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 teamAccountable 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 phasesSolid knowledge of medical and clinical practices with a strong understanding of medical concepts and terminology.Comprehensive knowledge of CDISC standardsFamiliarity with dictionary coding toolsWorking knowledge of Data Management tools and systemsExpert understanding of industry processes related to data, ICH, GCP and Regulatory guidelinesUnderstanding of new drug development processStrong 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 audienceCapacity to remain flexible, frequently re-assessing and re-prioritizing projects based on business needsActive 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 environmentAbility to exercise independent judgment in the decision-making processExperience building data management teams and co-leading or developing initiativesTravel (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.
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; https://www.otsuka-us.com/careers-join-otsuka.
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.
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