Executive Director, Global Clinical Operations Study Management Group Head
$263.25kDaiichi Sankyo
At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.Job SummaryThe Executive Director, Global Clinical Operations Study Management Group Head has leadership and overall strategic oversight of study management and delivery for all therapeutic areas. The role reports into the Global Clinical Operations VP and is accountable for ensuring the clinical trial portfolio and submissions are delivered to time, quality, and cost. The teams reporting into this role must ensure robust strategic and operational planning has been incorporated throughout the governance process, to oversee delivery of projects to plan and to drive standardization and operational excellence across a portfolio of work.Job DescriptionResponsibilitiesPartner with the VP in developing the functional discipline through (i) functional-area leadership, (ii) keeping abreast with latest functional development in the pharma industry, (iii) supporting consistency, coherence, and compliance, (iv) establishing area-relevant standards, (v) encouraging innovation. Build strong relationships with clinical development, clinical sciences, regulatory, biostats, data management, and other key stakeholder peer functions to ensure strong collaboration and early operational input into study design and trial delivery planning and executionEnsure scientific concepts and business priorities are considered to provide strategic global leadership for the clinical operations staff working on clinical programs in scope/portfolio.Close collaboration with Asset and Portfolio Management (A&PM), GCO Clinical Trial Business Operations (CTBO), and GCO Study Optimization to assess and plan for Ph I – III study team delivery and transitions. This includes engagement with feasibility, CTD, RSEM, and site contracts and budget management.Ensure delivery of all operational components of global programs within scope, either through external partners (CRO, ARO, etc) or internal delivery modelsAct as a key point of escalation for issues impacting across program for both internal and external stakeholders. Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders.Support, where needed, internal program/study review meetings preceding governance investment decision meetingsProvide strategic leadership to drive projects and foster a performance driven global cultureAccountable for the creation of an environment that inspires, motivates, and empowers colleagues, influence stakeholders inside and outside of GCO to accelerate clinical development timelines and to create value for patients and the healthcare system.Responsible for maintaining high level of visibility of operational topics among leadership and stakeholders. Functional leadership of up to 10 employees who manage the delivery Ensure capability build, individual development, and performance managementAccountable for resource management within respective portfolio and collaborating with peers to optimize talent in the organization.Ensure the GPT GCO reps are functioning at a high and consistent levelDrives a feedback-oriented cultureResponsibilities ContinuedQualificationsEducation QualificationsBachelor's Degree requiredExperience Qualifications BS/MSA in related discipline, or equivalent work experience required 15+ years industry or related experience required Extensive early/late stage drug development experience ideally including time in role such as a Global Project Leader at Sr. Director level or equivalent preferred Relevant therapeutic experience and proven ability to learn new indications required Proven global line management expertise; experience of performance management and development of Director+ level staff required Proven experience in leading and implementing improvement initiatives, novel technology or techniques in the context of clinical development required Proven change management experience required Proven strategic and innovative thinking required Functional management experience, managing resourcing and budget planning/oversight required Ability to collaborate and establish a well-connected network with other Early/Late Leaders and Clinical Operations Leadership required Demonstrated ability in influencing others in a matrix environment required Awareness of external competitive environment and operational practices required Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global environment required Excellent written and verbal communication skills required Willingness to travel both domestic and international required Proven ability to develop successful collaborations with internal and external partners required Maintains high standards, including a commitment to Daiichi Sankyo values, policies and employment principles. required Travel RequirementsAbility to travel up to 20% of the time. Some domestic and international travel expectedAdditional InformationDaiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.Salary Range:USD$263,250.00 - USD$438,750.00Download Our Benefits Summary PDF
$209.85k - $349.75k
...innovative global healthcare... ...Senior Director, Quality Assurance... ..., Global Clinical Supply is... ...or manage resources... ...various working groups... ...development and execution of regional... ...clinical operations, regulatory... ...represent QA GMP Head in... ...clinical studies to ensure...OperationsContract workFor contractorsLocal area- Associate Director/Director-Global Clinical Pharmacology 1 week ago Be among the... ...Pharmacology, including study design, PK and PK/PD... ...internal teams and external groups such as clinical operations, vendors (CROs, central... ..., as requested by line management Acts as technical lead...OperationsWorldwide
$162.4k - $243.6k
..."be an innovative global healthcare company... ...SummaryUnder supervision of Clinical Science Asset Lead... ...to Clinical Operations and other... ...provide critical study-level support to the... ...for the successful execution of assigned studies... ...(TMCP).With Data Management, co-leads or provides...OperationsWork at office- ...practical and clinically relevant information... ...to the Global Head of Neuroscience... ...insights and executes data generation... ...Senior Scientific Director or Executive... ...Initiate and manage medical... ...lead clinical studies or medical affairs... ...committed to operating with integrity...SuggestedFull timeLocal area3 days per week
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...be an innovative global healthcare company... ...Medicine Global Clinical Lead provides senior... ...Phase 1-Phase 3 studies as assigned.... ...design, feasibility, execution, and... ...and adverse event management, in partnership with... ...regulatory, safety, and operational functions and external...Operations- Arbor Terrace Basking Ridge seeks an experienced Executive Director to lead the community with full P&L accountability, resident-focused service... ...and an active New Jersey CALA license, with at least 3 years in senior living operations leadership. #J-18808-Ljbffr Arbor CompanyOperations
- ...mission-driven group of talented... ...a commercial global leader and pioneer... ...from clinical through commercialization... ...colleagues operating in a flexible... ...Summary : The Director Global... ...provide hands-on execution for ADCTs GCP... ...Provide hands-on management of regulatory...OperationsFull timeContract workWork at officeWorldwideFlexible hours
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...and overseeing oncology clinical trials with a minimum... ...for the successful management of international clinical... ...through clinical study teams and through the... ...functional teams or work groups as well as direct reports... ...presentations before executive staff.Extensive experience...Operations- ...Job Description The Clinical Operations Program Director is responsible to... ...operations to bring clinical studies to life through the execution of one or more... ...strategic thinking, a global mindset and innovative... ...influences all levels of management and cross-functional team...OperationsFull timeWork experience placementLocal areaRemote work
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...OverviewThe Senior Global Medical Affairs Manager will play a critical... ...role in supporting the clinical development,... ...Evidence Generation & Study ManagementDevelop study... ...activitiesEnsure studies are executed to high scientific... ..., Clinical Operation, Marketing, Legal) to...OperationsRemote work2 days per week- Wallenius Wilhelmsen seeks an experienced Procurement Category Manager, Operations & External Workforce. This role owns a global procurement portfolio valued at approximately USD 200 million, spanning MRO materials, equipment leasing, external workforce services, and HR...Operations
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- The Global Campaigns Lead translates Avanade’s go-to... ..., web, and marketing operations teams to create connected... ...teams.Experience managing global or multi-market... ...account-based, buying-group, or signal-driven demand... ...recommendations.Strong executive communication,...OperationsLive inWork at officeLocal area
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...to "be an innovative global healthcare company contributing... ...Committee Office Manager leads evidence generation governance, operational oversight, and... ...process for company-funded clinical studies, expanded access programs... .... Manage the execution of documentation of all...OperationsWork at office- Novartis in East Hanover, NJ, is seeking a product management leader to transform CRM capabilities within commercial operations. The role emphasizes innovation, partnerships,... ..., agile practices, and governance across a global enterprise. #J-18808-Ljbffr Mariforce CrewingOperations
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...to "be an innovative global healthcare company... ...oversight for one or more clinical trialsMatrix management responsibilities... ...Phase 1-3 studies (depending on assignment... ...GCL in planning and executing the overall publication... ...Organization or Cooperative Group partnership, if...Contract work$165.4k
VP & Managing Director, Mid-Sized Pharma Join IQVIA and help drive healthcare... ....IQVIA is a leading global provider of clinical research services,... ...account leadership, and operational excellence to accelerate... ...consistent, high-quality execution and sustainable growth. Acting...OperationsFull timePart timeImmediate startRemote workWorldwide$164k - $282.9k
...more at Job Title Global Medical Affairs Director, Bladder Cancer... ...aspects of the clinical-commercial... ...Medical Strategy and Execution team, Regional Medical... ...of high-level managers and executives... ...knowledge of study methodology, study... ...Clinical Trials Operations Communication...OperationsWork at officeImmediate start$172.5k - $249.17k
...Title: Associate Clinical Research DirectorLocation... ...in shaping and executing clinical... ...Clinical Research Director of immunohematology... ...for: the clinical studies (Sickle cell... ...leadership, and operational excellence, the Clinical... ...of people globally by making drug development...OperationsFull timeWorldwide$129.5k - $163.1k
...Senior Manager, Clinical Data ManagementPTC Therapeutics is a global commercial biopharmaceutical... ...company Standard Operating Procedures (SOPs)... ...of the study objective and company... ...and ensure proper execution of data management... ...Clinical Operations group, biostatisticians...OperationsTemporary workWork experience placementWork at office$93.1k - $285.5k
...looking for Senior Project Leaders/Clinical Program Managers to join our innovative and dynamic group of global professionals dedicated to... ...analytics. This role owns study and or program level timelines... ...and/or clinical operations, clinical R&D experience preferred...OperationsFull timePart timeImmediate startWorldwide- ...Bioanalysis and Biomarker Outsourcing Manager to oversee outsourced bioanalytical and... ...biomarker activities across preclinical and clinical studies, ensuring quality and timeliness. You... ...with Central Laboratories and clinical operations, and #J-18808-Ljbffr Biopharma AsiaOperations
- ...Description The Risk Management Lead (RML) serves as... ...management practices across global clinical trials, partnering closely with study teams and Central... ...of high-quality study execution and regulatory compliance... ...experience in clinical operations, with proven expertise...OperationsFull timeLocal area3 days per week
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...their merit. Job Function: R&D Operations Job Sub Function: Clinical Trial Project Management Job Category: Professional All... ...project teams to accelerate project execution and increase probability of... ...required Experience working in a global matrix organization is required...OperationsContract workLocal areaImmediate startFlexible hours$180k - $210k
Everest Clinical Research (“Everest”) is a full-service... ...statistical and data management center of excellence.... ...our winning team as Director, Clinical Data... ...control clinical data operations to provide complete,... ...with other corporate executives. Maintain strong client...OperationsContract workWork at officeLocal areaRemote workWork from homeWorldwide- ..., Inc. seeks a Research Pharmacist to guide investigational product development, manuals, and DPI for clinical sites. The role blends protocol review, site operations, and aseptic preparation guidance for injectables. You will develop IP manuals, pharmacy manuals, and...Operations
- ...Sankyo, Inc. is seeking a GOMA Governance Review Committee Office Manager to lead evidence generation governance, ensure regulatory compliance, and oversee global oncology review processes across studies and expanded access programs. You will partner with Global Oncology...Work at office
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