- Merck & Co. (Boston, MA)
- Job DescriptionThe Executive Clinical Director (Distinguished Scientist) has primary responsibility for the strategic planning and directing clinical ... investigational compounds in Immunology. With a focus on late-stage development, the Executive Clinical Director will manage the entire cycle of clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing ... plans from FIH to post registration. Responsibilities include the development of Clinical Pharmacology and Modeling and Simulation plans, design and lead study teams… 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
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... support for anticipated promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates to the use of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …safety monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant ... meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)MD with board… more
- Merck & Co. (North Wales, PA)
- …executing late-stage clinical trials across therapeutic areas around the globe.The Associate Director , Advanced Analytics will work with our partners across ... an inspiring mission to achieve new milestones in global healthcare.Our company's Global Clinical Trial Operations (GCTO) organization is primarily responsible for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Job Summary: The Associate Director of Regulatory Writing is a key role responsible for ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… 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 ... producing scientifically accurate, high-quality clinical regulatory documents while adhering to regulatory guidelines. This...and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of ... Global Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring strict adherence to Good Clinical Practices (GCPs), relevant Standard… more
- Merck & Co. (North Wales, PA)
- …the Research & Division organization of our company.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… 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 ... are tracked and ensure implications are assessed and communicated on timely manner- Clinical Development Life Cycle Management Decision Support: Be the key point of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory ... landscape Qualifications: (What are the minimum requirements for the position?) Education :PhD in Life Sciences or in related discipline preferred.MS degree in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and Forecasting - Manages and is accountable for the development and control of Clinical Project Budget in support of Phase I-III clinical studies. Partner with ... meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)- Bachelor's Degree… 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
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to meet the qualifications below with or without a reasonable accommodation. Education (from an accredited college or university)- Bachelor's Degree required- ... preferred Experience- 7 or More Years Outsourcing, health sciences or related field ( clinical trials) required- 7 or More Years Deep experience in pharma procurement… 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 ... to meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)PhD in statistics or… 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 ... meet the qualifications below with or without a reasonable accommodation. Education Qualifications (from an accredited college or university)Bachelor's Degree… more
- Merck & Co. (North Wales, PA)
- … trials and will interact externally with key opinion leaders.Specifically, the Associate Vice President may be responsible for:Evaluating pre- clinical and ... Job DescriptionThe Associate Vice President (AVP) has primary responsibility for...Executive Director , Senior Director , or Director level personnel responsible for oncology clinical … more
- Merck & Co. (Rahway, NJ)
- …approach, driving the development of in vitro-in vivo relationships and preclinical-to- clinical translation in bioperformance of formulationsThe Director will ... oral and non-oral portfolio. Within Biologics and Biopharmaceutics, the Biopharmaceutics Director will influence the strategy, lead activities, and develop a team… more
- Daiichi Sankyo, Inc. (Nashville, TN)
- …preferredPrevious experience in Oncology, clinical research and medical education preferred Principal MSL/ Associate Director MSLExperience ... practice, research, academic or US managed markets preferredPrevious experience in Oncology, clinical research and medical education preferred Must have a valid… more
