Associate Director, Alliance Management

Location
Basking Ridge, NJ, United States
Posted
Apr 02, 2021
Ref
10684BR
Hotbed
Pharm Country
Required Education
Other
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

 

  • 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