Vice President, Biometrics

Key Job Responsibilities

• Provide leadership, oversight and technical/scientific direction to the Biometrics organization.
• Deliver strong scientific engagement and operational excellence, including efficient and effective trial design and planning, stratification and enrichment considerations, analysis planning, modeling and simulation, submission reporting, advisory committee preparation and presenting.
• Provide scientific review of materials, inclusive of but not limited to protocols, analysis plans, health authority submission documents, publication materials, etc.
• Lead external scientific interactions, including but not limited to health authority interactions.
• Demonstrate operational excellence through effective and efficient delivery of the Clinical Development portfolio, including resourcing, prioritization, timeline management, functional outsourcing, etc.
• Participate in Clinical Development portfolio governance and provide insights and strategic direction based on scientific principles, regulatory guidances/precedence and competitive considerations.
• Contribute to D&A departmental governance reviews of portfolio and prioritization discussions.
• Regularly monitor and report on the operational health of Biometrics, through the use of scorecard and metrics reflecting the functional performance of financials, quality and cycle-time.
• Develop and lead the digital approach for clinical data that is generated through traditional data capture mechanisms as well as through digital mechanisms (e.g. mHealth).
• Function as a knowledge base and resource to project teams.
• Serve as a point of escalation and resolution for the Biometrics organization and Clinical Development portfolio.
• Model and coach scientific engagement best practices that enable thought partnership and engender a collaborative environment with robust debate.
• Further the partnership and impact of Biostatistics at Otsuka.
• Foster a culture that focuses on the achievement of goals and personal accountability, through the setting of goals and expectations, the monitoring to plan and the redirection as needed and the celebration of achievements.
• Foster a culture that embraces the strategic use of data into decision making through the demonstration of the value data can provide with essential direction enabling greater business outcomes.
• Build a learning culture within and external to Biometrics, where individuals are provided growth and development opportunities.
• Drive broad knowledge sharing activities through the use of external expert lectures and trainings as well as internal sharing activities.
• Ensure collaborations and communications with key stakeholders to Biometrics.
• Attract, retain, develop and promote talent to build a team with an optimal balance of experience and diverse perspectives.
• As a member of the D&A Leadership Team, model the balance of innovation and intellectual curiosity with discipline and structure.
• Champion value-add change and evolution and inspire and motivate others.

Knowledge, Skills, Competencies, Education, and Experience

• Experience working within the pharmaceutical industry with functional leadership experience of Biometrics or a Biometrics business unit.
• Experience supporting clinical portfolios spanning multiple therapeutic areas and development phases.
• Line management experience with a multi-function organization and extensive experience with the management of managers of people.
• Management of a budget, inclusive of resourcing and outsourcing and discretionary spend.
• Regulatory in-person interaction, e.g. Scientific Advice, Advisory Committee, etc.
• 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 cooperatively 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 15% travel is required based upon business needs.

Educational Qualification

• Doctorate degree is required in Biostatistics or similar discipline.
• Minimum 15 years of industry related experience within the pharmaceutical industry.
• Minimum 10 years of leadership responsibilities required.

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.