- Daiichi Sankyo, Inc. (Bernards, NJ)
- …functional group and high-complexity disease work to support critical strategic choices for the clinical program . The DAST Director will collaborate with the ... required- Prior experience in project management or leading change management initiatives preferred- Prior experience in clinical development, Medical… 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. ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to...Study Strategy: Provides the strategic direction to Biostats Data Mgmt & Data Ops for EDC, edit checks, data… 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 (CS) ... will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global...disease area and compound/Drug. May serve as speaker for program / franchise medical/scientific training- Guide the Clinical … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, provides input on ICF creation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and geographic scope. Such trials could be pivotal for submission; Prepares clinical section of regulatory documents; Oversees management and performance of ... of trial, clinical trial plan and contingency planning, Analyzes, updates management on potential risks to study deliverables, Provides input on ICF creation,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated ... a primary source of medical accountability and oversight for one or more clinical trials. Matrix management responsibilities across the internal and external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... of medical accountability and oversight for one or more clinical trials Matrix management responsibilities across the...management of adverse events based upon approved Safety Management Team (SMT) materials- Supports overall program … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaborate with Medical Director responsible for Communication Strategy and Medical Program Management on tracking and management of budget.Support Head ... research areas centered around rare diseases and immune disorders. Summary Director , Global Medical Affairs Oncology Publications works with Cross Functional Team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: The Associate Director will lead the execution and lifecycle management of Global Medical Affairs' externally sponsored clinical research (ESR) ... including IIS and collaborative studies required4 or More Years in a clinical management setting requiredA robust background in navigating complex regulatory… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Director Global Medical Affairs Oncology (GMA), ADC, under the direction of the ... Senior Director , GMA Oncology ADC (Global Medical Affairs team lead...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Clinical Development processes. Job Description:Execute an overarching safety program tailored for AEs from end-to-end: understanding predisposing non- clinical ... clinical factors, diagnosis, effective management during clinical trials and beyond in post approval setting.Responsible for...remains top of mind in the context of patient management in the clinical trial setting and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …position will define and oversee the translational strategy/plan for oncology therapeutic program /s in global R&D. The successful candidate will set goals and ... enumerate key translational hypothesis that will drive scientific decision-making both from non- clinical and clinical translational aspects. In doing so, he or… 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
- Merck & Co. (Upper Gwynedd, PA)
- …and be a valued co-strategist on asset cross-functional meetings: Franchise Teams, Clinical , Outcomes Research, Risk Management , and Commercial Asset Development ... Job DescriptionThe Global Director Medical Affairs (GDMA) Oncology Assets & Pipeline...clinical and scientific value requirements for most geographies Management Participate during relevant Global Medical Affairs Team (GMAT)… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the… more
- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development of robust compositions,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …head). They will coordinate with other TA functions including Medical Directors, Alignment Director , Program Development Director and the Medical Liaison ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...ready to make a difference? The Position The Scientific Director (SD) functions as a subject matter expert to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …identify opportunities for operational improvements and seek agreement through consensus management .RelationshipsReports to an Associate Director / Director ... of the Novo Nordisk Inc., (NNI) Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition… more
- Novo Nordisk Inc. (San Francisco, CA)
- …and community thought-leaders in an assigned territory. The Rare Renal Clinical Account Manager will be principally responsible for driving disease awareness, ... leader in the rare renal marketplace. The Rare Renal Clinical Account Manager (RRCAM) will be responsible for achieving...Novo Nordisk. The role reports to the Regional Business Director for Rare Renal and interacts internally with other… more
- Insmed Incorporated (San Diego, CA)
- …for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Executive Medical Director of Ophthalmology, Clinical Development holds the responsibility ... experiencePreferred: A PhD in addition to the above10+ years of management experience in ophthalmology clinical development.Pediatric experience preferred.Gene… more
