- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …including KOLs and Principal Investigators. Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for ... NJ. We support programs from early research through late-stage clinical development . We are building for the...make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be...regions- Interact with clinical investigators, academic organizations, co- development partners, and strategic outsourcingCS Group Lead … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clinical trial data on the Vivli data sharing and research portal is current. Lead /co- lead global process development and procedural document drafting, as ... research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …value of assets and the enterprise as well as providing strategic input into clinical trial strategy and regulatory development . With a holistic overview across ... us? The Position The Pipeline and Early Commercial Strategy Lead will be at the forefront of shaping the...strategy for pharmaceutical assets in the early stages of development within the CS&M (Commercial Strategy and Marketing) organization.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... business function and collaborate with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in place for… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of the competitive landscape, market research, historical products, and payer landscape. Lead market development and unbranded activities for the therapy area ... Product Evolution: Oversee product strategy and regulatory activities related to new clinical data or label changes. Lead modification to marketing strategies… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you ready to experiment with us? The Position The Therapeutic Area Operations Lead is responsible for supporting the therapeutic area One Impact Planning process, ... the business. Relationships Reports to the US Integrated TA Strategy Lead . Collaborates closely with cross-functional teams, including sales, marketing, medical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …clear and sustainable platform of evidence generation, design and leadership of clinical development plans, and addressing all regulatory, drug and patient ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… 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
- 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
- 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
- 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …in? Are you ready to experiment with us? The Position The Brand Strategy Lead is pivotal in developing brand level objectives and strategic priorities. They will ... overall brand growth, market share and profitability as well as supporting the development and execution of the marketing strategies to promote brand in alignment to… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategic initiatives. This includes, but is not limited to: Research, Product Development , Clinical Development , Regulatory Affairs, CMC, New Products, ... opening in our Monmouth Junction, NJ facility for a Senior Manager, Business Development .The primary role of...diligence process, and succinctly present findings and recommendations to senior management Lead critical aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …teams on various clinical projects and may function as the Lead Clinical Data Programmer on multiple projects simultaneously. ResponsibilitiesPerform all ... support drug development processes and global submissions as required for clinical trials. These include developing and validating SAS programs for clinical … more
