Vice President, Head of Neuropsychiatry Clinical​ Development

About the role

The VP, Head of Neuropsychiatry (NP) Clinical Development is accountable for strategic leadership and oversight of all Neuropsychiatry related clinical programs and clinical development activities from Phase 2b through the end of Phase 3. Certain phase 4 studies may also be in scope.

Responsibilities

• Core member of the Disease Area Leadership Team (DALT) and the Neuroscience Development Leadership Team
• 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.
• VP NP ensures that CDTs develop thoughtful, integrated asset development strategies and appropriately capture these in the Asset Development Plan document.
• Helps teams identify and addresses the key issues, alternative strategies considered, and key stages of development (with associated GO/NO GO decision points and criteria).
• 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.
• Represents the clinical development group to the rest of the franchise, and to the units of JRD and other Janssen R&D companies.
• Responsible for decisions regarding external presentation of clinical research data, including timing and appropriateness of content.
• 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.
• Provides 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.
• Has financial accountability for the teams for which he/she is responsible.
• Builds and maintains 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
• Strong track record of producing results in a matrix-based environment
• Strong oral and written communication skills
• Fluent in written and spoken English
• 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
• High degree of organizational awareness and understanding of change management
• Strong people management skills, including demonstrated people development
• Strong collaborator, including influencing without authority and conflict resolution skills
• Strong problem-solving skills for developing creative solutions and meeting project objectives
• Demonstrated ability for strategic thinking and contingency planning is required
• Strong oral/written communication and interpersonal skills, allowing effective interactions with all levels of the organization
• Solid analytical skills for integrating and interpreting interdisciplinary project information.

Qualifications

Education and Experience

• 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
• Strong track record of producing results in a matrix-based environment
• Strong oral and written communication skills
• Fully fluent in written and spoken English
• 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
• High degree of organizational awareness and understanding of change management
• Strong people management skills, including demonstrated people development
• Strong collaborator, including influencing without authority and conflict resolution skills
• Strong problem-solving skills for developing creative solutions and meeting project objectives
• Demonstrated ability for strategic thinking and contingency planning is required
• Strong oral/written communication and interpersonal skills, allowing effective interactions with all levels of the organization
• Solid analytical skills for integrating and interpreting interdisciplinary project information.

Skills

Skills

• Clinical Development
• Clinical Research and Regulations

Benefits

Benefits

• Medical
• Dental
• Vision
• Life Insurance
• Short- and Long-Term Disability
• Business Accident Insurance
• Group Legal Insurance
• Pension
• 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

Pay

The anticipated base pay range for this position is $258,000 to $476,100.

Schedule

N/A