The Senior Director, Head of Clinical Data Management within Clinical Analytics (CA) is accountable to the data management and operations in support of Otsuka’s Research and Development (R&D) portfolio. Execution against the R&D goals will be in partnership with the R&D cross-functional stakeholders. This role will lead and evolve the Clinical Data Management capability that will focus primarily on the collection, ingestion, quality, integrity and governing of the clinical data acquired from the trials within the clinical development portfolio. This role is accountable to optimize the operating model for managing Otsuka’s R&D data, inclusive of implementing a differentiating talent strategy, strategic outsourcing approach and the modernization of the data management tools.

This position will work with Otsuka affiliates, Alliance and CRO Partners to promote consistency in data collection, reporting and structure. She/he will be responsible for direct Data Management operations in support of clinical development activities worldwide, including evaluating and recommending new technologies for implementation to maintain industry standards, ensuring compliance with applicable regulatory requirements, and assessing new SOPs prior to approval and implementation.

Reporting to the VP, Head of Clinical Analytics, and a member of the Clinical Analytics Leadership Team, this leader will become a driving force of delivery and excellence across the Clinical Analytics Team within the Data & Analytics organization. She/he will provide leadership, oversight and technical/strategic direction to the Clinical Data Management organization. A highly functioning Data Management organization would be expected to deliver suitable, essential, high-quality, auditable and indexed data resources with a focus on operational excellence.

She/he will provide leadership to R&D Data Governance which is focused on the clinical development trial data. They will design, operate and evolve the R&D Data Governance based on the inputs and needs of key stakeholders, vendors and broad organizational objectives to ensure needs are met and pain points are effectively avoided or resolved.

In support of a complex R&D portfolio, with a scope including co-development partnerships and affiliate support, this leader will ensure portfolio prioritization is consistent with the enterprise imperatives and that there is the necessary domain expertise within their organization.

She/he will participate in Contract Research Organization (CRO) governance committees.

• To lead and facilitate CRO Data Management (DM) Meetings of Management personnel of CRO Partners.

• Provide feedback on monthly and quarterly basis based upon day-to-day operational issues.

• Provide feedback on quarterly basis from joint development of project team metrics and scorecards.

Operational excellence would be demonstrated through the effective and efficient delivery across the R&D portfolios supported by the Clinical Data Management organization. This includes but is not limited to the resourcing, prioritization, timeline management and functional outsourcing.

Contributes to departmental governance reviews of portfolio and prioritization discussions. Regular monitoring and reporting on the operational health of R&D Data Management, using scorecards and metrics reflecting the functional performance of financials, quality and cycle-time.

Function as a knowledge base and resource to project teams. Serves as a point of escalation and resolution for the Clinical Data Management organization.

Models and coach engagement best practices that enable thought partnership and engender a collaborative environment with robust debate. Furthering the partnership and impact of Clinical Data Management at Otsuka.

Guides and informs the broader R&D and D&A organization to the considerations and opportunities regarding the strategic use of data vendors.

Fosters a culture that focuses on the achievement of goals and personal accountability, through the setting of objectives and expectations, monitoring to plan, the redirection as needed and the celebration of achievements.

Fosters a culture that embraces the strategic use of data into decision making enabling greater business outcomes.

Builds a learning culture within and external to Clinical Data Management, where individuals are provided growth and development opportunities.

Accountable for ensuring collaborations and communications with key stakeholders of Clinical Data Management.

Attract, retain, develop and promote talent to build a team with an optimal balance of experience and diverse perspectives.

As a member of the Clinical Analytics Leadership Team, models the balance of innovation and intellectual curiosity with discipline and structure. Is a champion of value-add change and evolution and can inspire and motivate others.

Knowledge/ Experience and Skills:

• Experience working within the pharmaceutical industry with functional leadership experience within clinical data management/operations organizations.

• Experience supporting development portfolios spanning multiple products, therapeutic areas and development phases.

• Line and performance management experience.

• Vendor management experience.

• Management of a budget, inclusive of resourcing and outsourcing and discretionary spend.

• Experience driving large, complex change efforts and to drive results through influence, persuasion and relationships

• Assesses quickly with a track record of getting up to speed and adding immediate value to new situations

• Exceptional ability to co-create and work collectively with various business leaders and other key stakeholders

• Excellent oral and written communication skills, including the ability to organize, conceptually interpret and clearly communicate material developed collaboratively via the input of multiple parties; translate complexity into the actionable

• Effective influencing and negotiation skills

• Up to 20% travel is required based upon business needs.

Educational and Experience Qualifications:

• Bachelor’s degree is required

• Minimum 10 years of industry related experience within the pharmaceutical industry.

• Minimum 7 years of leadership responsibilities required

• 15 years of experience in data management

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