Director, Regional Site Engagement Management

Location
Basking Ridge, NJ, United States
Posted
Nov 12, 2020
Ref
10549BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
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 Director, Regional Site Engagement will build and direct a global team of Regional Site Engagement Managers (RSEM) responsible for developing regional and site-specific engagement strategies, assisting with site identification/evaluation, helping study teams accelerate study start-up activities and issue resolution during the study, supporting study teams and clinical trial sites in tracking CRO performance at key sites, and establishing and enhancing site relationships. The Director, RESM will develop department goals and strategies; hire, train and develop RSEMs; and prioritize and allocate RESM resources to key sites including defining the type and level of support provided to specific sites according to their needs and to their role in DSI's portfolio. This position will also develop and implement processes to ensure RSEMs effectively coordinate activities across multiple Daiichi-Sankyo functions/roles (e.g., Clinical Development, Operations Managers, Medical Science Liaisons) relating to site-specific strategies and interactions.

Responsibilities:

Develop and implement strategy for the new RSEM organization including global footprint of department staff, clear roles & responsibilities for RSEMs relative to other internal/external partners, criteria for prioritizing and allocating RESM resources to sites, well-defined support models to different types of sites tailored to site and DSI needs, and new technology/systems support requirements (e.g., centralized calendaring, site intelligence data capture)

Create and lead a high-performing global team of RSEMs with including recruiting, hiring, training, coaching and development, and performance management.

Partner with key stakeholders within DSI (e.g., Clinical Development, Operations Managers, Medical Science Liaisons), and CROs to develop and communicate optimized processes for site engagement and site interactions both on a portfolio and individual study level. Monitor and adjust processes based on metrics and pro-actively solicited feedback from sites and other partners.

Work with RSEMs to ensure consistency and effectiveness of site engagement approaches and establish channels for ongoing feedback to capture and share lessons learned and best practices and to ensure continuous improvement

Provide direction and support to RSEM staff on ways to strengthen site relationships, develop integrated site-specific plans and playbooks (including site communication plans, rules of engagement, and guidance on ensuring coordination among site-facing roles), build intelligence, and enhance ongoing operations (eg, expedite site activation and start-up activities, site input into protocol design and feasibility)

Create and maintain a consolidated view of capabilities, capacity, and key contacts at key DSI sites to drive decision-making on site selection and to determine the type of support required to ensure successful trial execution

Implement system to ensure that RSEMs to consistently track and assess CRO performance at key sites through monitoring of operational study timelines and operational performance metrics. Define issue escalation and feedback mechanisms as appropriate

Define and oversee the role of RSEMs in contributing to Quality Oversite Plan, conducting quality oversight monitoring visits, supporting site inspection readiness, and ensuring compliance with applicable SOPs

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Bachelor's Degree in a Life Sciences field and a minimum of 10 of years' experience (8 years' experience with Masters; 5 years' experience with PhD or PharmD)
  • Demonstrated ability to lead functional or project /study teams in a highly matrixed clinical development or clinical operations setting
  • Extensive experience in site monitoring/management in support of complex Phases 1-3 trials, including significant Oncology experience
  • Clinical trial outsourcing experience including experience partnering with CROs
  • Knowledge and understanding of ICH/GCP guidelines and regulatory guidelines/directives
  • Understanding of industry trends (Risk Based Monitoring, Central Monitoring, etc.)
  • Ability to resolve a majority of complex study/site related issues independently using functional Strong leadership, collaboration, communication, influencing, and problem-solving skills in a global cross-functional environment.

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
Director, Regional Site Engagement Management

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey