- 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
- Merck & Co. (Rahway, NJ)
- …planning and execution of strategies for Digital/Technology enablement of late- stage drug substance and product (LM/SM/Vaccine), process development, product ... planning and execution of strategies for Digital/Technology enablement of late- stage drug substance and product (LM/SM/Vaccine), process development, product… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision ... Medicine a reality for patients who are likely to benefit from our therapeutics.Responsibilities- Leads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development… more
- Aequor (Thousand Oaks, CA)
- …aSEC, aCEX, aHIC, calorimetry, and light scattering to support the diverse early- stage pipeline. Previous experience with MS and MS/MS based PTM characterization ... desirable. Previous experience with MS/MS based de novo sequencing desirable. Previous experience with aSEC, aCEX, aHIC, calorimetry, and light scattering is desirable. Effective communication and collaboration skills are essential. Previous experience working… more
- Merck & Co. (Durham, NC)
- …skills (instrumentation, electrical, plumbing, advanced mechanical, HVAC, and/or multi- stage refrigeration systems).5 Years GMP experience including familiarity of ... regulatory requirements in accordance with Vaccine Manufacturing Operations.Good oral and written communication skillsPhysical requirements - Must be willing and able to lift 50 lbs, climb ladders and stairs, work on platforms and equipment above floor level.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diagnostics (CDx) in support of projects within Daiichi Sankyo's Early and Late Stage Development Portfolio. The individual will play a key role in making Precision ... Medicine a reality for patients who are likely to benefit from our therapeutics.ResponsibilitiesLeads CDx project teams for the diagnostic, in full alignment with Global Program Teams (GPT) for the therapeutic, covering all areas from CDx assay development… more
- Catalent (Manassas, VA)
- …communicate all necessary safety processes and procedures throughout each stage .personal initiative. dynamic pace. meaningful work.Visit Catalent Careers to explore ... career opportunities.Catalent is an Equal Opportunity Employer, including disability and veterans.If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email,… more
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