Medical Director, Clinical Development (Neuroscience)

6084-Janssen Research & Development, LLC Legal Entity; Titusville (NJ); On-site; USD 204,000 - 353,000; Full time

Benefits offered by this job

Pension plan

401(k) plan

Job summary

Johnson & Johnson is seeking a Medical Director, Clinical Development to support our Neuroscience therapeutic area. This role leads the medical integrity of psychiatry studies, reviews trial data, and contributes to study strategy and regulatory communications.

The position requires an MD degree, Neurology or Psychiatry board certification preferred, and at least 3 years of clinical/research experience in pharma or related settings. Travel up to 30% is expected.

Qualifications

• 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%.
• Proficient in communication and collaboration within cross-functional teams.

Responsibilities

• Provide cross-functional Clinical Development leadership for neuroscience studies and programs.
• Oversee study startup, maintenance and closeout to ensure data integrity and timelines.
• Act as primary medical contact for safety and regulatory communications.
• Develop relationships with sites and investigators; monitor trial conduct.
• Present regulatory and clinical development plans and results to senior management.

Skills

Travel flexibility

Teamwork

Communication skills

MS Office

Education

MD degree or international equivalent

Neurology or Psychiatry board certification preferred

Job description

Company Overview

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, and profoundly impact health for humanity. Learn more at jnj.com

Job Details

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 escalation 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.

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

Pay & Benefits

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

Equal Opportunity & Diversity

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.

Recruitment Process

Throughout the recruitment process - from application through hiring - we are committed to providing reasonable accommodations/adjustments for qualified candidates with disabilities. If you need support at any stage of the recruitment process, please complete our candidate accommodation request form so we can assist you.

Additional Information

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