- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... Facilitate pull-through of the disease area strategy through collaboration with clinical development team (ADC portfolio plus emerging pipeline assets) and key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of CRO; ... of key submission documents; Point of contact for interactions with regulatory-agency clinical reviewing divisions on clinical matters; Represents Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective Serves as a primary source of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to the effective strategy, design, execution, and interpretation of Oncology clinical trials. Position Summary / Objective: Serves as a primary source of medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Publications, Medical Slides, and other related projects). Collaborate with Medical Director responsible for Communication Strategy and Medical Program ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' ... externally sponsored clinical research (ESR)...outcomes, addressing potential issues proactively and ensuring adherence to timelines. Program Leadership: Lead and manage multiple research programs, demonstrating… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …initiative in support of these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director , US Head GPM&L. ... execution of the integrated product development plan.Partners with the Clinical Team Leader to ensure a high performing ...the project environment to address gaps that impact the program /project.Manages the planning and use of program /project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non- clinical ... A cross-Oncology Development Medical Doctor position reporting to the Head Clinical Development Functional Excellence. This position complements CSPV and GMA efforts… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …processes, and on Joint Alliances.Assess and articulate regional interdependencies, program regulatory risks, and opportunities in the development of global ... acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CM&C and other appropriate groups… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Merck & Co. (Rahway, NJ)
- …and increased integration of Chemistry Manufacturing & Controls (CMC) and Clinical strategies.- Position Description/Summary: The Associate Director , Project ... Chemistry Manufacturing & Controls (CMC) development plans.Under the guidance of the Director & Portfolio Lead, the core responsibility of this individual will be… more
- Merck & Co. (Rahway, NJ)
- …to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their ... new therapeutic area for our company; where no regulatory guidance exists; where the program is extremely accelerated; is an Alliance program ; there are multiple… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Merck & Co. (Rahway, NJ)
- …decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of ... pharmacometricians.The Director -Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating advanced pharmacometrics… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team based in ... therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo CAR-T cell therapy... to lead our in vivo CAR-T cell therapy program . If you're passionate about advancing groundbreaking treatments and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and the data governance processes surrounding these capabilities, and the data governance program in general. This role will help support the overall data governance ... privacy, legal, compliance, IT security, etc.Responsibilities- In conjunction with the Director of Data Stewardship, Cataloging and Process, develop implement a data… more
- Novo Nordisk Inc. (New York, NY)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position Builds relationships and demonstrates the clinical outcome and benefits of Novo Nordisk Inc., (NNI) products. Educates and… more
