- Lilly (Indianapolis, IN)
- …wage for this position is $118,500 - $173,800 **Position Brand Description:** The Clinical Trial (CT) Manufacturing organization is responsible for the on-time ... delivery of drug product in support of clinical trials (Phase 1 through 4) as well as...technical and operational components of drug product supply. The Associate Director, CT Manufacturing and Operations has accountability for… more
- Lilly (Indianapolis, IN)
- …Lead is to lead the creation and execution of the exploratory and biopharmaceutics clinical development plans at a molecule level, with technical leadership and ... this role is responsible for all aspects of global clinical trial operations within the plan, as...model chosen and motivated by the needs of the clinical development program the Consultant may be… more
- Lilly (Indianapolis, IN)
- …ability to lead development of creative data solutions to address clinical development challenges + Passionate about improving technological solutions using ... onsite/2 days remote **Purpose:** This role is responsible for trial level clinical data strategy including database...apply this knowledge to data solutions + Utilization of clinical /drug development knowledge and an ability to… more
- Lilly (Indianapolis, IN)
- …mentoring role. - The development , conduct and reporting of corporate/global clinical trial (s) in support of registration and commercialization of potential ... steatohepatitis (MASH) trials, to support a future MASH outcome trial . - The CRP will work with a broader...clinical customer community, including thought leaders; - The development and implementation of the business unit and global… more
- Lilly (Indianapolis, IN)
- …at the compound level. The TA Associate Director engages at a trial level with the therapeutic area, clinical design and other appropriate partners ... to make life better for people around the world. **Job Description** The TA Associate Director, Clinical Laboratory Sciences will have early engagement with the… more
- Lilly (Indianapolis, IN)
- …of assets. + Champions the asset strategy and drives translation of the strategy to the Clinical Development Trial Lead staff. Ensures that all clinical ... of submissions, inspections, and publications. The Clinical Development Program Lead reports to the Associate ...considered. + Serves as mentor for clinical development managers, clinical trial project… more
- IQVIA (Avon, IN)
- …training and experience. Req * Knowledge of clinical trials - Knowledge of clinical trial conduct and skill in applying applicable clinical research ... the core project team. * Accountable for the strategic development and execution or delivery of clinical ...GCP and relevant local laws, regulations and guidelines, towards clinical trial conduct. Broad protocol knowledge, therapeutic… more
- Lilly (Indianapolis, IN)
- …in new product development activities over the entire spectrum of drug development and clinical trial phases. Specific activities include developing or ... global Development team, Therapeutic Area Program Phase, Early Phase/ Clinical Pharmacology, and Translational Medicine team(s). The Associate Vice President… more
- Lilly (Indianapolis, IN)
- …internal and industry data standards, and ownership for data standards across the clinical trial data flow. This position collaborates with Data Standards ... be used and followed at each stage of the clinical trial dataflow, including terminology, data verification... development of data standards solutions to address clinical development challenges. + Passionate about improving… more
- Astrix Technology (Indianapolis, IN)
- …space. + Working knowledge of Clinical & Regulatory systems such as Clinical Trial Management System (CTMS), electronic Trial Master Files (eTMF), ... for the sale and growth of Astrix Technology Group's Clinical and Regulatory Consulting services to a portfolio of...of 80 % of their time in new business development . + Demonstrate business development outreach through… more
- Merck (Indianapolis, IN)
- …the role of Associate Director QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects ... Responsibilities:** + Serving as an expert representative for QP2-IO on Oncology clinical development teams. + Framing critical questions for optimizing… more
- Merck (Indianapolis, IN)
- …(popPK), PK/PD models, exposure response (ER) models, model-based meta analysis (MBMA), clinical trial simulations (CTS) and disease progression modeling into ... development programs, and author or co-author strategic documents. ** Associate Directors are expected to have or be developing...seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions… more
- Lilly (Indianapolis, IN)
- …+ Experience with study development process and ERB submission requirements + Clinical trial experience in a capacity such as Data Associate , ... for the final delivery of data collection instruments (English/Translations) used in clinical trials. The C/T associate director also provides guidance on… more
- Lilly (Indianapolis, IN)
- …edit, review, coordinate, and complete the regulatory documents supporting clinical development /product registration. + Build scientific-based rationale that ... cardiovascular, immunology or endocrine expertise). + Experience writing regulatory, clinical trial documents and/or publications + Demonstrated ability… more
- Lilly (Indianapolis, IN)
- …Medical Device Reporting (MDR) and other regulatory reporting requirements. + Support Clinical Trial complaint management by establishing processes for each ... unique trial , ensuring investigations are completed and approved, performing investigations...global documents or systems change and in support of development projects and project launches. Perform gap assessments on… more
- Lilly (Indianapolis, IN)
- …in defined functional business areas, for example, medical writing, regulatory affairs, or clinical trial management. + Knowledge of quality systems + Ability to ... purpose of the Associate /Senior Associate /Principal Associate - MQO is to support the development... Associate - MQO is to support the development and implementation of the strategy for quality systems… more
- Lilly (Indianapolis, IN)
- …deliver required materials (such as API, drug product formulations, registration stability lots, clinical trial materials, etc) as needed to support a particular ... Brand Description:** This role is responsible for managing the development and implementation of an integrated technical plan for...sub-teams of moderate to high complexity and scope through development and execution of project plans that lead to… more
- Lilly (Indianapolis, IN)
- …use for internal and external manufacturing, as well as occasional FTZ support for clinical trial development . + **FTZ Structure Establishment:** Lead the ... establishment of new FTZ structures and zones at five new manufacturing sites. + **Stakeholder Collaboration:** Partner with external consultants and internal collaborators, including Manufacturing Strategy, Supply Chain, Finance, Procurement, Tax, and Legal,… more
- Merck (Indianapolis, IN)
- …GSC, US Regional Director of Medical Affairs (RDMA) (where applicable), US Global Clinical Trial Organization, Global Medical and Scientific Affairs (GMSA) TA ... in our Company's Research Laboratories, US Medical Affairs (our Research & Development Division, USMA). The role drives scientific excellence and optimizes field… more
- Lilly (Indianapolis, IN)
- …achieve safety, quality, service and financial performance at a manufacturing site or clinical trial organization + Serving as the link between Lilly Affiliates ... someone else's life. **Responsibilities** As a Supply Chain SCALE (Supply Chain Associate Learning Experience) Associate , you will experience an exciting career… more