Janssen Research and Development, L.L.C., a member of
Johnson and Johnson's Family of Companies, is recruiting for an Associate
Director Clinical Research (Neuroscience) located preferably in Spring House,
PA, Raritan, NJ, Titusville, NJ , La Jolla, CA and Belgium (Beerse).
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. We pursue the most promising science, wherever it
might be found.
We discover and develop innovative medical solutions to
address unmet medical needs in oncology, immunology, neuroscience, infectious
diseases and vaccines, and cardiovascular and metabolic diseases. Visit
http://www.JanssenRnD.com to learn more.
- The Associate Director is a responsible member
of a clinical team dedicated to the development and execution of clinical
trials and the clinical and operational implementation of a complex compound program.
- The Clinical Scientist provides active
scientific contribution to a cross-functional clinical team developing a
molecular entity. Specifically, the Clinical Scientist provides input to the
clinical development plan, develops the clinical trial protocol and clinical
trial materials, engages in ongoing monitoring of study conduct, review and
analysis of clinical trial data, takes responsibility for coordinating
completion of clinical study reports, and supports preparation of relevant
documents for regulatory filings.
- This role involves extensive team matrix
interactions with a number of different disciplines.
- The position will also have responsibility for
various activities associated with safety monitoring and assessment of relevant
clinical studies/programs, and will have clinical ownership of or provide
clinical support for various regulatory documents, including the Investigator
Brochure, the Risk Template of the Informed Consent form, the Development
Safety Update Report (DSUR), the Periodic Benefit Risk Evaluation Report
(PBRER) and the Safety Risk Management Plan.
- The Clinical Scientist may be asked to
contribute to due diligence efforts in the therapeutic area.
- Supports preparation of clinical development
plans, trial protocols, and supports the Global Clinical Development Operations
group with trial set up, conduct, and monitoring, and database locks.
- Support the assessment and review of clinical
safety data from studies by collecting and summarizing appropriate safety
data/information including evaluation of adverse events for review by the
Molecule Responsible Physician (MRP) and/or Study Responsible Physicians (SRPs)
or Safety Management Team (SMT).
- Assists Regulatory Affairs in determining
requirements for any corrective actions or health authority reporting
- Interprets, reports and prepares oral and
written results of product research, in concert with senior clinical personnel,
in preparation for internal reviews and health authority submissions
- Responsible for data review in conjunction with
other clinical team members prior to database locks
- May be asked to participate in safety event
- Participate in cross-Pharma and Neuroscience TA
initiatives as requested
- Participate on and may lead cross-functional
teams for evaluation of new product ideas
- Reviews medical literature and related new
- A minimum of a Bachelor's degree is required
- Advanced degree (MD, MS, RN, RD, PhD or PharmD)
- A minimum of at least 3 years of clinical
research and development experience within the Pharmaceutical, Medical Device
OR CRO industry or experience as clinical research coordinator in non-industry
setting is required.
- Clinical research operational knowledge, strong
project planning/management and excellent communication skills is required
- Ability to operate with limited day to day
supervision is required
- Experience in Neuroscience Therapeutic Area is
- Independent decision-making and analytical
skills are required.
- Successful work experience in a matrix team
environment with cross functional teams is required.
- Travel up to 20% of time both domestic and
international is required
Johnson & Johnson is an equal opportunity employer
United States-New Jersey-TitusvilleOther Locations
North America-United States-Pennsylvania-Spring House, North America-United States-California-La Jolla, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID