- Merck & Co. (Rahway, NJ)
- …for the clinical /scientific execution of clinical protocol(s). Serves as the lead clinical scientist on the clinical trial team.Collaborates with the ... of clinical data/medical protocol deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members… 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)
- …primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support of projects within ... and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... perform safety surveillance and risk management in partnership with Product Safety Lead (s), Clinical Safety Physician(s), and cross-functional team in support of… more
- Eisai, Inc (Jersey City, NJ)
- …your profile, we want to hear from you. Job Summary The Associate Director , Medical Writing will be the designated Lead Medical Writer for multiple Programs, ... #LI-Remote Eisai Salary Transparency Language:The base salary range for the Associate Director , Medical Writing is from :149,200-195,800Under current guidelines,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead . Essential Functions Serve as ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating...wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute… more
- Genmab (Plainsboro, NJ)
- …essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be responsible for leading the development ... 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)
- …below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct as lead and ... and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert...clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as… more
- Merck & Co. (Rahway, NJ)
- …of, contractors performing various GMP activities supporting the production of clinical supplies with focus on analytical testing. Key activities this position ... integrity and leading cross-functional contractor performance reviews as the quality lead for the oversight platform.- Experience in medical device and/or… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Strategic Planning provides strategic insights ... input and prioritization rankings via presentation of Forecasts/Assumptions/NPVs and comparative Clinical value where possible. Lead BSA Forecasting team members… more
- Merck & Co. (Rahway, NJ)
- …the oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a ... approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …those involving 3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of Company Core Data ... on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either...on timelines or resources, may assist another Global Labeling Lead by managing labeling development or approval for either… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve… more
- Merck & Co. (Rahway, NJ)
- …and lead a team of TA dedicated global and regional directors and associate directors. The Executive Director , Value & Implementation (referred to as EDMA) ... Job DescriptionThe Executive Director , Value & Implementation (V&I), Global Medical and...Global Brand and V&I Outcomes Research leads to define clinical development plans and brand strategies for assigned TAsProvides… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Line management of Senior Global Safety Lead (s), Global Safety Lead (s) and Global Safety Scientist(s)/ Associate within Safety Surveillance. Essential ... and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here, we are building for the future, creating a distinct… more
- Genmab (Plainsboro, NJ)
- … Director , Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions as necessary.Position level ... a clinical study, depending on background and experience.As a lead , reviews CRFs for adequacy and consistency.Supports the establishment and maintenance of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and empower you to shine? Join us as a BST and Clinical Biomarker Lead , Neuroscience, Associate Director in our Cambridge, MA location. _Objective / ... (eg small molecules, antibodies, nucleic acids and more). + BST Lead will support the clinical development of novel therapeutics by developing translational and … more
- Lilly (IN)
- …as needed/appropriate for the local geography. In countries where there is not an Associate Director / Director Investigator Engagement located, the CRL may ... this position is $111,000 - $162,800 **Job Description** The Clinical Research Lead (CRL) is responsible for...+ Country / Regulatory (where required in countries where Associate Director / Director Investigator… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as an Associate Director , Quantitative Clinical Pharmacology Lead in Cambridge, MA, where ... Provides scientific and strategic leadership as the Global or Regional Clinical Pharmacology Lead for multiple projects on Global Program Teams and associated… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This individual is ... including quality, timelines and resources related to the conduct of clinical research studies in accordance with applicable regulations, ICH/GCP regulations and… more
