- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … programs. The Associate Director role will be responsible for all aspects of clinical trial management and oversight of trial teams. Relationships This ... Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We...Director of Clinical Operations Collaborate with the Clinical Trial Leads and study teams with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...as programs or franchises.When sitting on a study team, lead the study team to develop a cross-functional, integrated… more
- Genmab (Plainsboro, NJ)
- …Manager you will play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In ... cold chain management.Proven experience working with CMOs for clinical trial supplies, including vendor management.Ability to lead cross-functional projects… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We...product Support all areas related to patient safety in clinical trials Act as member of the trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here,...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …(phase I trials) o Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), ... with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the… more
- Merck & Co. (Rahway, NJ)
- …of clinical pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational ... Late-Stage Clinical Development.- The AVP provides strategic oversight for the early clinical space, determining and implementing the initial clinical … more
- Aequor (South San Francisco, CA)
- …: 1 year The Position: The mission of the Data Intelligence team in the Early Clinical Development (ECD) department is to optimize the support of clinical ... applying statistical methods (hypothesis testing, regression analysis, data modeling) to analyze clinical trial data Proficient in data visualization tools (eg,… more
- Genmab (Plainsboro, NJ)
- …program strategy for assigned trials/compounds and participate in the development of the clinical development plan (CDP). Lead creation and review of clinical ... supporting registration, market access, and commercialization of the compound(s). Oversee early -stage programs and develop clinical programs including component… more
- Genmab (Plainsboro, NJ)
- …/ EU /Japan regional healthcare systems, payer preferences, and market dynamics to lead the market access and pricing launch strategies.This position is hybrid based ... the value of assigned asset(s),Provide strategic market access input to inform global clinical development program of assigned asset(s) and ensure it is optimized to… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …degree and minimum of 12 years relevant pharmaceutical industry experience, 8 years within Clinical Trial Management. Experience with early phase clinical ... for delivery of one or more complex programs in Clinical Trial Management (CTM). This individual is...Responsible for development and implementation of operational strategy, driving early study planning budget and timelines from Clinical… more
- J&J Family of Companies (Raritan, NJ)
- …monitoring and close-out. Partner with the Clinical Trial Assistant (CTA), Trial Manager (TM), Site Strategy Lead (SSL) and Trial Delivery Leader ... & Johnson Innovative Medicine R&D is recruiting for a Lead Site Manager - Early Development. This...trial monitoring experience is required. + Experience monitoring early development and clinical pharmacology studies (Phase… more
- Schrodinger (NY)
- … programs as a member of the cross-functional asset development teams and leader of clinical study teams. The Early Clinical Development (ECD) team supports ... clinical quality, and medical writing. The Director of Early Clinical Research will have experience in... Clinical Research will have experience in oncology clinical drug development, clinical trial … more
- Novo Nordisk (Lexington, MA)
- …part in the unique opportunity to bring highly innovative pharmaceutical products through early clinical development. The candidate is a team player, detail ... diverse functional teams to plan, design, execute, and analyze early clinical trials, especially first-in-human (FIH) trials.... Clinical Development unit as the US/international clinical lead for several internal GNAT development… more
- Bristol Myers Squibb (Summit, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. + Successfully leads, plans, and executes ... support clinical development planning in collaboration with Early Clinical Development p hysician (s) ....protocol requirements and educate team members. + Plan and lead the implementation of clinical study startup/conduct/close-out… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Provides medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... Development Expertise Strategy:** + In collaboration with the Global Clinical Lead (GCL), if applicable, leads the...achieve the Target Product Profile (TPP) + Development of clinical sections of trial -level regulatory documents (eg,… more
- Dana-Farber Cancer Institute (Boston, MA)
- …in training new staff. + Liaison with community partners in setting up clinical trial and recruitment processes. + Leading recruitment and consenting efforts ... cancer detection and treatment, we've created a robust, integrated clinical /research program -- Centers for Early Detection...(CRC II) will be an integral part of the clinical research program and lead recruitment as… more
- System One (Tarrytown, NY)
- …company. Must have a MS or PhD in Statistics/Biostatistics with 2+ years early phase clinical trial experience. The Biostatistician implements and ... Job title: Biostatistician - Early Clinical Development Location: Fully Remote...clinical studies under the supervision of Therapeutic Area lead biostatistician or project lead statistician. In… more
- Stanford Health Care (Palo Alto, CA)
- …Research Nurse Professional -serves to educate patients and families on the clinical trial treatments, required testing, and protocol specific visits and ... trial specific requirements in alignment with all clinical trial and operational requirements. **Locations** Stanford...vendors as noted below. + Internal Contacts: Disease program lead physician, NP, PA, Clinical Pharmacist, shared… more
