- Merck & Co. (Rahway, NJ)
- …research activities involving investigational compounds in Immunology. With a focus on late-stage development , the Senior Clinical Director will manage the ... to the development of new compounds The Senior Clinical Director may: Oversee the ...development projects; and assist the Associate Vice-President/Vice-President and product development team lead in ensuring that… more
- Merck & Co. (Rahway, NJ)
- …development plans from the ground up. They will also be responsible for guiding Product Development Team Leaders and Clinical Directors within their group ... input into research and business development priorities and prioritization of clinical assetsMay serves as the senior liaison for relevant stakeholders in… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Senior Specialist, Clinical Literature MonitoringProvides pertinent and timely information on our Company's products and ... from the world's biomedical literature in support of regulatory, clinical research, marketing, and legal functions.- Plans, organizes, monitors, coordinates,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under IST; Obtains cross-functional alignment ; Leads development and execution of Product Development Plan and clinical development strategy; Leads ... of developmental and regulatory strategy in collaboration with Regulatory Affairs; Drafts clinical development plans, protocol profiles and sections of key… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced MD to serve as Senior Director or Director, Clinical Development . Title and salary commensurate ... contributes and authors presentations, publications, posters, etc. Strategically leads clinical development , product maintenance and optimization… more
- Insmed Incorporated (Bridgewater, NJ)
- …The ideal candidate will possess a deep understanding of the pharmaceutical development process from pre- clinical development through life-cycle management ... new chemical entities.ResponsibilitiesResponsibilities:Acts as an analytical SME for internal product development using analytical techniques including but not… more
- Aequor (Thousand Oaks, CA)
- Remote Copy of AMAGJP00012547 Scrubbed resume attached Regulatory Writing Senior Manager ln this vital role role you will serve as the functional area lead on ... product teams, lead writing activities for complex ...oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols,… more
- Merck & Co. (Rahway, NJ)
- …potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned ... The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the FDA to providing medical education and collecting data to support efficacy and new product development , CMR is involved. The one thing that keeps us all ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...the fellow will gain valuable experience in observing the development of product strategy, engaging with cross… more
- Merck & Co. (North Wales, PA)
- …health. This position supports statistical programming activities for late stage drug/vaccine clinical development projects. This may include leadership of one ... of statistical datasets that support multiple stakeholder groups which include clinical development , outcomes research and safety evaluation. The position… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development , an organization dedicated to the effective strategy, design, ... are consistent with CDP and aligned to achieve the Target Product Profile (TPP)- Development of clinical sections of trial-level regulatory documents (eg,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionResponsibilities:Support statistical programming activities for clinical development projects.This may include leadership of one or more ... execute statistical study and report deliverables ranging from individual clinical trials to world-wide regulatory application submissions.Design and maintain… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …expert knowledge on safety biomarkers that might be used in preclinical and clinical development by closely collaborating w Research and Precision Medicine. ... This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to...candidates by the start of the FIH trial (DP1).- Clinical Development and Post Marketing: Consult with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... mindset and culture through partnering with stakeholders to streamline the product lifecycle process and develop risk mitigation strategies. Provide quality… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Senior Medical Director of Gene Therapy will develop, implement, and lead the ... this fits within the overall company strategy and there is cross functional alignment. Development and execution of MA plans: ensure that strategy is reflected in… more
- Lundbeck (Bothell, WA)
- …determine the potency of drug product for early through late-stage clinical development programs. The successful candidate will have a thorough understanding ... & Validation Team.The Lu-SBP team leads and supports the development of new product candidates from cell... development programs (from early to late phase clinical development ) Author and review SOPs, … more
- Lundbeck (Miami, FL)
- …major airport. Territory consists of Florida, Georgia and Puerto RicoSUMMARY: The Senior MSL, Neurology will apply advanced field based medical and scientific ... Executes on MSL goals and objectives in alignment with Medical Affairs product plans Applies advanced medical and scientific experience, subject matter expertise,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees early-stage trials, such as global clinical development program for multiple product candidates with one ... and Research programs for development of early clinical studies. Provides senior level clinical...senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Skills and coaching for progressive skills development ; Assessing and training product knowledge and clinical selling; Teaching and coaching managed care ... disease state and/or product knowledge, and/or selling skills. Responsibilities: Product Training Development : Partner with stakeholders to develop and… more
- Tris Pharma (Monmouth Junction, NJ)
- … and other strategic initiatives. This includes, but is not limited to: Research, Product Development , Clinical Development , Regulatory Affairs, CMC, New ... knowledge of pharmaceutical market and experience with opportunity assessment, product development and life-cycle management strategies Demonstrated proficiency… more
