- Merck & Co. (North Wales, PA)
- …statistical programming activities for multiple and/or large/complex late stage drug/vaccine clinical development projects.- Accountability predominantly includes ... the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical trials to world-wide regulatory application submissions and… more
- Merck & Co. (North Wales, PA)
- …human health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one ... or more projects.-- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis datasets, tables, listings, figures), the span of which range from individual clinical… more
- Merck & Co. (Boston, MA)
- …Immunology strategy, bridging the continuum from Discovery Research through Late- Stage Clinical Development.-The AVP provides strategic oversight for the early ... proof-of-concept/ pharmacology/ principle and the transition from early to late- stage governance.-In addition, the AVP's responsibility will include the clinical… more
- Merck & Co. (Rahway, NJ)
- …Area and strategy, bridging the continuum from Discovery Research through Late- Stage Clinical Development.- The AVP provides strategic oversight for the early ... strategy through proof-of-concept/pharmacology/principle and the transition from early to late- stage governance.-In addition, responsibility will include the clinical pharmacology… more
- Catalent (CA)
- …Pharma Solutions is recruiting for an Account Director, Pharmaceutical Softgel and Late- Stage Oral Solids. This position will be field-based and will be responsible ... and commercial supply business for Rx softgel and late stage oral solid products with new customers, and for...United States.Identify, qualify, and pursue Rx softgel and late stage oral solids business opportunities within the assigned portfolio… more
- Merck & Co. (Rahway, NJ)
- …laboratory capabilities in support of drug substance manufacturing processes for late- stage pipeline and commercial products for biologics (therapeutic proteins) and ... internal and external program partners, this individual will support late stage and commercial program activities within BDSC.Scope includes:Participates in and/or… more
- Merck & Co. (North Wales, PA)
- …the globe. Working with the Asset Development Team (ADT's), early- & late- stage clinical development teams, the Biomarker (BMx) leads will develop asset-specific ... development for our Company's Oncology programs. Working with early- and/or late- stage clinical development teams, he/she will have the opportunity to drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …project teams will be defined based on the project needs and the respective development stage of the project. The CMC Lead will support the Sr. CMC Lead on complex ... and/or late- stage project or act as main CMC Lead of an early- stage project. He/she has responsibility for the overall strategy and status of the project with… more
- Merck & Co. (Rahway, NJ)
- …of advanced formulation and process development tools, and biopharmaceutics principles that satisfies stage 1 and stage 2 validation criteria and follows QbD ... principlesOversee formulation and process scale up from first in human through line of sight to commercial productionOversee and review CMC authoring activities for DP manufacturingEnsure successful and effective technology and knowledge transfer from research… more
- Eisai, Inc (Exton, PA)
- …a scientific and technical resource to support several early to late stage manufacturing programs.This position will be responsible for the review and interpretation ... from pre-IND through phase 3, knowledge of the regulatory requirements at each stage of clinical development is essential.This position will have a direct impact on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …position may be assigned to any therapeutic area and work on projects at any stage of development.As a member of the GMP&L function this position is also accountable ... management in a timely manner. Prepares scope change proposals and drafts stage gate proposals for formal presentation to senior management.Generates and maintains… more
- Merck & Co. (Rahway, NJ)
- …activities involving investigational compounds in Immunology. With a focus on late- stage development, the Senior Clinical Director will manage the entire cycle ... phase 2 or 3 clinical trials in immunology therapeutic areas. Experience in late stage IBD trials and regulatory filing is preferred.Minimum of 3 years of clinical… more
- Merck & Co. (North Wales, PA)
- …partner leaders at all levels to maximally leverage assigned Research & Development stage alliances for both our company and its Research & Development partners.This ... Francisco CA.Primary Responsibilities:Participate in potential partner due diligence and/or late- stage negotiations to assess cultural fit, ensure understanding of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Global Clinical Science Strategy and delivery of clinical studies in late stage developmentLead and manage the multiple late development and/or transitioned asset ... of needs including training, data review tools, etc.Standing PRG reviewer for mid-to-late- stage asset protocolsCore or extended member on Disease Area Strategy Teams… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …portfolio of marketed medicines and novel product candidates, from early- to late- stage development, in neuroscience and oncology. We actively explore new options ... have proven experience leading a program or function in late- stage drug development, preferably a highly complex and/or high...optimize the value of the product, and prepare for stage gate presentations to the Early Development Project Review… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …portfolio of marketed medicines and novel product candidates, from early- to late- stage development, in neuroscience and oncology. We actively explore new options ... BTC (Biliary Tract Cancer) and GEA (Gastroesophageal Adenocarcinoma) will lead the late- stage development and life-cycle management of a key Oncology asset for BTC… more
- Bakerly Ranch LLC (San Antonio, TX)
- …size, shape, color, and quality meets criteria for packaging (this is the third stage of the multi- stage , bread-making process, that depends on the accuracy of ... the operator). The operator will participate in R&D trialing and training to develop and enhance product quality, will be responsible for maintaining a clean work environment that includes but is NOT limited to maintaining proper sanitation practices, daily… more
- Bakerly Ranch LLC (San Antonio, TX)
- …and quality meets criteria for proofing, baking, and packaging (this is the second stage of the multi- stage , bread-making process, that depends on the accuracy ... of the operator). The operator will participate in R&D trialing and training to develop and enhance product quality, will be responsible for maintaining a clean work environment that includes but is NOT limited to maintaining proper sanitation practices, daily… more
- Bakerly Ranch LLC (San Antonio, TX)
- …meets criteria for portioning, proofing, baking, and packaging (this is the first stage of the multi- stage , bread-making process, that depends on the accuracy ... of the Baker). The Baker will participate in R&D trialing and Baker training to develop and enhance product quality, will be responsible for maintaining a clean work environment that includes but is NOT limited to maintaining proper sanitation practices, daily… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …portfolio of marketed medicines and novel product candidates, from early- to late- stage development, in neuroscience and oncology. We actively explore new options ... portfolio of marketed medicines and novel product candidates, from early- to late- stage development, in neuroscience and oncology. We actively explore new options… more
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