Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - MD
Job Category:People Leader
All Job Posting Locations:Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America
Job Description:Johnson & Johnson is seeking a
Medical Director, Clinical Development, to support our Neuroscience therapeutic area.
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.
Learn more at https://www.jnj.com/innovative-medicine
The Medical Director, Clinical Development, will be responsible for the leadership, oversight, and medical integrity of psychiatry studies/programs. This individual will monitor clinical studies, review and interpret clinical trial data, provide input into clinical study and regulatory communications and reports, and contribute to clinical development plans and strategy.
Job Responsibilities:- Provide cross functional Clinical Development leadership for internal and external team members in the delivery of clinical studies:
- Provide a role in the strategic planning of clinical studies and programs, including the development of study design, milestones, key deliverables.
- Provide support and oversight to all other functional areas of the study teams throughout the lifecycle of the study (startup, maintenance, closeout) in order to ensure data integrity, resolve and/or escalate issues, achieve alignment, and adhere to study goals and timelines.
- Act as primary contact for medical communication to ensure medical safety within studies. Develop and maintain relationships with sites and Investigators.
- Provide medical monitoring, which includes reviewing study participant eligibility, protocol interpretation, coding support, protocol deviation review, and data cleaning in collaboration with Clinical Operations and Data Management.
- Work with Biometrics to contribute to the analysis and interpretation of clinical results.
- Author, review, and/or provide strategic input into:Clinical sections of regulatory documents including, IND submissions, annual updates, DSUR, investigator brochures, and briefing documents.
- Study specific documents such as study protocols/amendments, informed consent documents, case report forms, placebo justifications, and clinical study reports.
- Scientific publications, manuscripts, posters, or other documents intended for external audiences.
- Represent Clinical Development at Regulatory Authority Meetings.
- Present the clinical development aspects of a project and clinical trial results at internal or external meetings.
- Communicate to Senior Management and relevant functions any potential issues, risks or changes to the Clinical Development Plan.
- Complete all company and job-related training as assigned within the required timelines.
- Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
- Duties, responsibilities, and activities may change at any time with or without notice.
Job Requirements:- MD degree or international equivalent; active medical license preferred
- Specialty training or board certification in Neurology or Psychiatry preferred
- Minimum 3 years clinical/research experience in the pharmaceutical industry, relevant governmental organizations, or academic research setting required.
- Ability to travel at least 30%
- Ability to work in a team setting as well as function as an individual contributor
- Ability to work efficiently and under tight timelines
- Ability to communicate effectively
- Ability to be flexible in an ever-changing environment
- Ability to think strategically and be able to anticipate problems before they occur
- Ability to be proactive in finding solutions to issues
- Proficient in Microsoft Office (Word, Excel, PowerPoint)
- Must be able to perform all essential functions of the position, with or without reasonable accommodation
#LI-Hybrid
Required Skills:Preferred Skills:The anticipated base pay range for this position is :$204,000.00 - $353,050.00
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
