- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are ... and quality metrics and share with study team, Operations Program Lead, and Sr. Director for the...or Contract Research Organization (CRO). CRA experience is preferred. Clinical Project Management experience required. Time spent… more
- Merck & Co. (Rahway, NJ)
- …issues, mitigation plans and value realization. Partner closely with IT and its Program Management to ensure alignment across planning and investment.-Set up, ... scientific-related discipline strongly preferredRequired Experience and Skills:--Research, manufacturing, and project/ program management experience in pharma Demonstrated ability… more
- Eisai, Inc (Nutley, NJ)
- …hear from you. JOB SUMMARYThe Director , Clinical Project Management will manage assigned project (s), including program 's strategic direction, integrated ... relate to efficient execution of the development plans. Advanced understanding of clinical trial management , including general understanding of all specialized… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead ... will include but not limited to Group Heads in Clinical Development, Asset & Portfolio Management , Global...the disease area and compound/DrugMay serve as speaker for program / franchise medical/scientific training - Guide the Clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Executive Director , Global Clinical Operations Study Management Group Head ... (v) encouraging innovation.Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management , and other key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Represents clinical function at meetings with health authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership ... diseases and immune disorders.SummaryOversees a number of trials of a multinational program in a specific indication, ie, multiple multinational phase II/III … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams including strategic ... this position is accountable for partnering with the Global Team and Global Clinical leader to ensure effective team operations through meeting management ,… 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
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working ... This opportunity will require a focus on all the clinical aspects of the upcoming HS program ....knowledge of Good Clinical Practices, scientific and clinical methodology, protocol design, project management and… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Associate Director Global Medical Affairs Oncology (GMA), under the direction of the Senior ... Director , GMA Oncology (Global Medical Affairs team lead for...lead for compound), is responsible for assisting with defining compound/ program medical strategies and for leading select medical affairs… more
- Eisai, Inc (Nutley, NJ)
- …to hear from you. Job Summary: As the Americas IT Security and Compliance Director , you play a pivotal role in ensuring the organization's adherence to security, ... business. You oversee business continuity, disaster recovery, and crisis management , while also educating end-users on compliance requirements. Additionally, you… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, 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
- 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
- Merck & Co. (North Wales, PA)
- …role in organization development and building a new team.Reporting to the Executive Director of CMC Integrated Project Management , the core responsibility of ... & team processes and PM skills.Primary Responsibilities: -Portfolio and Project Management (~50%)Responsible for aggregating individual program information to a… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... management of API/Intermediate/RSM manufacturing operations at Insmed's CMOs including tech transfer, process optimization, clinical /commercial manufacturing,… more
- Eisai, Inc (Nutley, NJ)
- …and Clinical Operations. Essential Functions Work with key stakeholders, management , and functional area leads to develop strategic and aligned Medical Affairs ... this is your profile, we want to hear from you.The Sr Medical Director provides medical leadership for medical affairs strategy, planning and supportive tactics… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
