Senior Director, Clinical Lead - Neuropsychiatry

About the role

The Senior Director, Clinical Leader (CL) is responsible for the development and execution of medical and scientific strategies for late phase compounds (Ph2b/3). They lead the team in delivering these strategies through the effective leadership of a cross-functional Clinical Team (CT).

Responsibilities

• Develops and executes the clinical development plan and oversees the design of clinical trials.
• Oversees the content of clinical study reports.
• Manages the budget for all project-related clinical activities.
• Interprets, reports, and prepares results of product research for global health authority submissions and external communication.
• Evaluates adverse events (pre and post-marketing) for relationship to treatment.
• Manages the Independent Data Monitoring Committee (IDMC) and adjudication meetings as needed.
• Assists Regulatory Affairs in the development of drug/device regulatory strategies and determines requirements for any corrective actions or health authority reporting.
• Acts as the medical contact at the company for global health authorities concerning clinical/medical issues.
• Aids in exploring and evaluating new product ideas to assist in identifying new marketing opportunities.
• Supports general Clinical/Medical Affairs activities involving product evaluation, labeling, and surveillance.
• Manages early clinical development involving product potential and development for registration.
• Supports the evaluation of scientific opportunities in the therapeutic area.

Requirements

• MD (or equivalent) in relevant area with appropriate post-doctoral training and certification.
• Minimum of 5 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.

Qualifications

• Fluent in written and spoken English.
• Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings.
• Experience working in a Matrix environment is required.
• Ability to interface effectively with clinical operations, medical affairs, and marketing is essential.

Skills

• Clinical Development, Neuropsychiatry, Neuroscience.
• Clinical Research and Regulations, Clinical Trials, Collaborating, 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.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are 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. 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)). This position is eligible to participate in the Company’s long-term incentive program. 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 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 Condolence Leave – 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave – 10 days Volunteer Leave – 4 days Military Spouse Time-Off – 80 hours Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits