Dir Clinical Study Startup

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology," Daiichi Sankyo research and 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 and kidney diseases, and other rare diseases.

Job Summary

This position is responsible for establishing the strategy and driving the Clinical Study Start-Up activities for PV Safety Operations. This level develops the strategies for SAE Flow Plan and safety report output, reviews clinical study protocols, approves the Clinical Study Oversight Plan, and uploading the TOPS application and TMF activities. This position also leads the team's interactions with global study teams and represents PV Operations in global interactions with CS Physicians and other study team members. This position interacts within CSPV and with CROs to execute the study start up process. This level handles the most complex problems that necessitate escalation from others and makes decisions on highly complex issues, seeking senior management approval for actions that may impact the global team.

This position has strong verbal/written skills, scientific and organizational skills, and interpersonal skills and is able to work effectively with people at different levels and from different disciplines and cultures. This position possesses a working knowledge of clinical operations and relative regulatory requirements.

Responsibilities

• Leadership, Direction and Strategy for Clinical Study Safety Management: Provides PV safety strategies and actions plans for clinical studies with complex study design, safety concerns and implications, and multiple CROs. This position proactively identifies and manages risks at the project and/or study level to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidance, Policies, SOPs and safety reporting guidelines. This position performs final review of the SAE Flow Plan developed by the team members and other study-specific documents including but not limited to Clinical Study Oversight Plans, presentations and documents. Manages a team of 2-3 Associates responsible for coordinating the setup of EDC (Electronic Data Capture) and other related safety applications for clinical studies. This position oversees the TMF activities on behalf of PV.
• PV Operations Leadership on Clinical Study Teams: Represents PV Operations at multidisciplinary study meetings providing guidance on safety operations, oversight of initiatives and trouble- shooting issues. Liaison for CS Physician and Data Management for study related safety reporting; PV Operations SPOC for study teams and oversees staff assignments on various study teams.
• Procedure Development and Management: Identify and assist in process redesign activities to ensure compliance and consistency across clinical study start-up activities. Reviews, approves, and provides input on SOPS, SOIs, and process guides.
• Inspection Readiness: Participates in inspection preparation activities and internal and external audits, when necessary Identifies case processing and related CRO/vendor training needs and reviews case processing project specific training materials.

Qualifications
Education and Experience

• Bachelor's degree in nursing, pharmacy or health care related field; 5-7 years of management experience in PV, minimum of ten (10) years of PV experience, and knowledge of FDA regulations, clinical and safety databases.

Competencies

• Strong strategic thought process to develop strategic plans and provides guidance on clinical study startup activities including standardization of best practices. Applies clinical trial knowledge to influence strategy and promote efficiency and compliance.
• Ability to "influence without authority" global study teams with various functional representation.
• Ability to expertly identify issues independently, thoroughly understand cause and effect, recognizes functional impact, develops and implement timely solutions.
• Expert scientific knowledge is used to provide leadership and to serve as subject matter expert throughout the process.
• Interfaces, collaborates, and negotiates with project and functional leaders to drive results and resolve complex issues.
• Assists in driving timely management decisions, appropriately shifts functional timelines, resources and priorities to address regional needs.

Daiichi Sankyo, Inc., is an equal opportunity/affirmative action employer. All 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
Dir Clinical Study Startup

City
Basking Ridge

Functional Area
CSPV

State
New Jersey