Associate Director, Clinical Data Management

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

Responsible for managing and overseeing all aspects of data management (DM) for assigned projects, including managing staff, selecting and overseeing DM vendors, supervising tasks performed by vendors, assuring data quality, interfacing with in-house staff in establishing and maintaining global data standards and department procedures.

Essential Functions:

•    Strong understanding of Risk Based Quality Management.
•    High sensitivity to industry trends and the ability to leverage them in business
•    Accountable for all aspects of data management tasks from vendor selection to new drug application.
•    Conducting risk assessments related to data and designing data quality by mitigating risks.
•    Oversee all aspects of data management tasks performed by vendor, which include but not limited to: Review CRF, database and dataset structure, Data Management Plan, Data Review Guidelines and edit specifications; Assure dictionary versions are correct; Request specific project tracking reports; Qualify vendor personnel; Review queries; Oversee change order activities; Perform internal activities associated with database lock at vendor (e.g. SAE reconciliation, dictionary term reconciliation, external vendor’s data reconciliation and document collection).
•    Collaborating with an external vendor to create a Data Transfer Agreement.
•    Interface with internal and external staff: Participate on Project Teams; Review protocols, statistical analysis plans, monitoring guidelines and Clinical Study Reports; Work closely with Medical Monitor(s) to review CRF coding for logic, consistency and medical appropriateness.
•    Assure all clinical data is properly collected, cleaned and formatted, to assure data quality and data integrity for proper analysis and interpretation required for inclusion into reports and regulatory submissions.
•    Work closely with DM vendors to ensure timelines are met and communicate to Project Management as appropriate in order to achieve KPIs.
•    Archival of end-of-study documents as appropriate.
•    Responsible for budget planning for DM-related tasks, department budget planning, and budget performance tracking.
•    Supervise DM staff and manage DM resources
•    Support sub-function head of data management in hiring data managers
•    Negotiate with partner companies to obtain trial data. If there are gaps, develop alternatives to complete the submission materials.
•    Participate as a subject matter expert in Regulatory Submissions and Regulatory Audits.
•    Meet and discuss with Japanese HQ regularly, regarding global Data Management procedures, process and standards.
•    Staying updated on industry trends, proposing new Data Management strategies, and executing them independently.

Requirements:

Education
Bachelor's degree in science, Technology, Engineering, or Mathematics, and/or equivalent knowledge and experience

Experience
•    Minimum 10 years’ Clinical DM experience.
•    Minimum 5 years’ pharmaceutical company experience.
•    Minimum 2 years’ people management experience 
•    Multi Regional Clinical Trial experiences
•    Experience in hematological cancers or bone/mineral studies is highly desirable
•    Subject Matter Expert (SME) in FDA or EMA Inspections is highly desirable.

Technical Skills
•    Strong understanding of regulatory guidelines (and the related issues) (e.g. ICH/GCP) and the connection to DM deliverables (e.g. data quality and data integrity).
•    Strong understanding of Risk Based Quality Management.
•    Good understanding of Medical coding (MedDRA and WHO Drug dictionaries) to check consistency codes and upgrade.
•    Strong familiarity with CDISC (CDASH/SDTM).
•    Good understanding of Computerized System Validation
•    Proficient in systems and tools used in clinical trials (EDC, BI tools).
•    Proficient in Microsoft tools (Excel, Word, PowerPoint, etc.).
•    Basic knowledge of Decentralized Clinical Trials(DCT) and AI(Artificial Intelligence)

Working Conditions:

Normal office environment with prolonged sitting and extensive computer work. Work in the office required at least 2 days a week
There are international calls/meetings once or twice a week.
Requires up to 10% of domestic and international travel

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. (“Controller”), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller’s data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller’s recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 (“GDPR”) as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. 

Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller’s behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union.

Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment.  Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com.

Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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