Associate Director Clinical Project Scientist (Immunology)
Janssen Research and Development, L.L.C., a member of
Johnson and Johnson's Family of Companies, is recruiting for an Associate
Director Clinical Project Scientist (Immunology) to be located in Spring House,
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.
& 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 Clinical Project Scientist 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
- 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, takes responsibility for coordinating completion of clinical
study reports, and supports preparation of relevant documents for regulatory
- 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.
- Integral in the collection and analysis of
clinical trial data, and assists with completion of clinical study reports
- Support the assessment and review of clinical
safety data from studies by collecting and summarizing appropriate safety
data/information for review by the Molecule Responsible Physician (MRP) and/or
Study Responsible Physicians (SRPs) or Safety Management Team (SMT).
- Assists in the evaluation of adverse events and
supports the interpretation and reporting of results. This will include
attending and presenting at 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 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 initiatives as
- Participate in Immunology TA initiatives as
- 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 5 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
- 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 10 % of time both domestic and
international may be required
& Johnson is an equal opportunity employer
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Research non-MDRequisition ID