Director, Clinical Project Scientist (Oncology)

At Johnson & Johnson,we believe health is everything.

Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions 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 a Director, Clinical Project Scientist located in Warsaw, Poland.

Remote based options within Poland may be considered on a case by case basis and if approved by the company.

A pre-identified candidate has been identified for the position, however all applications will be considered.

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 me...