...standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with... .... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.
Responsibilities...
Suggested
...opportunity employer including veterans and people with disabilities.
Summary
The Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration. Responsibilities include...
Suggested
...around rare diseases and immune disorders.
Summary
Senior clinical operational leader accountable for operational planning and execution of... ...with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation...
Suggested
Contract work
For contractors
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Suggested
...oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management and delivery for all...
Suggested
Work experience placement
...responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute...
Suggested
...monitoring and risk management activities, provides insights on current clinical practice and guidelines, reviews and provides written assessments of relevant medical topics, and supports PV Operations' medical review function. This position supports a senior physician in...
Suggested
...well as other research areas centered around rare diseases and immune disorders.
Summary
The Director, Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier planning team and leading all planning activities for Daiichi Sankyo...
Suggested
...Summary
Oversees a number of trials of a multinational program in a specific indication, i.e., multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical function at meetings with...
Suggested
...around rare diseases and immune disorders. Summary
The Director Global Medical Affairs Oncology (GMA), ADC, under the direction... ...execution for assigned projects in collaboration with GMA Clinical Operations and other cross-functional and regional stakeholders.
Provides...
Suggested
Local area
...initiatives within QA and will have the primary responsibility to collaborate with, and support the head of Global QA strategy and operations. In this position, the incumbent will take on organizational responsibilities relevant to drafting global communications for QA,...
Suggested
Work experience placement
...therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
The Director, Clinical Safety, will be a product safety lead or part of a product safety team, and be responsible for overall product safety strategy...
Suggested
....
Summary
The primary responsibilities of the Associate Director, Omni-Channel Marketing is to develop, plan and implement the... ...with problem resolution. Partner with brand teams, key sales, operations and market access personnel, as well as other internal stakeholders...
Suggested
Temporary work
...responsibilities of this position are to create the model-based drug development plan, design, conduct, and interpret Phase 1 (specifically Clinical Pharmacology) studies, support Phase 2/3 studies, represent function on study and project teams, and participate in and contribute...
Suggested
...disabilities.
Summary
The Associate Director, External Data Management, is accountable... ...Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance... ...cross-functional stakeholders (Clinical Operations, Clinical Biomarkers, Precision Medicine...
Suggested
Contract work
...the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical...
Night shift
...rare diseases and immune disorders.
SUMMARY
The Associate Director, Pharmacoepidemiology position provides epidemiologic, methodological... ...manages relationships with internal (CSPV, Regulatory, Clinical, Medical Affairs, HEOR and other stakeholders to ensure expectations...
...Partner
- Provides scientific and technical expertise by collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations, Clinical Leads and Regulatory Liasions to ensure successful implementation of CDx and data collection
-...
Work experience placement
Remote job
...support of these objectives. This position will report to the Sr Director, Group Leader, GPM&L or the Executive Director, US Head GPM&L.... ...the integrated product development plan.
Partners with the Clinical Team Leader to ensure a high performing Clinical Sub-team and to...
...disorders.
Summary
This position will be part of the Quantitative Clinical Pharmacology (QCP) team and support drug development and... ...QCP on internal teams including Clinical Development Operations, Global Project Management, Bioanalysis, and Drug Metabolism to...
Temporary work
...Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or... ...other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to...
...at different levels and from different disciplines and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies within the medical device...
Work experience placement
...safety, generate submission data package, create TLFs to support submission QAs, perform ad-hoc and exploratory analysis requested by clinical team, and support agency response or potential Advisory Committee Meeting
- Develop DSI programming standard template on...
For contractors
...Project Team) as well representing the project team in other DSI governance process (DRF, G-PAD, GROC, GRSC etc.) Interfaces with clinical & pre-clinical groups, Regulatory CM&C and other appropriate group within the company as needed.
Responsibilities
Manages, directs...
...rare diseases and immune disorders.
Summary
The Associate Director, People Analytics will execute and drive the strategic vision... ...success by leveraging data-driven insights to enhance our HR operations and decision-making processes.
Responsibilities
- Strategic...
...around rare diseases and immune disorders.
Summary The Director, Medical Content & Training (MCT) Excellence and Innovation is... ...level of functional excellence by implementing and maintaining operational processes and identifying the latest digital tools and technologies...
...Specialty : RN- Clinic
Job Description
Supports professional nursing practice across practice settings and across the continuum of care to meet the needs of the patient and family Assess patients' conditions, monitor critical vital signs, and perform interventions...
Weekly pay
...Brands to plan management of incoming materials, POA timeframes and priority projects
Provide cross-functional support to Legal Operations as needed Partner with Regulatory Analyst on the submission of all PMRP approved promotional material to FDA as needed ...
...to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.
Summary
The Director of Portfolio Management, Global Project Management and Leadership (GPM&L) has a key role to play in supporting Daiichi Sankyo Research...
...Protocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP...
Contract work