Director, Clinical Project Scientist

Janssen Research & Development, https://L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Director, Clinical Project Scientist located in Raritan, New Jersey or Spring House, Pennsylvania. Remote work options within the United States may be considered on a case-by-case basis and if approved by the company. 

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at https://www.janssen.com and follow us @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies.

The Director, Clinical Project Scientist (CPS) develops and leads goals/objectives and end to end delivery of clinical trials within the Oncology Therapeutic Area, including but not limited to designing, planning, developing, monitoring, and reporting of clinical research data. Interprets research results and evaluates the safety, marketability, and medical usefulness of drug product candidates. Responsible for the compliance of department, company and regulatory standards and procedures. This position may report to the CPS head or Clinical Leader.

Essential Functions:

• Executes clinical research strategies and contributes to the development and execution of clinical research programs

• Directs end to end delivery of clinical studies

• Defines clinical study parameters, supports deliverables, policy compliance and resource needs

• Serves as a clinical point of contact for cross functional teams and program level workstreams

• Reviews, evaluates, interprets results of clinical trial data preparation for submission and assists with interactions with regulatory health authorities

• Leads and performs medical monitoring/reporting, evaluates ongoing clinical trial data

• Manages and provides oversight on trial results

• Assists with development of clinical research protocols, study case report forms, informed consent forms

• Organizes documentation needed for data collection, analysis

• Reviews and maintains protocol specifications in alignment with standard operating procedures

• Guides and mentors less experienced team members in adherence to clinical research guidelines and safety procedures

• Maintains expertise on clinical trial documentation, requirements, regulations, operational procedures, study file requirements, regulatory requirements, policies

• Communicates detailed outcomes and results of research findings to relevant partners

• Anticipates areas of opportunity to ensure delivery of a quality database and contributes to data quality process improvements

• Presents research status at internal/external meetings, including investigator meetings and company sponsored events

• May lead one or more program or therapeutic area initiatives

• Works with high level of autonomy, providing decision accountability for project, owns escalations, and communicates effectively at all levels, including senior stakeholders

• Experience developing, presenting, and leading clinical data discussions

• Mentorship of less experienced team members and may have direct reporting/people management accountability

Principal Relationships

Contacts within the Company: 

·        Members of the Clinical and Cross Functional Trial teams

·        Members of Oncology TA

·        Cross Functional Senior Management

Contacts outside the Company: 

·        May act as a liaison, in partnership with Global Operations and Study Responsible Physician, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs

• Develops credible relationships with senior leaders, opinion leaders, medical directors, and key regulatory officials