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 innovate across the full spectrum of healthcare solutions to deliver breakthroughs and profoundly impact health for humanity.

As guided by Our Credo, we provide an inclusive work environment where each person is valued as an individual. We respect diversity and dignity, recognizing merit across our global teams.

About the role

The Senior Director, Clinical Lead – Neuropsychiatry will develop and execute medical and scientific strategies for late-phase compounds (Ph2b/3) and oversee operational implementation through leadership of a cross-functional Clinical Team (CT). This role leads product development in a timely, cost-effective manner, including clinical development plans (life-cycle management, geographic expansion, post-marketing commitments), protocol development, quality execution of clinical studies, clinical study reports, and preparation of essential documents for global regulatory filings. The Clinical Lead manages direct reports who are project physicians and collaborates via matrix interactions with teams across project management, therapeutic area strategy, regulatory affairs, finance, legal, quality assurance, clinical operations, data management, medical writing, biostatistics, medical safety, and other scientific and business disciplines. The role also assists in evaluating scientific opportunities within the therapeutic area.

Locations: Cambridge, MA; Raritan, NJ; Spring House, PA; Titusville, NJ.

Responsibilities

• Develop and execute the clinical development plan, including ownership of clinical trial design and clinical study reports.
• Lead a cross-functional Clinical Team; supervise, develop, and recruit junior medical staff.
• Serve as the molecule responsible physician, overseeing medical monitoring, safety activities, and adverse event evaluation (pre- and post-marketing).
• Oversee content for Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed.
• Interpret, report, and prepare results of product research for global health authority submissions and external communications.
• Assess medical publications emerging from the team and affiliates.
• Assist Regulatory Affairs in developing drug/device regulatory strategies and determining requirements for corrective actions or health authority reporting.
• Act as the medical contact for global health authorities on clinical/medical issues.
• Serve as company spokesperson for clinical research publications and presentations to health authorities and advisory committees.
• Explore and evaluate new product ideas to identify marketing opportunities.
• Support Clinical/Medical Affairs activities, including product evaluation, labeling, and surveillance.
• Support early clinical development for product potential and registration.
• Manage the budget for all project-related clinical activities.

Requirements

• MD (or equivalent) in a relevant area with appropriate post-doctoral training and certification.
• Minimum of 5 years of clinical research or pharmaceutical industry experience, including at least 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 experience.
• Expertise in clinical drug development, including demonstrated ability to develop clinical development plans meeting the highest standards.
• Global registration experience strongly preferred; experience working with Health Authorities is a plus.
• Experience working in a matrix environment.
• Ability to interface effectively with clinical operations, medical affairs, and marketing.

Skills

• Fluent in written and spoken English.
• Working knowledge of Microsoft Office suite (Excel, Word).
• Experience and knowledge of Good Clinical Practices and regulatory requirements for clinical trials and regulatory filings.

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 and date of hire, employees are eligible for the following benefits:

• Retirement & Savings: Participation in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Time Off:
  • Vacation: 120 hours per calendar year.
  • Sick time: 40 hours per calendar year (48 hours for Colorado residents; 56 hours for Washington residents).
  • 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, visit https://www.careers.jnj.com/employee-benefits.