- Arcellx (Redwood City, CA)
- …respect a diverse set of views and backgrounds. How You'll Make a Difference As our Senior Director , Clinical Regulatory Affairs, you'll lead and drive ... Arcellx's clinical regulatory approval strategy and implementation and oversee post-approval ...Candidates with less experience may be considered at the director level. Proficiency directly writing submission documents that support… more
- Merck & Co. (North Wales, PA)
- Job DescriptionReports to the Director / Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for ... and approval of all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to ensure that promotional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …direction, acting as a key decision-maker and/or arbitrator on global projects.Interface with clinical and pre- clinical groups, Regulatory CM&C and other ... Oncology) is responsible for providing oversight and formulation of strategy for global regulatory submissions in Oncology in the US, EU, Japan, China, and other… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a full-time permanent Director / Senior Director , Clinical Quality Assurance. This is a ... Job Title commensurate with experience.SUMMARY:Reporting to the Chief Quality Officer the Senior Director of Clinical Quality Assurance provides strategic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and cross-functionally. Additionally, this position possesses advanced knowledge of clinical operations and relevant regulatory requirements. This position ... ability to function as DM SME in internal audits and/or regulatory on-site inspectionsKnowledge of clinical trial operations, clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. ... on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical ...project team members, and to a limited extent with senior management, and outside vendors; works independently for all… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with decision-makers across multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential ... and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …of PK-PD and Pop PK-PD concepts and analysis, phase 1-4 clinical studies, literature, regulatory guidelines, and physiological/pharmacological aspects of ... drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science ... in one or several programs. Partner and collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs, and other RD… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg, response to HAs, briefing book, etc.) in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... with CDP and aligned to achieve the Target Product Profile (TPP)Development of clinical sections of trial-level regulatory documents (eg, response to HAs,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will aid in the construction of clinical development plans, clinical protocols, and in submission of certain regulatory documents. Responsibilities:Develop ... plans, clinical protocols, and in the submission of certain regulatory documents from the translational perspective. Provide translational deliverables (eg data,… more
- Merck & Co. (Rahway, NJ)
- …analysis, regulatory reporting, and publication.Specifically, The Senior Director May Be Responsible ForEvaluating pre- clinical and translational work ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director... regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior /Executive … 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 ... 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)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead Support investigator ... About the Department The Clinical , Medical and Regulatory (CMR) department... Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director ,… more
- Merck & Co. (Rahway, NJ)
- …multidisciplinary team environment with key stakeholders across organizations such as Regulatory CMC, formulation functions, and clinical functions to ensure ... 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)
- …guide the QA review and approval of GLP and GCLP study protocols, clinical study reports, ICFs, external publications, and regulatory authority submissions ... addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key ... within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and ...internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics,… more
- Merck & Co. (North Wales, PA)
- …includes integrating strategic and tactical input from diverse disciplines (eg, clinical , regulatory , market access, manufacturing, CMC, commercial, and other ... & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug Development… more
