- Merck & Co. (Rahway, NJ)
- …to the R&D engine that drives our Company's biopharmaceutical business.Position Description: Associate Director , Finance Clinical Development Finance (CDF) ... guidance of the Oncology Clinical Development Finance Director , the Finance Associate Director ...and Alliance Management, Product Development Team (PDT) Leaders, and Clinical Study Managers regarding study … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the Program Lead, you will ... 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)
- …biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) Study Planning and Execution: Provides ... medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. Responsibilities Study Strategy: Provides… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …product(s) or clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and build and review Statistical Analysis Plans (SAPs) and ... development of minimum core product safety requirements for inclusion in Clinical study protocols (CSPs) and Informed Consent Forms (ICFs), for assigned… more
- Genmab (Plainsboro, NJ)
- …and/or as trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and ... and authentic is essential to fulfilling our purpose.The RoleThe Associate Director acts as a statistical expert...Director acts as a statistical expert supporting the clinical development of compounds as compound and/or indication lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... centered around rare diseases and immune disorders. Summary Position leads complex studies in study design, statistical analysis and interpretation of results… more
- Eisai, Inc (Jersey City, NJ)
- …If this is your profile, we want to hear from you. Job Summary The Associate Director , Medical Writing will be the designated Lead Medical Writer for multiple ... #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. (Omaha, NE)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Affairs (FMA), this position has primary responsibility for directing clinical engagement efforts and developing/implementing medical account strategies on behalf… 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 ... promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates...product labeling as it relates to the use of study results in US promotion.Maintain current awareness of evolving… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of all clinical and nonclinical documents for submissions, eg, clinical protocols and study reports, preclinical reports, investigator brochures, application ... MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …a comprehensive understanding of the functional roles within Pharmacovigilance and Clinical TrialsAbility to extract configurable data fields from a study ... protocolProficient in FDA regulations supporting the submission of adverse events for post-marketing and investigative drugs. Understanding of global regulations preferredGood knowledge of Good Documentation PracticesEffectively manages shifting priorities;… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …vendor selection criteria.- Problem solves and negotiates in most service types, studies , and programs- Responsible for the development and management of other ad ... 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
- Merck & Co. (Rahway, NJ)
- …build 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...real-world evidence data generation and coordinates local data generation studies with V&I Outcomes ResearchSupports the Investigator-Initiated Study… more
- Genmab (Plainsboro, NJ)
- …, Programming.Key responsibilities include:Supports and/or leads programming efforts within a clinical study , depending on background and experience.As a lead, ... Director , Programming, and work closely with Data Management, Clinical Programming, Statistics, Medical Writing, and other functions as necessary.Position level… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- … and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix ... clinical studies and programs. As an Associate Director a typical day may include...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …necessary to design and deliver on clinical studies and programs. As an Associate Director , a typical day may include the following: + May function as ... The Associate Director , Clinical Sciences...The Associate Director , Clinical Sciences contributes to the...studies and ensures scientific integrity and interpretation of study data of a clinical development program.… more
- Veterans Affairs, Veterans Health Administration (Fayetteville, NC)
- …Network (VISN 6), Fayetteville, NC VA Medical Center (FVAMC) under the Office of the Associate Director for Clinical Business Operations (CBO) and serves as ... Medical Center. Responsibilities Advises, participates in and assists the Associate Director for Clinical Business...Formal education in an occupation related major field of study , such as business or public administration, with coursework… more
- Frontier Medicines (South San Francisco, CA)
- Frontier Medicines is seeking a highly motivated individual to fill the position of Associate Director of Clinical Operations to help develop the early ... development. The position will report to the CMO. The Associate Director , Clinical Operations will...and ICH GCP + Must have sponsor experience managing clinical studies . + Breadth of scientific expertise… more
- Amgen (South San Francisco, CA)
- …patients worldwide. It's time for a career you can be proud of. **Scientific Associate Director - Clinical Pharmacology, Modeling & Simulation** **Live** ... data science and predictive analytics to support drug development. The Scientific Associate Director will also work collaboratively with other functional areas… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** ** Associate Director , Clinical Pharmacology - Oncology** **_*This is ... and study sites to implement and monitor clinical pharmacology studies . Addresses clinical ...regulations, ICH guidelines, and GCP governing the conduct of clinical studies . Has significant knowledge of pharmaceutical… more
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