- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Has primary accountability for operational study level time, cost and quality deliverables. Lead the development of the clinical study plan including ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine...Study Team Leader will work closely with the Global Clinical Lead to ensure alignment. CRO, 3rd… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …marketing in developing a commercial strategy include biomarker strategy; Represents Clinical Development as Global Clinical Lead or as Team Leader ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science ... Senior Director level for each respective program. This Clinical Science (CS) Group Lead will be...delivery of clinical studies in late stage development . Lead and manage the multiple late… more
- Merck & Co. (Rahway, NJ)
- …of matter manufacturing, testing, quality and supply processes from late clinical development through commercialization and uses this understanding to ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Development Sciences and Clinical Supply (DSCS) enables Drug Substance, Drug… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …sub-teams, Global Brand Team, and Global Product Team to inform clinical development , commercialization, market access, and other cross-functional strategic ... research areas centered around rare diseases and immune disorders.Summary The Senior Director, Global Oncology Medical Affairs is responsible for developing the… 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 ... Therapeutic Area strategy that will bring forth programs to successful approval and registration. Lead late-stage development for our company's assets in this TA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... Clinical Development Expertise Strategy- In collaboration with the Global Clinical Lead (GCL), if applicable, leads the development and execution of… more
- Merck & Co. (Rahway, NJ)
- … Development Associate Principal Scientist - Device Engineering and Early Development Lead (Associate Director Equivalent)Our company's Device Development ... the drug delivery and combination produce space to:Drive pipeline development . Lead the core engineering technical device...development team(s) supporting individual drug assets currently in clinical development with line of sight to… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …generate brand awareness among HCPs for upcoming launches Thought Leadership Programming: Lead the development and execution of thought leadership programs, ... with us? The Position The HCP / KOL Strategy lead will be a pivotal driver in shaping an...early market education. This role is responsible for the development of the patient advocacy strategy for the various… more
- Eisai, Inc (Nutley, NJ)
- …well as the study statistician for clinical studies. As the statistical lead for biomarker development , this individual primarily will be accountable for the ... analysis of human biomarker datasets to inform biomarker identification and validation, clinical development and business strategies. As the study statistician,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The HCP Experience Lead will play a critical role in ensuring the successful execution of brand/therapy ... and monitors adherence to administrative policies and procedures. The HCP experience lead has a team reporting to them potentially inclusive of hcp experience… more
- Lundbeck (Bothell, WA)
- …methods to determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough ... is seeking a highly motivated and experienced individual to lead the Potency Assay group supporting the development... development programs (from early to late phase clinical development ) Author and review SOPs, … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Consumer Strategy Lead will be a pivotal driver in shaping an insights-driven consumer marketing strategy, ... and monitors adherence to administrative policies and procedures. The consumer strategy lead has a team of consumer strategists reporting to them. Essential… more
- Eisai, Inc (NJ)
- …a good understanding of other IT systems for contract management and clinical development .#LI-TS1Eisai Salary Transparency Language:The base salary range for the ... to hear from you. Job Summary The Associate Director, Clinical Outsourcing, will oversee and lead and...Lead the process of Request for Proposal (RFP) development through supplier selection and final contract execution on… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …& Simulation plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design ... and lead study teams to execute Clinical Pharmacology... Pharmacology function. The incumbent will champion model-based drug development as an active team member of clinical… more
- Eisai, Inc (Nutley, NJ)
- …in helping to shape and drive oncology pipeline advancement by coordinating with Clinical Development and Clinical Operations. Essential Functions Work with ... strategies for that therapeutic area.She/He will strategize and execute Phase IV clinical development programs for assigned products.Design and review IIS… more
- Eisai, Inc (NJ)
- …you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, ... and oncology, with a strong emphasis on research and development . Our history includes the development of...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. ... trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs.… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The ...of all sizes to advance new medicines from early development to clinical trials and to the ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management including,… more
