Director, Clinical Project Scientist (Oncology)
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 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 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 officialsEstimated Salary: $20 to $28 per hour based on qualifications.
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 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 officialsEstimated Salary: $20 to $28 per hour based on qualifications.
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