- Insmed Incorporated (Westerville, OH)
- …mission to transform the lives of patients. They must possess a high clinical aptitude and experience in portfolio selling environment to engage key customers. Along ... field-based role and can be located in or around Westerville, Ohio.Responsibilities Develop, lead , and execute a sales plan with specific goals and targets to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …LeadershipHas primary accountability for operational study-level timeline, cost, and quality deliverables. Lead the development of the clinical study plan ... including critical path activities and interdependencies for assigned clinical stud(ies) utilizing Microsoft Project or equivalent. Lead the creation of the cross… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global ... the Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be...with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with DS standards. The Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd Party Vendor Management and Oversight: ... Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including critical… more
- Merck & Co. (North Wales, PA)
- …of study start up by reducing the time from study initiation to first site ready.Remove obstacles and enable the Global Clinical Trial Organization to focus ... relies on accurate data collected from patients who are part of Clinical Trials. Trial Standards, Trial Design, Trial Data Collections, Trial Data Integrations,… more
- Merck & Co. (Rahway, NJ)
- …to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug Product, Analytical Development, and ... Clinical Supply across all modalities. We are interdependent across...build connections, and work across boundaries. Proven ability to lead the planning and execution of cross-functional strategic change… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … lead statistician on SAP update, as needed. Provides input to Clinical Operations on site issues. Contributes to development of CSR.External collaboration: ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Catalent (Manassas, VA)
- …sourcing and procuring materials, services, and capital for the site . The Site Procurement Manager will lead site procurement team and initiate ... Site Procurement ManagerPosition Summary Catalent is a global,...sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a key member of the General Medicine Global Clinical Development team, the Vice President/ Therapeutic Area (TA) Head's primary objectives will be ... Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA by overseeing… more
- Merck & Co. (Rahway, NJ)
- …Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development (DD) Team designs, ... enabled combination products to achieve safe and effective delivery to their intended site of action.- The DD Team manages the development of the device constituent… more
- Merck & Co. (North Wales, PA)
- …aggregating individual program information to a portfolio viewEstablish robust CMC and clinical stakeholder interfaces to maintain a pulse on all programs within the ... appropriate tools, dashboards, and business systems.Manage cross divisional workstreams and lead or input into improvements to processes / templates that support… more
- Merck & Co. (Rahway, NJ)
- …and digital solutions are implemented, and sponsor technology adoption across site operations to ensure value delivery on agreed business outcomes. Provide ... product (LM/SM/Vaccine), process development, product introduction, commercialization, and Manufacturing ( clinical and commercial).-Extensive Experience in Information and Operations Technology… more
- Catalent (Manassas, VA)
- Supplier Quality Regional Lead Position Summary: Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the ... of the Global Supplier Quality Management team, the Supplier Quality Regional Lead will be responsible for management and leading the Supplier auditors performing… more
- Lundbeck (MA)
- …United States in close proximity to a major airportPOSITION SUMMARY:The Field Medical Lead - Neurology (East) will lead , coach, train, and provide direction ... defined medical strategies and tactics across assigned products. This role will lead either general MSL training or Field Medical insight generation, distillation,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and supports Supply Chain Management with technical issues post first CPV.Responsibilities- Lead and coordinate the Site -Launch activities and associated teams ... or gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking QA Investigations Lead as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Investigations Lead has the responsibilities for providing quality oversight over...production of a personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment.… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Lead QC Microbiology Data Reviewer as part of the Quality team based in Raritan, ... New Jersey. Role Overview The Lead QC Microbiology Data Reviewer is an exempt level...the manufacturing facility utilized for cell therapy products for clinical trials and commercial operations in a controlled GMP… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …needed- Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of ... input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site...and updates of the Investigator's Brochure (IB): author the clinical section and lead the development of… more
- Merck & Co. (Boston, MA)
- …and own Immunology strategy with other TA Heads (Discovery/Late-Stage Clinical Development). Lead key technical reviews for Immunology assets.Conduct ... Immunology strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.-The AVP provides strategic oversight for the early … 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 ... clinical space, determining and implementing the initial ...Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage) Lead key technical reviews for Cardiovascular & Respiratory assets… more
