Johnson & Johnson Careers

Medical Director, Neuroscience Medical Affairs

Titusville, New Jersey
Clinical Research MD


Job Description

Requisition ID: 6928181108



At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  
 
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.  
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  
 
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.  
 
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

The Medical Director is responsible for the design, conduct, analysis and reporting of clinical trials and research related activities within US Medical Affairs Neuroscience. Responsibilities include partnership with clinical operations personnel and frequent interactions with internal and external business partners including regulatory, brand marketing, Real World Value & Evidence (RW V&E), Janssen Research & Development (JRD), Global Medical Affairs, epidemiology, clinical investigators and key external experts. The Director will have responsibility for various activities related to a pharmacologic molecule (molecule responsible physician) such as pharmacovigilance, medically important results assessments (MIRA) evaluations, promotional review committee assignment, label revisions, speaker and sales representative training, and other similar activities. The Director will support training to meet current and future business needs of the franchise, as well as contribute to creating a work environment that engenders the company's commitment to equal employment opportunity and the value of a diverse work force.
Provide oversight and direction as required for the design, conduct and analysis of clinical trials; Specific activities include study design, protocol development, fulfilling the role of medical monitor and ensuring study conduct is in compliance with GCPs and applicable SOPs, directing appropriate analyses and preparing final reports, and partnering with regulatory affairs as required for filing of FDA documents. Must demonstrate effectiveness and productivity working in cross-functional teams either as a matrix leader or contributor.

  • Provides clinical and scientific leadership through interaction with internal and external experts, partners with colleagues across Medical Affairs, RW V&E, JRD, Brand Marketing, Regulatory Affairs, Global Medical Affairs, New Business Development, J&J Corporate Communications, and J&J Legal; Frequently interact with field based Medical Affairs personnel, participates in promotional copy review and supports medical information services; Responsible for development and review of regulatory documents for FDA submission. The Director may be expected to provide a leadership role in safety monitoring activities.
  • Participates in the development of scientific strategy and communication plans; Reviews manuscripts for scientific accuracy and fair balance. Participates in the process of post-hoc exploratory analyses and communication of the results.  Participates in the decision to fund investigator initiated studies and provides clinical support as required. Responsible for managing CROs, external agencies and contract personnel as required.
  • Develop and fosters relationships with thought leaders, scientific societies and advocacy groups.  Remains current with and contributes to the scientific literature within field of focus.   
  • Contribute to L&A activities as called upon and identifies  new compound opportunities.  Participates in J&J initiatives relevant to therapeutic responsibilities.




Qualifications
  • A minimum of 10+ years professional experience obtained in clinical practice, industry or academia, with at least 3 of which must be in the pharmaceutical industry is required.
  •  Mental Health training &/or experience required. 
  • Demonstrated success leading a clinical/scientific cross functional team preferred.
  • Experience in relevant therapeutic area and related healthcare environment (e.g. neuroscience) required.
  • Experience in neuroscience medical affairs preferred.
  • Board certification and clinical experience preferred.
  • Publication planning and execution experience preferred.
  • KOL engagement experience preferred.

Primary Location
United States-New Jersey-Titusville-
Organization
Janssen Scientific Affairs, LLC (6120)
Job Function
Clinical Research MD
Requisition ID
6928181108