Associate Director, Laboratory Data Management

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 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.   

Summary:

The Associate Director, Laboratory Data Management is accountable for the end-to-end delivery of laboratory data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and other vendors to ensure high quality of laboratory data deliverables to support drug development processes and global submissions. This position provides leadership within Data Management by partnering with internal and external stakeholders to optimize laboratory data processes, technology, and standards. This position ensures quality delivery of laboratory data for clinical trials, clinical development, and regulatory submissions.

This position develops and proposes strategies for laboratory data ensuring all clinical trials meets quality requirements and best practices. This position serves as a subject matter expert for laboratory data and management of laboratory data management resources. This position requires an excellent knowledge of laboratory data concepts, strong working knowledge of laboratory data processes and industry standards, and technical skills in data received from CROs and vendors. This position requires excellent verbal/written skills, analytical, organizational, and interpersonal skills and works effectively with people at different levels and from different disciplines and cultures. This position requires demonstrated line management experience and the ability to manage/lead people and a variety of projects concurrently.

Additionally, this position possesses advanced knowledge of medical terminology capture and reporting of safety data, pharmacovigilance, industry best practices, and relevant regulatory requirements. This position has experience working within the medical device and/or pharmaceutical industry across complex disease areas, and experience with regulatory submissions and inspections. This position requires skills in working in a fast-paced environment, continuous improvement, project management, change management, and risk management.

Responsibilities:

Leadership, Direction, and Strategy:
- Establishes company-wide laboratory data management strategies and processes in support of clinical development objectives.
- Accountable for lab data management deliverables for all programs meeting quality and time expectations for both in-house and outsourced studies.
- Accountable for laboratory data management procedures and authorships of specification documents to ensure standardization is maintained; develop new standards and practices where needed.
- Collaborates with Lab Vendors (Central Local) for driving lab data planning, data collection, and maintenance activities aligning with Daiichi Sankyo protocol requirements.
- Establishes operational requirements for lab data management, including management of lab vendors, data planning, data collection, and relevant activities aligning with Daiichi Sankyo and regulatory requirements.
- Participate in vendor contract and MSA discussions, strategic vendor selections, and bid defense meetings.
- Provides laboratory data expertise and guidance to the program teams regarding the laboratory data activities and deliverables.
- Accountable for the maintenance and administration of the Daiichi Sankyo standard local lab information Global Lab Analyte Mapping (GLAM) file and standard LNR worksheet template.
- Models and reinforces adherence to Daiichi Sankyo lab data standards to Daiichi Sankyo program teams, ensures consistency in understanding and implementation of lab standards across Daiichi Sankyo programs.

- Is responsible for management of laboratory data management full-time and/or contract staff including planning resource allocation and projections. Performs line management duties (provides feedback, conducts formal reviews, confirms training completion, and assists with career growth) for direct reports; mentors DM laboratory staff.
- Promotes Daiichi Sankyo values and quality workplace culture, collaboration in cross-functional and multicultural settings, and builds and maintains positive relationships with internal/external stakeholders/vendors/partners.

Project Management:

- Accountable for completion of laboratory data management activities under the outsourced and in-house operating models.
- Accountable for the oversight of CROs pertaining to laboratory data management, LNR collection standards, and quality issue management.
- Collaborates with laboratory DM service-providers to scale resourcing according to program needs and maintain internal budget approvals.
- Accountable for maintenance and adherence to laboratory data management documentation and guidance such as DS LNR Worksheet template, Textbook Range Tracker Template, Lab Loader Instructions, and Lab Load Templates.
- Accountable for oversight for Data Management resources, CROs, and vendors to ensure compliance with the program standards, Policies, SOPs, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other relevant guidelines.
- Accountable for inspection readiness of laboratory data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory requirements.
- Participates in audits and regulatory inspections to provide program-level information as needed.

Functional Expertise:
- Ensures adherence to laboratory data processes, methodologies, data standards, and technologies for quality delivery of DM laboratory data services.
- Evaluates vendor Scope of Work and participates in vendor Request for Proposal process, bid defense meeting, and selection of laboratory vendors. Invoice approval if applicable.
- Provides guidance to cross-functional planning to define and set laboratory data management deliverables at the department level.
- Serves as a Subject Matter Expert on laboratory data, technology usage, and disease-specific requirements to DM standards teams and program teams.
- Advise Manager, Laboratory Data Management on complex textbook range and unit requests as necessary.
- Provides laboratory expertise in the resolution of lab related inquiries and issues such as conversion factors, translations, and textbook ranges.
- Approves the resolutions provided in the Local Lab FAQ log for Local Lab team discussion topics, data trends, and escalations. (
- Accountable for inspection readiness of Data Management lab documentation and approval/signature forms in the TMF according to appliable Daiichi Sankyo and regulatory requirements.

Operational Efficiency / Continuous Improvement:
- Provides leadership within Data Management related to laboratory data topics by partnering with internal and external stakeholders to optimize laboratory data management and LNR coll ection processes.
- Leverages comprehensive Data Management and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.
- Applies GCP principles to ensure all laboratory data management activities follow global SOPs, SOIs, and associated guidelines.
- Remains current with and disseminates information about laboratory trends and advancements, emerging regulatory requirements, and technology innovations to optimize Daiichi Sankyo laboratory data processes.
- Develops and maintains networks with thought leaders in Laboratory Data Management.

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

Education Qualifications (from an accredited college or university)
- Master's Degree in life sciences or related field preferred
- Bachelor's Degree in life sciences or related field required
- MLS (ASCP) preferred
- MLT (ASCP) preferred
- Medical Certifications e.g. Medical Assistance, or Medical Lab Technology (MLACS-accredited), or NAACLS-accredited preferred

Experience Qualifications
- Clinical data management laboratory experience and strong knowledge of: LIMS, specimen management, range of biomarkers tested in the oncology setting, latest and advanced analytical tools and assays. Clinical data management experience in a medical device, pharmaceutical company, or similar environment (e.g., CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required
- 4+ years combined experience managing people and initiatives preferred

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.