- Novo Nordisk Inc. (Plainsboro, NJ)
- …working procedures, quality, and output. The Strategy Director serves as the clinical development strategy lead for pipeline projects. This role will ... Development , Medical, & Regulatory Affairs (CMR), Commercial Strategy & Marketing, and the Global organization...Relationships This position reports directly to the Executive Director, Clinical Development Strategy (CDS) and… more
- Genmab (Plainsboro, NJ)
- …with the Global Regulatory Lead(s) on a compound in late-stage development to implement the US regulatory strategy for multiple new indications. ... Global Regulatory Team, Labeling Working Groups, Launch Teams, Clinical Trial Teams, and other cross-functional teams as required...relevant. Support global regulatory lead and labeling strategy lead in development of the Company… more
- Genmab (Plainsboro, NJ)
- …organization.In this role, the regulatory leader will be primarily responsible for the development of global (and US) regulatory strategies (depending on the ... time per our hybrid policy.ResponsibilitiesReporting to the Team Lead of Regulatory Strategy , Global Regulatory Affairs, the key responsibilities include but are… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is searching for an experienced Director, Global Clinical Drug Supply to be part of Global ... the planning of operational excellence, strategic planning, and innovation implementation for the Global Clinical Drug Supply team. The individual will have the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Responsible for overseeing and managing various aspects of operational activities within Clinical Development & Operations (CDO). Takes ownership to deliver upon ... and optimization of organizational resource allocation. Relationships Reports into Clinical Development & Operations (CDO) Director/Associate Director. Establish… more
- Genmab (Plainsboro, NJ)
- …current US and global regulations and guidance as they relate to global labelingUnderstanding of clinical development of novel biologics products, ... our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/Associate Director will be responsible… more
- Merck & Co. (Rahway, NJ)
- …consultation or operations support needsEnsure an exquisite partnership with Global Clinical Trial Operations, Regulatory and other Development Sciences and ... Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end'… more
- Genmab (Plainsboro, NJ)
- …to be our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery ... of a single or multiple clinical trials from strategy outline through to...regulatory submissions, and recruitmentBudget and PlanningAssist in the initial development and management of the trial budgetPlan, implement, and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Clinical Supply (GCS) organization, within our Research & Development (R&D) Division , is accountable for managing the 'end-to-end' ... integrated clinical supply chain across all of the R&D portfolio...as such, will actively participate in adapting the GCS strategy and priorities to ensure GCS is able-to always… more
- Merck & Co. (Rahway, NJ)
- …new or marketed Oncology medicines. Our Oncology medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage ... Job DescriptionOur company is a global health care leader with a diversified portfolio...the entire cycle of clinical development , including study design, placement, monitoring,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and oversees its tactical execution Oversees and leads pricing and contracting strategy , playbook, and guideline development for all new product launches ... Global Market Access to develop pricing scenarios and strategy for all pipeline products starting in Phase II...across the franchise Leads the optimization of the contracting strategy and roadmap development for the Commercial,… more
- Merck & Co. (Rahway, NJ)
- …Scientist (Executive Director) and Product Development Team (PDT) lead, Oncology Global Clinical Development , has primary responsibility for the planning ... will manage the entire cycle of clinical development , including development strategy , study...lead may:-Manage Directors and/or Senior Directors responsible for Oncology Global Clinical Development projects.-Supervise the… more
- Genmab (Plainsboro, NJ)
- …entire spectrum of drug development at Genmab, from Discovery to Late Clinical Development and beyond.The Head of Clinical Pharmacology & Quantitative ... CPQS in the Translational and Quantitative Sciences Leadership Team and lead strategic development of pre- clinical and clinical pharmacology strategies for… more
- Genmab (Plainsboro, NJ)
- …the needs of the US healthcare market through collaboration with US Commercialization, Global Medical Affairs, Clinical Development , Regulatory, and other ... development and execution of the US Medical Affairs strategy that is aligned with the company's goals and...expert in both internal and external venues including the US/ Global cross-functional teams, clinical development … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …specified therapy area preferred HCP marketing experience leading brand/therapy area strategy development and driving impactful customer experiences is required ... management and strategic collaboration HCP KOL marketing experience leading brand strategy development and driving impactful customer experiences is required… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish and manage relationships with external partners relevant to the strategy , design & implementation of clinical trials improvement/innovation projects ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...relationships positively with multiple internal stakeholders relevant to the strategy , design & implementation of clinical trials… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …trainers and knowledge management staff. Closely partners with line leaders, Global Development key stakeholders, HR organization in understanding, designing ... and adult learning KOLs as required. May also provide input or implement global Development and R&eD training initiatives. Essential Functions Responsible for… more
- Merck & Co. (Rahway, NJ)
- …Directors The position will require: Outstanding leadership in market assessment, product clinical development , product strategy , market development , ... Leader engagement execution, competitive strategy , target product profile development , health authority interactions, global regulatory filing strategy… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Clinical Data Science & Evidence (CDSE) department of NNI focused on clinical informatics tools development to support the CMR organization. This individual ... will serve as a subject matter expect on clinical and medical informatics software and system development...strategy , portfolio, and product strategies as well as Global strategies. Drive understanding and appropriate use of … more
- Merck & Co. (Rahway, NJ)
- …and serves as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working independently, the Program Clinical ... Job DescriptionThe Global Clinical Supply organization is accountable...Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms… more
