Senior Director, Clinical Lead - Neuropsychiatry

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow.

Our Neuroscience team tackles the world’s toughest brain health challenges including multiple sclerosis, Alzheimer’s disease, Parkinson’s disease, myasthenia gravis, epilepsy, major depressive disorder, bipolar disorder, schizophrenia, and autism. This patient-focused team helps address some of the most complex diseases of our time. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

About the role

The Senior Director, Clinical Leader (CL) is responsible for 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 (CT). The CL leads the team to develop products in a timely and cost-effective manner and is responsible for the clinical development plans (including life-cycle management, geographic expansion, and post-marketing commitments), protocol development, quality execution of clinical studies, preparation and ownership of clinical study reports, and preparation of essential documents for global regulatory filings.

The CL will manage direct reports who are project physicians. Team leadership via matrix interactions also includes individuals from project management, TA strategy, global regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance, clinical supplies unit, 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. The CL is also expected to assist in the leadership of the evaluation of scientific opportunities in the therapeutic area.

Responsibilities

• 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 the 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.

Requirements

• MD (or equivalent) in relevant area with appropriate post-doctoral training and certification.
• A minimum of 5 years clinical research or pharmaceutical industry experience is required, inclusive of a minimum of 3 years of Phase II/III development experience within industry.
• Board Certification or Eligibility in Psychiatry or Neurology preferred.
• A 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 is required.
• 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.

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.
• Clinical Development, Neuropsychiatry, Neuroscience.
• 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.

Pay

The anticipated base pay range for this position is $232,000.00 - $401,350.00.

Benefits

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year.
• Holiday pay, including Floating Holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental Leave: 480 hours within one year of the birth/adoption/foster care of a child.
• Bereavement Leave: 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
• Caregiver Leave: 80 hours in a 52-week rolling period.
• Volunteer Leave: 32 hours per calendar year.
• Military Spouse Time-Off: 80 hours per calendar year.

For additional general information on Company benefits, please go to: https://www.careers.jnj.com/employee-benefits.