- Novo Nordisk Inc. (Plainsboro, NJ)
- …of technical training across all CMR functions, and compliance across clinical development , medical, and regulatory roles/processes/SOPs Develop and implement ... development , effective execution of CMR role-specific/technical training (eg clinical trial-related, patient safety, therapeutic area leads, MSLs etc.) across… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to support optimization of access & reimbursement, clinical practice, product development and registration. The Director serves as a visible PED champion ... method review) Facilitates integration of the US PED strategy into clinical development programs, post-authorization and commercial research activities and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …reward hard work and dedication with opportunities for continuous learning and personal development . Are you ready to maximize your potential with us? The Position ... Responsible for driving best in class solutions while driving budget and program efficiencies. This individual will maintain a high-level of collaboration and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps...study team, external service providers (CROs, vendors, etc.) and clinical sites to ensure all trial deliverables are met… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …therapeutic / franchise area(s). Relationships Reports to the Executive/Senior Director of Value Communication and Contracting Strategy. Interacts frequently in ... Oversees and leads pricing and contracting strategy, playbook, and guideline development for all new product launches within responsible therapeutic area, with… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …research vendors, & budget management. RelationshipsThe fellow will report to the Senior Director RWE during the program and will work closely with all ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps… more
- Tris Pharma (Monmouth Junction, NJ)
- …a leading privately-owned US biopharmaceutical company with a focus on development and commercialization of innovative medicines addressing unmet patient needs. We ... have an immediate opening for a Head, Medical Science Liaisons (MSLs) / Director , Medical Training for our Pain division. This is a field-based position that… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …guidance for coding of AEs, medical history, and medications when needed Clinical Development Expertise Strategy:In collaboration with the Global Clinical ... Lead (GCL), if applicable, leads the development and execution of the Clinical Development Plan (CDP). Ensures individual protocols are consistent with CDP… more
- Daiichi Sankyo, Inc. (Bernards, 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Sub-team and to drive the development and delivery of the clinical development plan in alignment with the product development strategy.Manages ... these objectives. This position will report to the Sr Director , Group Leader, GPM&L or the Executive Director... and ensures the execution of the integrated product development plan.Partners with the Clinical Team Leader… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the Medical, Clinical Development , Clinical Scientists, Clinical Safety and Pharmacovigilance and Biostatistics program teams to meet needs of ... for delivery of medical coding services for assigned programs, collaborating with program teams, clinical safety and pharmacovigilance, CROs, and partners to… more
- Prime Therapeutics (Trenton, NJ)
- …It fuels our passion and drives every decision we make. **Job Posting Title** Clinical Program Development Director /RPh required- REMOTE **Job ... Description** The Director of Clinical Program Development leads a Clinical team across a given business function. The responsibilities align to a … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …and ensures scientific integrity and interpretation of study data of a clinical development program . The Director leads in a matrix environment as part ... The Director Clinical Sciences, Hematology, leads in the development...The Director Clinical Sciences, Hematology, leads in...may include the following:** + May function as lead Clinical Scientist (CS) for program , and/or as… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- ** Director , Clinical Development ** **Join a Legacy of Innovation 125 Years and Counting!** Daiichi Sankyo Group is dedicated to the creation and supply of ... medical guidance for coding of AEs, medical history, and medications when needed ** Clinical Development Expertise Strategy:** + In collaboration with the Global … more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …(s) for Clinical Data Management (CDM). + Maintains an overview of clinical program (s) status and issues and proactively communicates progress, risks, issues ... and conduct phases of studies. Ensure consistency within the program and development of standard methodologies within...if can:** + Acts as point of contact for clinical program and study level escalation. +… more
- Bristol Myers Squibb (Princeton, NJ)
- …experience or relevant experience in medical quality management, biomedical science, clinical development , or regulatory compliance + Demonstrated strong ... skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution \#LI-Hybrid If you come across a… more
- Merck (Trenton, NJ)
- …alignment with the goals, purpose and mission of our Company's Research Labs, Global Clinical Development (GCD) and GCTO + Positive proven success in people ... **Job Description** The Clinical Research Director (CRD) is the...development of their country / cluster to deliver clinical trials as per global clinical research… more
- Bristol Myers Squibb (Princeton, NJ)
- …of escalation cross functions **Key Responsibilities** + Collaborate with Clinical Science Program Lead and Clinical Development Lead to support ... of clinical trial activities to support the Clinical Development Plan for the disease/indication team...Maintain an advanced understanding of all protocols within assigned Program + Provide scientific and clinical leadership… more
- Takeda Pharmaceuticals (Trenton, NJ)
- … of Clinical Outcome Assessment (COA) endpoint(s) as appropriate for clinical development programs and inclusion of COA endpoint strategy in all ... major deliverables such as clinical development plans, study protocols, strategy slide...long-term disability coverage, basic life insurance, a tuition reimbursement program , paid volunteer time off, company holidays, and well-being… 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
