- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The RoleGenmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... experience in Regulatory Affairs. A solid understanding and experience in oncology drug development is highly preferred. Strong project management skills. Prior… more
- Genmab (Plainsboro, NJ)
- …best, and authentic is essential to fulfilling our purpose.The Role & DepartmentThe Associate Director , Vendor Management, will play a pivotal role in managing ... Managers, Data Managers, Clinicians, vendors) to support the overall development strategyProficient in managing service agreements and vendor contracts.Where you… more
- Genmab (Plainsboro, NJ)
- …implemented, and utilized at a pace never seen before. Join Genmab as an Associate Director , Solution Architecture and Engineering, R&D Digital Products as part ... AI and Digital Technologies at Genmab! With our rapid development and implementation, you'll have the chance to harness...Products Team. This role will be reporting to the Director of Engineering and Solution Architecture, R&D Digital Products.… more
- Genmab (Plainsboro, NJ)
- …our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development and maintenance ... will be within Global Regulatory Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be based in our Princeton,… more
- Genmab (Plainsboro, NJ)
- …to CPL in a timely mannerExecute operational strategies related to drug supply, regulatory submissions, and recruitmentBudget and PlanningAssist in the initial ... development and management of the trial budgetPlan, implement, and...next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody- drug conjugates. To help develop and deliver novel antibody… more
- Merck & Co. (Rahway, NJ)
- …to a Technology Director in Global Engineering Solutions (GES), the Associate Director will be part of a high performing team, accountable ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (Rahway, NJ)
- …with minimal supervision and/or lead QP2 efforts on drug /vaccine development programs, and author or co-author strategic documents. Associate Directors are ... our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across...trials, clinical trial design and Go/No Go decisionsFraming critical drug development questions for optimizing model-informed … more
- Merck & Co. (Rahway, NJ)
- …and Implementation (V&I) Oncology organization, which leads value evidence plan development and execution to inform healthcare decision making.- This position will ... the Oncology programs.- The position reports to the Senior Director responsible for Portfolio Real World Evidence in Oncology...or more assets, including but not limited to antibody drug conjugate assets for cancer treatment.To design and execute… more
- Merck & Co. (Rahway, NJ)
- …of clinical medicine experience-Minimum of 1 year of industry experience in drug development or biomedical research experience in academia-Demonstrated record of ... radically changes the way we approach serious diseases. --The Director will report to an Associate Vice...medicines. Our Oncology medicines span all phases of clinical development (pre-clinical to post-licensure). The Director will… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... Development organization and has oversight over drug development aspects related to clinical pharmacology...effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical industry experience in one or more of the following areas: Drug Safety, Epidemiology, and Clinical Development preferredDaiichi Sankyo, Inc. is ... rare diseases and immune disorders. Summary This position works with the Director , Clinical Study Startup to establish the strategy driving global Clinical Study… more
- Merck & Co. (Rahway, NJ)
- …these requirements across stakeholders.- - Preferred Experience: Engagement with small molecule drug substance (API development programs from early phase through ... contractor quality and technical personnel and will partner with internal development teams on objectives utilizing external contractors including GMP qualification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of results with some supervision. This position contributes to specific aspects of drug development plans with minimal supervision and contributes to documents ... collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to multiple aspects of the development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:Reporting to a Technology Director or Associate Director in Global Engineering Solutions (GES), the Associate ... growing portfolio of Large Molecule, Small Molecule, and Animal Health work.The Associate Director participates in project activities ranging from business case… more
- Merck & Co. (Rahway, NJ)
- … development including regulatory submission and approval processes. Including development drug -device combination product or a medical device component ... Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe and effective… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director of Scientific Nomenclature and Reference Data is responsible for assigning accurate chemical nomenclature to small ... IUPAC and CAS standards and rulesReference DataUtilizing knowledge of the drug development process and of master data principles for small molecules, biologics,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Biologics and Vaccines External Capabilities Associate Director serves as the primary point of contact for all activities associated with ... outsourcing process development and manufacturing efforts from the research and ...and GMP manufacturing (including cell banks, virus seeds and drug substance) in close collaboration with our company's external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible for ... and provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, ... and non-oral portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and… more
- Merck & Co. (Rahway, NJ)
- …Supply Planning (Planning) organization is the key interface between clinical development teams and the operational/executional arms within the business. The Program ... as the lead Global Clinical Supply spokesperson at clinical and development related meetings.- Working independently, the Program Clinical Supplies Project Manager… more
