Associate Director, Regional Site Management in Basking Ridge, NJ at DSI

Date Posted: 3/26/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

Job Summary:

The Associate Director of Regional Site Management will be in the US and may support studies or programs globally. The individual will be responsible for ensuring the successful delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director, Regional Site Management will collaborate with key internal contacts across Clinical Development, Medical Affairs, Quality Assurance and other DS organizations in support of both clinical studies/programs but also the clinical sites and institutions that conduct DS clinical trials with a focus on oncology. Domestic and global travel up to ~60-70% will be required.

Responsibilities:

CRO and Quality Oversight

Support study teams and clinical trial sites in tracking CRO(s) performance to ensure adherence to scope of work within timelines. Specifically track short-term operational study timelines and monitor operational performance metrics trough the life of the study; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans.
Monitor study budget against trial progress and bring deviations to the Delivery Lead (Director/Assoc Director). Review and approve Vendor invoices, including investigator grants and pass through costs.

Provide oversight of the CRO to ensure compliance with Daiichi Sankyo’s quality measures. Contribute toward the creation of the Quality Oversight Plan (QOP) and take a leadership role in ensuring study team adherence to the QOP. Specifically conduct quality oversight monitoring (CROOM) visits as outlined in QOP. Ensure review and documentation of CRO-generated reports such as trip reports, protocol deviation reports, and analysis of site metric reports. Be able to identify areas of concern and either resolve, propose solutions, or bring to the attention of the supervisor. Coordinate and liaise with Daiichi Sankyo QA on audit activities.
Support QA and regulatory site inspections.

Site and Study Oversight

Expedites the pre-study and study initiation processes including support of Pre-Study Evaluation and Site Initiation Visits in collaboration with Study Managers and/or CRO CRAs, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.

Critically reviews and analyzes site activities through targeted risk-based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable SOPS.

New Site/investigator Identification; Establish and Enhance Site Relationships
  • Identifies, evaluates and recommends potential investigators/sites on an on-going basis within assigned region.
  • Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders
  • Align recommendations with MA, Clinical Operations and Clinical Development
  • Provide site due diligence assessments as required
  • Support development of Operational efficiencies at sites
  • On an as needed basis, Associate Director, regional site management may evaluate output from Trial Feasibility & Site Identification and provide feedback or due diligence on an identified site/center.

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 7 of years’ experience (3 years’ experience with Masters; 2 years with PhD or PharmD)
  • 3-5 years of advanced site monitoring/management in support of complex, oncology clinical trials across the development spectrum (Phases 1-3)
  • Knowledge of ICH/GCP 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 expertise while exercising excellent judgment and decision-making 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.