Director, Data Management - Otsuka : Job Details

Job Summary Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: Otsuka-people creating new products for better health worldwide. Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. Otsuka Data Management is part of the Clinical Analytics department and supports the efficient and effective development and delivery of the clinical pipeline. As a Director, Data Management, you will serve in this leadership role while reporting directly to the Senior Director, Data Management. You will be responsible for line management of Associate Directors, providing direction for DM organization and supporting Otsuka affiliates and Alliance Partners to ensure consistency in data reporting and structure. This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected roughly 20% of the time based on business needs. Remote options will be considered for US candidates. Job Description Oversee the Data Management (DM) Program Leads to ensure resources are appropriately aligned to implement ongoing projects and initiatives. Provide leadership by driving priorities, assigning projects and coaching/mentoring Assoc. Directors. Ensure successful adoption of data processes, standards and best practices across DM team Accountable for strategies and data processes to ensure consistency, compliance, and efficiency of DM team. Lead the development of procedures and processes for data management team. Work closely with Head of DM to prioritize business needs and key data initiatives. Oversee audits/inspections, including mentoring, interview prep and CAPA resolution. Coordinate Global Data Management activities with Otsuka affiliates and CRO Partners. Serve as Data Management Liaison with alliance partners on submissions. Evaluate technologies for continuous improvement and efficiency of DM organization. Provide oversight of project timelines, budgets, and define KPIs and KRIs. Serve as key contact for contracts and budgets with vendors. Provide oversight to CROs and vendors. Work collaboratively with key stakeholders for submissions. Maintain and develop departmental Standard Operating Procedures and ensure staff compliance with all departmental and corporate SOPs. Ensure that appropriate training is in place so that DM staff is adequately and properly trained to effectively perform job requirements. Set performance expectations for direct reports, establish a feedback loop among employee's peers and provide specific and frequent feedback. Participate in new hire process and training/onboarding. Serve as escalation point for DM Program Leads. Qualifications/ Required Knowledge/ Experience and Skills: Expertise in design, conduct and locking of data in clinical trials at all phases Solid knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology. Comprehensive knowledge of CDISC standards Familiarity with dictionary coding tools Working knowledge of Data Management tools and systems Expert understanding of industry processes related to data, ICH, GCP and Regulatory guidelines Understanding of new drug development process Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook) Ability to communicate thoughts/ideas in an unambiguous manner and adjust communication based on audience Capacity to remain flexible, frequently re-assessing and re-prioritizing projects based on business needs Active and effective communication skills with team members - strong oral and written communication and presentation skills. Excellent attention to detail and ability to effectively multi-task in a high paced environment Ability to exercise independent judgment in the decision-making process Experience building data management teams and co-leading or developing initiatives Travel (approximately 40%) Educational Qualifications Bachelor's degree or Master's degree (preferred) with a minimum of 12 years of experience in data management, as well as pharmaceutical industry experience, including 5 years of supervisory experience. MS1 Competencies Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change. Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business. Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders. Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka. Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals. Empowered Development - Play an active role in professional development as a business imperative. Minimum $160,530.00 - Maximum $240,005.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elements may be used to determine actual salary such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. This information is provided to applicants in accordance with states and local laws. Company benefits : comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits. Come discover more about Otsuka and our benefit offerings; . Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer . All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic . If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability . You can request reasonable accommodations by contacting Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf. Please understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment. 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If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (Otsuka ) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.