Job Description

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. 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

This position will be the Head of Data Review Excellence in Clinical Science, reporting to the VP, Global Head of Clinical Science. He/she will be accountable for building and establishing the clinical data review standards across early and late-stage asset trials in partnership with Clinical Development and Data Management. The Head of Data Review Excellence will be a member of the Clinical Science leadership team and will have people management responsibilities. Within Clinical Science, he/she will partner with the CS Group Leaders and Asset Leaders to establish and standardize data review guidelines, data review tools including listings, patient profiles and other documents to enhance data quality efforts. He/she will serve as the CS primary point of contact and advisor to cross-functional partners for data quality processes, enhancements and workstreams (e.g. IDRP), including but not limited to Data Management and Programming, Clinical Development, Biostatistics and Clinical Operations. Additionally, the Head of Data Review Excellence with his/her direct reports will be responsible for developing the content for data review training materials for Clinical Science and other functions as needed. He/she will partner with training leads on the strategy and execution of the roll out and maintenance of data review trainings globally, including change management and stakeholder management and on-going maintenance of global program.

Responsibilities:

* Accountable for building and establishing the clinical data review standards across early and late phase trials in partnership with Clinical Development and Data Management. Key deliverables include but not limited to:

* Review platform: Establish standard data listings and clinical data review guidelines that can be applied across studies, as well as indication or study specific listings that can be applied per protocol to facilitate ongoing data review. The objective is to create a minimum standard for Clinical Science data review across early and late development trials.

* Patient Profiles Clinical Data Review Rules (CDRR): Establish custom per patient data display and clinical data review rules per protocol for ongoing data review. The objectives are to establish a common standard across reviewers to enable per patient milestone data freezing.

* Dry Run TLFs: Establish a practice and process for Clinical Science to conduct ongoing dry runs of topline subset and all TLFs to optimize table design, to facilitate ongoing cleaning, and to allow milestone freeze and locking.

* Blinded Independent Central Review (BICR) profiles locking: Establish per patient radiology (or other central vendor) profiles in alignment with charter, review and freeze data, and send to BICR on a rolling basis. At study inception, ensure tight alignment of the protocol endpoints, the BICR charter, the BICR profiles, and the CRF design.

* Milestone locking: Define key milestones to clean and soft lock (e.g., screening, dosing, xx-day treatment assessment).

* Protocol Deviation Plan: Partner with Clinical Operations and Clinical Development to prospectively establish clear criteria for protocol deviations, incorporate surveillance checks for deviations into the CDRR for every defined deviation and consider integrating an auditable data collection and review system into EDC.SAE Narrative Review: Comparison of the drug safety narrative text against key fields in the clinical database to ensure that both databases are aligned and that the most substantive data is also in the clinical database.

* Coding pre-review: Establish the expectation for CS monthly pre-reviews of all coding to ensure consistency in manual coding decisions and escalate problematic cases and final approval to the medical monitor.

* Case Report Form Library and Design: The Head of Data Review Excellence will represent Clinical Science on Standard Form Committees within RD especially for CRF design at the disease and study level.

* Data Safety Monitoring Board (DSMB): Clinical Science to be included in DSMB charter writing, table design, slide deck preparation, case summaries and especially data cleaning preparations. CS should formulate a plan to clean data specifically for these meetings, and dry run TLFs should be prepared periodically as programming resources allow.

* Create a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) direct reports and/or professionals in department with specific knowledge, process and procedures. Sets clear job expectations, provides regular feedback, conducts timely Performance Plan reviews, identifies performance challenges, creates action plans, and monitor the effectiveness of those action plans. Complete Career Planning and competency assessment to ensure professional development of department members.

* Ensure that Clinical Science is maintaining up to date knowledge of all-important advances within oncology and hematology through scientific literature, attendance at critical meetings and relationships with Key External Experts (KEEs). Contributes to clinical/scientific training of relevant DS stakeholders on the disease area and compound/drug. May serve as speaker for program/franchise/scientific training.

* Contribute to RD wide initiatives, global education, and process development projects, as required. May serve on or lead global initiatives (e.g. process improvement, training, SOP development, etc.) and represent the function on various leadership teams and committees.

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)

* PhD or equivalent preferred

* PharmD or equivalent preferred

* Master's Degree or equivalent preferred

* Postgraduate training in oncology or related specialty, or equivalent preferred

* Bachelor's Degree required Experience Qualifications

* 10 or More Years with PharmD, PhD and relevant clinical oncology experience preferred.

* 10 or More Years with master's degree and relevant clinical oncology experience preferred.

* Expertise in clinical data review and establishing data review standards in an organization required.

* 20 or more years, with bachelor's degree and relevant clinical oncology experience preferred.

Travel Ability:

* To travel up to 30% In-house office position that may require travel (global).

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.

Apply Not ready to Apply?