[Hiring] Vice President, Biometrics @Otsuka Pharmaceutical Co., Ltd.

Role Description

The Vice President, Biometrics is accountable to the scientific and strategic analytical direction and delivery of the Clinical Development portfolio goals in partnership with the cross-functional Development leaders. This role will drive the goals for Biometrics functions focusing primarily on R&D registrational objectives. This role oversees the biostatistics, clinical programming, and clinical data management pillars and through partnership with the pillar leaders, will lead these essential capabilities in an integrated manner that optimizes the delivery of the clinical data strategy.

Reporting to the VP, Data & Analytics and a member of the D&A Leadership Team, this leader will become a driving force of change, scientific expertise, and delivery excellence across the Data & Analytics organization.

Key Job Responsibilities

• Provide leadership, oversight, and technical/scientific direction to the Biometrics organization.
• Deliver on strong scientific engagement and operational excellence.
• Focus areas include:
  • 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, including:
  • Protocols
  • Analysis plans
  • Health authority submission documents
  • Publication materials
• Engage in external scientific interactions, including health authority interactions.
• Demonstrate operational excellence through effective delivery of the Clinical Development portfolio, including:
  • Resourcing
  • Prioritization
  • Timeline management
  • Functional outsourcing
• Participate in Clinical Development portfolio governance and provide insights and strategic direction.
• Contribute to D&A departmental governance reviews of portfolio and prioritization discussions.
• Regularly monitor and report on the operational health of Biometrics using scorecards and metrics.
• Develop and lead the digital approach for clinical data.
• Function as a knowledge base and resource to project teams.
• Model and coach scientific engagement best practices.
• Foster a culture focused on achievement and personal accountability.
• Embrace the strategic use of data in decision-making.
• Build a learning culture within and external to Biometrics.
• Ensure collaborations and communications with key stakeholders.
• Attract, retain, develop, and promote talent.
• Model the balance of innovation and intellectual curiosity with discipline and structure.

Qualifications

• 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.
• Management of a budget, including resourcing and outsourcing.
• Regulatory in-person interaction experience.
• Experience driving large, complex change efforts.
• Exceptional ability to co-create and work cooperatively with various business leaders and stakeholders.
• Excellent oral and written communication skills.
• Effective influencing and negotiation skills.
• Up to 15% travel required based on business needs.

Requirements

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

Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.

Application Deadline

This will be posted for a minimum of 5 business days.