What are the responsibilities and job description for the Clinical Scientist - Oncology position at Planet Pharma?
Position Summary
Responsible for providing scientific support for Global Clinical Development activities. This includes assembling, evaluating, and presenting scientific and medical data, writing or providing content to clinical documents (clinical study protocols and protocol synopses, papers, abstracts, posters, etc.), and reviewing and summarizing relevant literature to inform strategic discussions.
The Clinical Scientist will collaborate with Clinical Operations, Translational Sciences, Clinical Pharmacology, Regulatory, Research and other functions within the company, as well as key partners external to the company. Working closely with colleagues in Clinical Development, the Clinical Scientist will have a substantial role in the development of the clinical documents, the review of scientific and clinical data, and the communication of data to the scientific and medical communities.
This position reports to the head of Clinical Sciences (Executive Director Clinical Scientist) and can be hybrid at our headquarters in New Haven, CT or work remotely from a location within the U.S.
Principal Responsibilities
Key responsibilities of this role include, but are not limited to:
Clinical Document Development
Lead the development of clinical study protocol synopses, full protocols and amendments, including engage with subject matter experts (internal and external) on study design elements and endpoints
Contribute to the clinical portion of investigator brochures, review IB for consistency and applicability
Contribute in the writing and review of clinical study reports (CSRs), data safety update reports (DSURs), annual reports and regulatory briefing books
Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
Participate in publication planning
Contribute to writing of departmental working processes (SOPs, templates, etc)
Clinical Study Planning
Assist clinical research physicians in developing clinical development plans
Contribute to the development of data collection tools, statistical analysis plans (SAPs), case report forms (CRFs)
Collaborate with cross-functional study team to assure timely study start-up including CRO selection, Data monitoring committee/Independent Radiology Reviewer activities, Central Lab on boarding etc.
Study Data Review and Analysis
Lead development of Medical Monitor Plans
Perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician
Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data management and other functional team members at assure quality and timely study conduct and monitoring
Provide support as needed for clinical and scientific issues that may arise during study execution
Work closely with biostatisticians and programmers to plan analyses of clinical data
Support data summaries for Cohort Review Committees, Safety Review Committees, leadership, advisory board meetings, etc.
Review of Scientific Literature
Experience in oncology therapeutic area required (depending on company needs), experience in hematology/Non-Hodgkins Lymphoma preferred.
Some basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations required
Excellent project management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross-functional teams
Passionate commitment and a strong team player
Ability to reliably deliver assigned objectives of high quality in a timely manner
Responsible for providing scientific support for Global Clinical Development activities. This includes assembling, evaluating, and presenting scientific and medical data, writing or providing content to clinical documents (clinical study protocols and protocol synopses, papers, abstracts, posters, etc.), and reviewing and summarizing relevant literature to inform strategic discussions.
The Clinical Scientist will collaborate with Clinical Operations, Translational Sciences, Clinical Pharmacology, Regulatory, Research and other functions within the company, as well as key partners external to the company. Working closely with colleagues in Clinical Development, the Clinical Scientist will have a substantial role in the development of the clinical documents, the review of scientific and clinical data, and the communication of data to the scientific and medical communities.
This position reports to the head of Clinical Sciences (Executive Director Clinical Scientist) and can be hybrid at our headquarters in New Haven, CT or work remotely from a location within the U.S.
Principal Responsibilities
Key responsibilities of this role include, but are not limited to:
Clinical Document Development
Lead the development of clinical study protocol synopses, full protocols and amendments, including engage with subject matter experts (internal and external) on study design elements and endpoints
Contribute to the clinical portion of investigator brochures, review IB for consistency and applicability
Contribute in the writing and review of clinical study reports (CSRs), data safety update reports (DSURs), annual reports and regulatory briefing books
Manage development of internal and external presentations/publications (manuscripts, posters, etc.) of clinical study data
Participate in publication planning
Contribute to writing of departmental working processes (SOPs, templates, etc)
Clinical Study Planning
Assist clinical research physicians in developing clinical development plans
Contribute to the development of data collection tools, statistical analysis plans (SAPs), case report forms (CRFs)
Collaborate with cross-functional study team to assure timely study start-up including CRO selection, Data monitoring committee/Independent Radiology Reviewer activities, Central Lab on boarding etc.
Study Data Review and Analysis
Lead development of Medical Monitor Plans
Perform ongoing clinical data review and critical analysis of study data including partnering with clinical research physician
Partner with Clinical Operations, Translational Medicine, Pharmacovigilance, Data management and other functional team members at assure quality and timely study conduct and monitoring
Provide support as needed for clinical and scientific issues that may arise during study execution
Work closely with biostatisticians and programmers to plan analyses of clinical data
Support data summaries for Cohort Review Committees, Safety Review Committees, leadership, advisory board meetings, etc.
Review of Scientific Literature
- Perform literature searches and critically review and summarize the relevant scientific, drug development and medical literature to support strategic discussions and document development, such as the investigator brochure, protocol design, clinical study report, competitive assessments, etc.
- Provide scientific/medical supportive materials to in-house staff and external consultants for the indications being studied
- Identify and review literature that addresses specific topics of interest relevant to drug candidates
Experience in oncology therapeutic area required (depending on company needs), experience in hematology/Non-Hodgkins Lymphoma preferred.
Some basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations required
Excellent project management, communication and organizational skills required with demonstrated success in leading projects and interacting with cross-functional teams
Passionate commitment and a strong team player
Ability to reliably deliver assigned objectives of high quality in a timely manner
- Competence in standard Microsoft applications
- Must be legally authorized to work in the US without the need for employer sponsorship now or at any time in the future.
- The duties of this role are generally conducted in a home (remote) or corporate office environment (hybrid). Employees must be able, with or without an accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
- A minimum of BS/MS with 10years relevant work experience within a research and/or pharmaceutical company environment required or demonstrated in-role capabilities if less than 10 years.