibilities** + Lead a team of PhD level ... in neuroscience drug development and cutting-edge approaches for molecular/imaging/digital biomarkers and clinical trial design + Proficiency using R and 1+… more
- Takeda Pharmaceuticals (Boston, MA)
- …to cross-functional business partners about the need for additional data generation - clinical trial , real world evidence (RWE) such as registries and databases ... strategies for Health Technology Appraisal (HTA; including the EU Joint Clinical Assessment [JCA]) and payer assessments to optimize rapid, broad patient… more
- Merck (Boston, MA)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta-analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas....seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of those cancer patients and their families undergoing therapy in a clinical research trial . Strong interpersonal, organizational and communication skills are ... with the physician, is responsible for the implementation and evaluation of clinical research in their specific program/area. The CRN has expert knowledge of… more
- Takeda Pharmaceuticals (Boston, MA)
- …communications skills. + Specialized statistical expertise in multiple therapeutic areas or clinical trial development phases. + Strong inter-personal skills. + ... order to bring life-changing therapies to patients worldwide. Join us as a Associate Director, Statistics in our Data and Quantitative Sciences (DQS) team. This team… more
- Bristol Myers Squibb (Cambridge, MA)
- …synopses and protocols. Contribute in cross-functional rapid response teams to respond to Clinical Trial Application (CTA) queries on new protocols and protocol ... coordination with clinical plans and marketing objectives. + Experience with clinical trial assays (CTA) in drug clinical trials in communicating between… more
- Rhythm Pharmaceuticals (Boston, MA)
- …PBRERs, Posters and Manuscripts) + Provide hands-on support for the global clinical trial transparency requirements from study registrations to results postings ... barriers, together. Opportunity Overview Rhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently develop as… more