- Operational StrategyAlign with the Head of Clinical Development Operations or Senior Director, Clinical Operations on plans for successful implementation of studies. Responsible for management of compounds at the program and franchise levels. May represents Clinical Operations on the Strategy and Portfolio or Clinical Sub Teams in their therapeutic area.
- Clinical OperationsEnsure high quality delivery of all studies for which they are responsible. This includes individual studies as well as programs or franchises.
- CRO and Quality OversightResponsible for oversight of all CROs utilized within their therapeutic area. May represent Clinical Operations on the DS/CRO Joint Operating Committee. Work with Process Excellence and Risk Management to ensure oversight plans are in place for all studies falling under their responsibility.
- People and Resource ManagementResponsible for resource management within their therapeutic area. Management requires review of resources against development pipeline to identify areas of resource gaps or excess. Management includes appropriate use of DS employees and contractors to ensure adequate staffing at all times.
- Bachelor's Degree in the Sciences preferred
- 10 or More Years relevant experience required
- 4 or More Years with a MS/MPH preferred
- 4 or More Years with PharmD/PhD preferred
- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
- CRA experience preferred
- Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant. preferred
-
Director, Clinical Operations
2 weeks ago
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our wo ...
-
Director, Clinical Operations
1 week ago
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging ou ...
-
Director, Clinical Operations
3 weeks ago
Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Supervisor, Clinical Laboratory Operations
5 days ago
Northwell Health New York, United StatesSupervises and coordinates the staff and daily activities of staff in a laboratory. Drives results in · a fast-paced environment by providing operational leadership and by interacting with clients, · presenting organizational capabilities, defining scope of work and delivering re ...
-
Remote Clinical Supply Operations Manager
2 weeks ago
The Fountain Group Basking Ridge, United StatesCurrently seeking a · Remote Clinical Supply Operations Manager · for a prominent client of ours. Details for the position are as follows: · Job Description: · Shift: Monday-Friday 1st shift. · Pay: $80-$89.29/hr depending on experience. · This is a temporary assignment tha ...
-
Daiichi Sankyo Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
-
Daiichi Sankyo, Inc. Basking Ridge, United States**Join a Legacy of Innovation 110 Years and Counting** · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class ...
-
Director of Clinical Operations
1 week ago
CareAbout Health Convent Station, United StatesCompany Description · CareAbout Health is a managed services organization (MSO) that provides expert advice, resources, tools, and other support to its portfolio of medical groups and healthcare focused companies. CareAbout Health is helping align incentives to create a world wh ...
-
Director of Clinical Operations
2 weeks ago
Careabout Convent Station, United StatesCompany Description · CareAbout Health is a managed services organization (MSO) that provides expert advice, resources, tools, and other support to its portfolio of medical groups and healthcare focused companies. CareAbout Health is helping align incentives to create a world whe ...
-
Regional Practice Director
5 days ago
IVI America Basking Ridge, United StatesThe **IVI Regional **Practice Director** provides leadership, strategic direction and management to the locations under his/her jurisdiction in accordance with the policies, procedures, objectives and philosophy of IVI RMA. · This position is responsible for enhancing and tangibl ...
-
Regional Practice Director
1 week ago
Reproductive Medicine Associates - RMA Network Basking Ridge, United States**The Position**: · The **IVI Regional Practice Director **provides leadership, strategic direction and management to the locations under his/her jurisdiction in accordance with the policies, procedures, objectives and philosophy of IVI RMA. · This position is responsible for enh ...
-
Daiichi Sankyo, Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Regeneron Pharmaceuticals Inc. Basking Ridge, United States**In a typical day, you will**: · Manage planning and scheduling (team deliverables and timelines) using project managment software such as MicroSoft Project (MSP) and associated project tools according to established best practices · Develop standard framwork, templates, and gui ...
-
Daiichi Sankyo Basking Ridge, United States Full timeJoin a Legacy of Innovation 110 Years and Counting · Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class scie ...
-
Clinical Operations
5 days ago
Evvy New York, United StatesAbout Evvy: · Evvy is unlocking precision women's healthcare through novel, overlooked female biomarkers — starting with the vaginal microbiome. The Evvy Vaginal Health Test is the world's first CLIA-certified, at-home vaginal microbiome test, and tests for 700+ bacteria and fung ...
-
Clinical Operations
1 day ago
Evvy, LLC New York, United StatesAbout Evvy: · Evvy is unlocking precision women's healthcare through novel, overlooked female biomarkers — starting with the vaginal microbiome. The Evvy Vaginal Health Test is the world's first CLIA-certified, at-home vaginal microbiome test, and tests for 700+ bacteria and fun ...
-
Clinical Operations Lead
1 week ago
Everest Clinical Research Services Inc Bridgewater Township, United States Full timeEverest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwide pharmaceutical, biotechnology, and medical device industries. We serve some of the best-known companies ...
-
Clinical Manufacturing Operator
2 weeks ago
Solomon Page Florham Park, United StatesOur client is looking to fill the role of Clinical Manufacturing Operator - Tissue Manufacturing. This position will be located onsite in the Livingston office. Responsibilities: Responsible for the technical manufacture of company tissue and other products Responsible for the te ...
-
Clinical Manufacturing Operator
1 week ago
Solomon Page Florham Park, United StatesWe are looking for a Clinical Manufacturing Operator for an onsite position in Livingston, New Jersey The Manufacturing Operator will be responsible for daily manufacturing of cell products in support of the company's clinical and commercial platforms. Responsibilities: Handle pr ...
-
Clinical Manufacturing Operator
2 weeks ago
Clinical Resource Network (CRN) Florham Park, United StatesOur client is looking to fill the role of Clinical Manufacturing Operator - Tissue Manufacturing. This position will be located onsite in the Livingston office. · Responsibilities: · Responsible for the technical manufacture of company tissue and other products · Responsible f ...
Director, Clinical Operations - Basking Ridge, United States - Daiichi Sankyo Inc.
Description
Join a Legacy of Innovation 110 Years and Counting
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
Senior clinical operational leader accountable for operational planning and execution of FIH, clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level.
Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program
management, leadership, decision-making ability, people management, and organizational skills and expert level written and verbal communication skills.
The role is primarily responsible for Operational Program Strategy and Execution and will have the responsibility of managing multiple direct reports.
Responsibilities
When sitting on a study team, lead the study team to develop a cross-functional, integrated study plan and create initial study budget.
Review study feasibility assessments provided by the CRO(s), lead the CRO selection process and provide input into ARO selection.Validate the study implementation plan provided by the CRO through to study close out and CSR writing.
Ensure the timing of the major study milestones and the associated budget meet the needs of the overall development plan agreed to by the Global Project Team (GPT).Lead site selection and site qualification discussions, kick-off meetings and study team meetings.
Oversee the CRO and provide timely input to ensure that the study is executed according to the agreed project plan.
Complete a study risk assessment and ensure mitigation and contingency measures are prepared and implemented. Actively assess potential risks to the study and propose mitigation plans.Work with TMF Operations to ensure a state of inspection readiness for all TMFs and ensure quality expectations are met.
When sitting on a study team, responsible for management of CRO(s) performance to ensure adherence to scope of work within timelines and budget at an overall study level.
Specifically, track major study milestones and monitor overall operational performance metrics through the life of the study. Identify issues early and propose solutions. Whenever possible, resolve issues that have been escalated or if warranted, take issues to the appropriate governance committee.Create the budget at study start up, and monitor the overall agreed budget against trial progress.
Work closely with internal and external stakeholders to ensure team awareness of the CRO scope of work (to minimize unwarranted change orders) and budget, so both can be managed appropriately.
Provide oversight of the CRO to ensure compliance with Daiichi Sankyo's quality measures.Leads the creation of the Risk Identification and Management Log (RIM Log) and other risk related plans and ensure study team adherence and utilization.
Be aware of and be able to predict deviations or potential noncompliance concerns (at a protocol level, site level, study level) and rapidly resolve or escalate to appropriate Governance Committee.
Analyze CRO performance trends within a clinical study or across several studies and resolve or escalate accordingly.In addition to providing instruction, direction of daily activities in support of goals, the supervisor will conduct a performance evaluation against development goals and career path requirements for their direct reports.
The supervisor should coach and guide their functional and/or direct reports in support of their development needs, and facilitate conflict resolution on their behalfQualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
Experience Qualifications
Physical Requirements
In-house office position that may require some travel (domestic or global). 20% of Time
Travel
Ability to travel up to 20% In-house office position that may require some travel (domestic or global).
_Daiichi 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.
_At the heart of Daiichi Sankyo, Inc. is the fundamental belief that each employee helps shape our success.
We have created an exceptional working environment that values and rewards individual contributions, but we also believe in the power of collaboration.
We provide employees with the training, tools and technology that they need to excel.Our open communication, emphasis on results, and spirit of personal accountability are hallmarks of our corporate culture and ensures that each employee's unique abilities are valued and utilized.
We invite you to consider a career at Daiichi Sankyo, Inc.