- 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 ... processes (SOPs) and software development life cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including the development… more
- Jazz Pharmaceuticals (Palo Alto, CA)
- …candidates will also have proven experience leading a program or function in late- stage drug development, preferably a highly complex and/or high priority ... portfolio of marketed medicines and novel product candidates, from early- to late- stage development, in neuroscience and oncology. We actively explore new options… more
- Merck & Co. (Rahway, NJ)
- …the statistical programming activities for multiple and/or large/complex late stage drug /vaccine clinical development projects.- Accountability predominantly ... statistical analysis methods and clinical data management concepts.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …experience required- 15+ years industry or related experience required- Extensive early/late stage drug development experience ideally including time in role ... such as a Global Project Leader at Sr. Director level or equivalent preferred- Relevant therapeutic experience and proven ability to learn new indications required- Proven global line management expertise; experience of performance management and development… 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...rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring… 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...drive strategies and activities for early and late phase drug development candidates within the team to support overall… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders. Summary This position is responsible for providing project management, drug development expertise to Global Project Teams including strategic development ... project manager in support of a larger, more complex drug development project. As a project manager this position...any therapeutic area and work on projects at any stage of development.As a member of the GMP&L function… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late- stage clinical development. We are building for the future, creating a distinct ... completion of all clinical activities related to DCR-PHXC and other emerging clinical- stage programs Serve as a leading member, or participant, at multiple internal… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. Our team is looking for a strong candidate for the position ... ophthalmic, and inhaled routes of administration. Support both early and late- stage development candidates that will include ensuring screening and development of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Technology Management (mAb, Drug Substance, Drug Product, or New Modality) Lead is responsible ... of technology transfer of the manufacturing processes of (mAb, Drug Substance, Drug Product, or New Modality)...of key meetings to stakeholders and functional areas (ie, stage gates, working group meetings - upstream, downstream, analytical,… 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 ... generating the early clinical development plan and Investigational New Drug applications.Providing clinical development support of business development assessments… more
- Merck & Co. (Rahway, NJ)
- …team enables the translation of preclinical candidates into non-oral drug products.Primary ResponsibilitiesDesigning and developing sterile products for biologics, ... for injectable and ophthalmic routes of administrationSupport both early and late stage development candidates will include screening and developing robust drug … more
- Catalent (St. Petersburg, FL)
- …timely development of new pharmaceutical products utilizing Softgel Formulation/Process drug delivery systems and technologies by carrying out required ... of applicable product development experience required and direct pharmaceutical drug product development experience preferred. Bachelor's degree in Pharmacy/Pharmaceutical… more
- Catalent (St. Petersburg, FL)
- …waste material for pickup by Outside Contractor. Locate materials for QC and stage for inspection. Perform physical inventory count (secondary du ty) Load and unload ... Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving… more
- Merck & Co. (Rahway, NJ)
- …This position will be responsible for technical interrogation of the various drug delivery device technology platforms supporting our company's pipeline to identify ... as the opportunities arise, develop new and novel delivery technologies.These drug delivery device technology platforms are often assemblages of injection molded… 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
- Catalent (PA)
- …MO and Research Triangle Park, NC, as well as SMARTag Antibody Drug Conjugate technology in Emeryville, CA. Leveraging our growing differentiated technology ... the scope, pricing, and timeline of proposals for both new and ongoing drug substance programs and ensure scopes are adequately reviewed before being delivered to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …MA and Plainsboro, NJ. We support programs from early research through late- stage clinical development. We are building for the future, creating a distinct ... submissions, including investigational medicinal product dossiers (IMPD), investigational new drug applications (IND), clinical trial applications (CTA), marketing authorization… more
