Executive Director, Clinical Leader– Neuropsychiatry

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Job Overview

Executive Director, Clinical Leader – Neuropsychiatry; Location: Allschwil, Switzerland.

Key Responsibilities

• Responsible for the development and execution of medical and scientific strategies for late phase compounds (Ph2b/3), and operational implementation, delivered through the effective leadership of a cross‑functional Clinical Team.
• Lead the team to develop products in a timely and cost‑effective manner and be responsible for the clinical development plans (including life‑cycle management, geographic expansion, and post‑marketing commitments).
• Oversee protocol development, quality execution of clinical studies, preparation and ownership of clinical study reports, and preparation and approval of essential documents for global regulatory filings.
• Manage direct reports who are project physicians and collaborate across matrix functions including project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies, data management, medical writing, biostatistics, global medical safety, pharmacogenomics, early clinical development, clinical pharmacology, data science, digital health, global clinical operations, health economics, epidemiology, global medical affairs and other scientific and business related disciplines.
• Assist in the evaluation of scientific opportunities in the therapeutic area.

Essential Functions

• Responsible for the development and execution of the clinical development plan and has ownership for the design of clinical trials and for the content of clinical study reports.
• Leads Cross‑functional Clinical Team; supervises, develops and recruits junior medical staff.
• Molecule responsible physician; responsible for the oversight of medical monitoring/reporting and safety activities; evaluates adverse events (pre and post‑marketing) for relationship to treatment.
• Responsible for overseeing content for the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed.
• Interprets, reports and prepares results of product research in preparation for global health authority submissions and external communication.
• Responsible for assessment of medical publications emerging from the Team and its affiliates.
• Assists Regulatory Affairs in the development of drug/device regulatory strategies and determining requirements for any corrective actions or health authority reporting.
• Acts as medical contact at company for global health authorities concerning clinical/medical issues.
• May act as company spokesperson regarding publication of clinical research findings and presentations to relevant global health authorities and advisory committees.
• Helps explore and evaluate new product ideas to assist in identifying new marketing opportunities.
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling and surveillance.
• Supports early clinical development involving product potential and development for registration.
• Manages the budget for all project related clinical activities.

Education & Experience

• MD (or equivalent) in relevant area with appropriate post‑doctoral training and certification.
• Minimum of 7 years clinical research or pharmaceutical industry experience, inclusive of a minimum of 3 years of Phase II/III development experience within industry.
• Board Certification or Eligibility in Psychiatry or neurology preferred.
• Minimum of 3 years of highly successful managerial/supervisory or related experience.
• Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards.
• Global registration experience strongly preferred, as is experience working or interacting with Health Authorities.
• Experience working in a Matrix environment is required.
• Ability to interface effectively with clinical operations, medical affairs and marketing is essential.
• Required Technical Knowledge & Skills
• Fluent in written and spoken English.
• Working knowledge of the use of Microsoft suite of software products including Excel and Word.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.
• Preferred Skills
• Clinical Research and Regulations, Clinical Trials, Collaboration, Corporate Governance, Data Management and Informatics, Developing Others, Drug Discovery Development, Global Market, Health Care Regulation, Inclusive Leadership, Industry Analysis, Innovation, Leadership, Market Research, Research Ethics, Scientific Evaluation, Scientific Research, Stakeholder Management, Strategic Change.
• Equal Opportunity Statement

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 or expression, age, national origin, disability or veteran status.

We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act.

We are committed to providing an inclusive interview process and are happy to accommodate any reasonable requests for assistance.

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