Associate Director, Clinical Project Scientist (1 Of 2)

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 https://www.jnj.com/ .

We are currently seeking an Associate Director, Clinical Project Scientist (Oncology). This position is based out of Spring House, PA or Raritan, NJ. Remote locations within the USA may be considered on a case by case basis and if approved by the company.

The Clinical Project Scientist (CPS) works in the Oncology Therapeutic Area Development group and will actively participate and may lead aspects of the development, oversight, and execution of Ph I-IV clinical research trials working closely with Study Responsible Physicians, Clinical Leaders, and other Clinical Project Scientists. The position reports to a more senior Clinical Project Scientist.

Essential Functions:

• In collaboration with the Study Responsible Physician and Clinical Leader, will actively participate in or lead aspects of, medical review of clinical trial data, including adverse events, efficacy data, patient screening/eligibility evaluation, PK/PD data, coding, and other data critical to study endpoints

• Participate or may lead drafting protocol synopsis, sections of full protocols, informed consent documents, review, and development of Case Report Forms (eCRFs), and other data collection tools against draft protocols and central vendor scope of work

• Participates in the start-up and day to day management of one or more global clinical studies, in compliance with department safety practices, policies, and procedures

• Partner or lead Cross Functional Trial Team to mitigate issues in initiation and management of one or more clinical trials and participate in review of Monitoring Guidelines, SET/IDMC charter, Statistical Analysis Plan, Data Management, and Safety Management Plans

• Performs medical monitoring/reporting, evaluates ongoing clinical trial data

• Liaise with external vendor laboratories and clinical research organizations to develop charters where applicable and ensure the collection and quality of data critical to study endpoints

• Liaise with Translational Research (pharmacokinetic operations & biomarker operations) to ensure robust sample collection, processing, and tracking

• Participate in the creation and maintenance of a robust Medical Review plan, medical review forms, and liaise with Integrated Data Analysis & Reporting in set-up, implementation, and maintenance of data visualization tools/medical review interface

• Participate in or lead aspects of training the central study team, local study team, site personnel or external vendors on protocol, disease evaluation criteria, or other specific aspects of the clinical study

• Participate and lead aspects of data review and drafting documents for submission to Health Authorities

• Actively participate in mentorship and training opportunities to expand clinical development knowledge, therapeutic area expertise, and leadership capabilities

Principal Relationships:

Contacts within the Company:

• Members of the Clinical and Cross Functional Trial teams

• Members of Oncology TA

Contacts outside the Company:

• May act as a liaison, in partnership with other Clinical Project Scientist(s), Study Responsible Physician(s) and Global Operations, between company and Investigators, Site Managers, Site staff, global clinical research staff, vendor project managers, and CROs