- 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)
- …areas centered around rare diseases and immune disorders.SummaryThis position serves as the Clinical Safety Scientist Lead for a large, late-stage program or ... Risk Management (Signal identification, evaluation, mitigation):This position serves as the Clinical Safety Scientist Lead for a large, late-stage program… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Director (Principal Scientist ), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help advance ... our pipeline and drive our strategic priorities.The Director , Principal Scientist - Regulatory Affairs Liaison...shortest time to approval by global regulatory agencies.Reports to Associate Vice President, Executive Director , or Senior… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are seeking a Senior Director (Sr. Principal Scientist ) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can ... Safety (GRACS) and external to GRACS. Key Functions Reports to Executive Director or Associate Vice President, General MedicineWorks Independently and as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, ... scientific integrity and interpretation of study data of a clinical development program. The Associate Director...may include the following: + May function as lead Clinical Scientist for program, and/or as delegate… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Associate Director , Clinical Sciences...day may include the following: + May function as Clinical Scientist for program, and/or as delegate ... through early and/or late phase development. Reports to the Director , Clinical Sciences Hematology, Clinical ...of Therapeutic area Clinical Scientist + Contributes to program team… more
- Daiichi Sankyo Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. **Summary** This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple ... identification, evaluation, mitigation):** + This position serves as the Clinical Safety Scientist Lead for a large, late-stage program or multiple early-stage… more
- Bristol Myers Squibb (Madison, NJ)
- …and in their personal lives. Read more: careers.bms.com/working-with-us . **Position:** Associate Director , Medical Promotional Review Scientist , ... Neuropsychiatry **Location:** Princeton Pike, NJ or Madison, NJ The Associate Director , Medical Promotional Review Scientist plays a critical role in the… more
- Bristol Myers Squibb (Summit, NJ)
- …pioneer. Join us and make a difference. **Summary/Scope** Reporting to Senior Scientific Director Translational Medicine, the TM Sr. Principal Scientist will be ... late stage TM group. The individual will be responsible for TM and clinical biomarker activities to support drug development programs in multiple diseases in… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Director (Principal Scientist ), Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that can help ... advance our pipeline and drive our strategic priorities. The Director , Principal Scientist | Regulatory Affairs Liaison...to approval by global regulatory agencies. + Reports to Associate Vice President, Executive Director , or Senior… more
- Merck (Rahway, NJ)
- **Job Description** We are seeking a Senior Director (Sr. Principal Scientist ) Global Regulatory Affairs Liaison with a visionary, growth-oriented mindset that ... Safety (GRACS) and external to GRACS. **Key Functions** + Reports to Executive Director or Associate Vice President, General Medicine + Works Independently and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing applications/supplements ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Organon & Co. (Jersey City, NJ)
- … in Organon Regulatory CMC New Products, the Associate Principal Scientist ( Associate Director ) is responsible for Regulatory Chemistry Manufacturing ... & Controls (CMC) aspects of clinical phase through market product registration for the assigned...encompass late-stage development products and commercially approved compounds. The Associate Principal Scientist may also support project… more
- Merck (Rahway, NJ)
- **Job Description** The **Executive Clinical Director (Distinguished Scientist )** has primary responsibility for the strategic planning and directing ... investigational compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical … more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …scientist with significant pharmaceutical/biotechnology sector and/or exceptional academic clinical trials' experience. With oversight from supervisor, works with ... System, Neuromuscular and Muscular Diseases. **As a Senior Medical Director , a typical day may include the following:** +...academic clinical trials (10 years post fellowship clinical and research experience, associate or full… more
- Bristol Myers Squibb (Berkeley Heights, NJ)
- …every treatment we pioneer. Join us and make a difference. **Purpose** The Associate Director , Biostatistics is a core member of cross-functional development ... external partners, medical monitor, protocol manager, data manager, PK scientist , and other members of the study/indication team. **Primary Responsibilities**… more
- Merck (Rahway, NJ)
- …We are seeking an experienced and skilled Cheminformatician and AI/ML data scientist to join the Cheminformatics group within Modeling and Informatics (M&I) at ... that accelerate the decision-making process from hit identification to clinical candidate delivery across different therapeutic areas and modalities at… more
- Merck (Rahway, NJ)
- …and dedicated colleagues while developing and expanding your career. The Senior Clinical Director (Sr. Principal Scientist ) has primary responsibility ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...clinical development projects; and + Assist the Executive Director / Associate Vice President in ensuring that appropriate… more
