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.
- 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).
- 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.
- 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.
- VP NP is responsible for decisions regarding external presentation of clinical research data, including timing and appropriateness of content.
- 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.
- 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.
- VP NP has financial accountability for the teams for which he/she is responsible.
- 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
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
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.
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
- 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
Skills
- Strategic thinker
- Leadership role within a global multi-functional R&D matrix organization
- Strong oral and written communication skills
- Influencing without authority and conflict resolution skills
- Problem-solving skills
- Strategic thinking and contingency planning
- Oral/written communication and interpersonal skills
- Solid analytical skills
Benefits
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Employees are eligible for the following time off benefits: 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 Additional information can be found via the following link: https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.