Associate Director, Alliance Management
- Employer
- Daiichi Sankyo
- Location
- Basking Ridge, NJ, United States
- Posted
- Mar 03, 2021
- Ref
- 10684BR
- Discipline
- Clinical, Clinical Data, Clinical Trials, Information Technology, Database Administration
- Hotbed
- Pharm Country
- Required Education
- Bachelors Degree
- Position Type
- Full time
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
Job Summary:
The Manager, CRO Alliance Management - Specialty Vendors, contributes to the evaluation and qualification of new specialty vendors and monitors the processes and performance of specialty vendors on an ongoing basis. This may include clinical laboratory vendors or vendors providing specialized services such as companion diagnostics, electronic Patient Report Outcomes (ePRO) solutions, imaging, or psychometric assessments).
Responsibilities:
Work with cross-functional team (including clinical operations leaders, QA and IT partners) to evaluate and qualify new vendors including evaluation of systems and processes
Perform ongoing checks of workflow, processes, chain of custody and SOPs during study conduct and/or on an annual basis. Onsite and remote monitoring of vendors to include creation and ongoing review of KPIs/KCIs; CAPAs to resolution; and major process or system upgrades. Proactively identify and mitigate operational risks
Works with study team to troubleshoot quality issues or concerns
Stays abreast of industry trends regarding the new specialty services /solutions and ecosystem of specialty vendors. This includes building expertise regarding specialty vendor companies and their structure, strategies, financials, operating model and recommending / implementing innovative new processes and tools to enhance clinical trial designs and execution
Partner with CRO Alliance Managers to ensure that touchpoints and interdependencies between specialty vendors and strategic CRO partners are analyzed and optimized to ensure seamless integration of all external trial data
Build and maintain relationships and communications with key specialty vendors
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education/Experience:
Bachelor's Degree in life sciences with minimum of 5 years of pharmaceutical or biotechnology industry experience
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.
Job Title
Associate Director, Alliance Management
City
Basking Ridge
Functional Area
Global Clinical Operations & Planning
State
New Jersey
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. In addition to a strong portfolio of medicines for cardiovascular diseases, 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.
Job Summary:
The Manager, CRO Alliance Management - Specialty Vendors, contributes to the evaluation and qualification of new specialty vendors and monitors the processes and performance of specialty vendors on an ongoing basis. This may include clinical laboratory vendors or vendors providing specialized services such as companion diagnostics, electronic Patient Report Outcomes (ePRO) solutions, imaging, or psychometric assessments).
Responsibilities:
Work with cross-functional team (including clinical operations leaders, QA and IT partners) to evaluate and qualify new vendors including evaluation of systems and processes
Perform ongoing checks of workflow, processes, chain of custody and SOPs during study conduct and/or on an annual basis. Onsite and remote monitoring of vendors to include creation and ongoing review of KPIs/KCIs; CAPAs to resolution; and major process or system upgrades. Proactively identify and mitigate operational risks
Works with study team to troubleshoot quality issues or concerns
Stays abreast of industry trends regarding the new specialty services /solutions and ecosystem of specialty vendors. This includes building expertise regarding specialty vendor companies and their structure, strategies, financials, operating model and recommending / implementing innovative new processes and tools to enhance clinical trial designs and execution
Partner with CRO Alliance Managers to ensure that touchpoints and interdependencies between specialty vendors and strategic CRO partners are analyzed and optimized to ensure seamless integration of all external trial data
Build and maintain relationships and communications with key specialty vendors
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education/Experience:
Bachelor's Degree in life sciences with minimum of 5 years of pharmaceutical or biotechnology industry experience
- Clinical operations / data management or CRO management experience including managing interface with, or data from, specialty vendors (e.g., labs, specialty labs, ePROs, companion diagnostics, imaging, psychometric assessments)
- Direct experience working in a clinical or specialty laboratory setting highly desirable
- Understanding of GCPs and quality systems
- Good leadership, communication, and collaboration skills
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.
Job Title
Associate Director, Alliance Management
City
Basking Ridge
Functional Area
Global Clinical Operations & Planning
State
New Jersey