Vice President, Head of Neuropsychiatry Clinical Development

Role Overview

• Core member of the Disease Area Leadership Team (DALT) and the Neuroscience Development Leadership Team
• The VP NP has responsibility for the NP development strategy in alignment with Disease Area Strategies, and for assuring an integrated, efficient, effective and timely implementation of that strategy.
• The VP NP ensures that CDTs develop thoughtful, integrated asset development strategies and appropriately capture these in the Asset Development Plan document.
• Helping teams identify and addresses the key issues, alternative strategies considered, and key stages of development (with associated GO/NO GO decision points and criteria).
• The VP NP working with the Compound Development Team Leader (CDTL) assures that the issues and concerns of the functional partners are addressed so that the clinical strategy and the implementation of that strategy is comprehensive, effective, and highly integrated.
• The VP NP has ultimate responsibility and accountability within NP for protocol design and for final protocols, clinical study reports, and clinical components of regulatory packages/submissions.
• The VP NP represents the clinical development group to the rest of the franchise, and to the units of JRD and other Janssen R&D companies.
• The VP NP is responsible for decisions regarding external presentation of clinical research data, including timing and appropriateness of content.
• The VP NP will work with the CDTL, DAS lead and with functional partners from global medical affairs, health care compliance, legal regulatory, and other relevant groups.
• The VP NP is responsible for final approval of each compound’s risk language working closely with the Clinical Leader, the CDTL, and the Global Medical Safety (GMS) group representative
• The VP NP is responsible for assuring appropriate clinical input and direction for programs, and is expected to provide review and input, from the clinical development perspective, for all programs going for Development Forum discussion and DALT and NSRB (Neuroscience Review Board) approval.
• The VP NP is accountable for providing leadership to the clinical research staff within NP, assuring the high quality of work produced, and that the staff is provided with timely, detailed, and constructive feedback, and that the staff is progressing in their professional development.
• The VP NP has financial accountability for the teams for which he/she is responsible.
• The DH is accountable for business plans (BPs) and executing according to the business plans.
• The VP NP is responsible for building and maintaining a top-quality clinical research unit, staffed with industry-leading clinical research staff.

Requirements

• MD or equivalent, MD/PhD a plus, Board Certification in Psychiatry or international equivalent is preferred
• At least 15 years of professional experience with a minimum of 10 years in pharmaceutical R&D
• Experience of phase late phase study design, execution and interpretation including regulatory filings
• Experience of a leadership role in a multifunctional R&D organization
• Needs to be a strategic thinker
• Experience in a leadership role within a global multi-functional R&D matrix organization; strong track record of producing results in a matrix-based environment.
• Strong oral and written communication skills
• Fluent in written and spoken English
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
• Thorough knowledge of the drug development process is required.
• Familiarity with pharmaceutical portfolio risk management is required.
• Knowledge of global regulatory authority procedures and interactions required.
• Must have a high degree of organizational awareness and understanding of change management.
• Must have strong people management skills, including demonstrated people development.
• Must be a strong collaborator, including influencing without authority and conflict resolution skills.
• Must have strong problem-solving skills for developing creative solutions and meeting project objectives.
• Demonstrated ability for strategic thinking and contingency planning is required.
• Must have strong oral/written communication and interpersonal skills, allowing effective interactions with all levels of the organization.
• Must have solid analytical skills for integrating and interpreting interdisciplinary project information.

Benefits

• medical
• dental
• vision
• life insurance
• short
• and long-term disability
• business accident insurance
• group legal insurance
• consolidated retirement plan (pension)
• savings plan (401(k))
• long-term incentive program
• Vacation – up to 120 hours per calendar year
• Sick time
• up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
• Holiday pay, including Floating Holidays – up to 13 days per calendar year of Work, Personal and Family Time
• up to 40 hours per calendar year