Senior Director, Clinical Lead - Neuropsychiatry

Johnson & Johnson (J&J) is seeking a Senior Director, Clinical Lead - Neuropsychiatry to be located in Titusville, NJ; Raritan, NJ; Spring House, PA; or Cambridge, MA.

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines 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.

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 for the preparation and approval 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.

- 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 oversite 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

- 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

- 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.

- 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.

- 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

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.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.

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

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

Additional Description for Pay Transparency: 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)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off

benefits: -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 period10 days -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