Job Overview:This position reports to Director, Clinical Research Scientist and is part of Clinical Development, which designs and executes clinical programs to evaluate the safety, efficacy, and value of investigational therapies. This is an exciting opportunity to contribute to the development and execution of clinical research programs in oncology while building clinical development expertise. Through extensive interaction with the Clinical Research Team, this role will support the planning, conduct, analysis, and reporting of clinical studies in collaboration with crossfunctional teams including clinical operations, data management, statistics, programming, translational research, etc.
Essential Functions Required for Job
- Support the Clinical Research Team in the planning, execution, and monitoring of clinical studies.
- Assist with protocol compliance review, including assessment of inclusion and exclusion criteria, patient medical history, concomitant medications, and key safety and efficacy measures.
- Support review and documentation of protocol deviations in collaboration with the Clinical Research Team.
- Assist with ongoing review of subject-level clinical data and contribute to identification of data trends and potential issues.
- Collaborate with cross-functional team members to support review, analysis, and interpretation of clinical study results.
- Assist with the preparation of study-related documents including protocols, informed consent forms, clinical study reports, study presentations, and other clinical documents.
- Support database lock activities, data review efforts, and preparation of study deliverables.
- Assist in the preparation of scientific publications, abstracts, posters, and presentations.
- Support investigator meetings, advisory boards, and other scientific meetings through meeting preparation, material development, and documentation.
- Maintain awareness of developments in oncology, clinical research methodologies, and regulatory requirements.
- Conduct literature reviews and summarize scientific and clinical information relevant to study objectives and disease areas.
- Perform other duties as assigned.
Knowledge, Skills and Abilities (general & technical):
- Basic understanding of the clinical drug development process and clinical trial conduct.
- Interest in oncology drug development; prior oncology experience is preferred but not required.
- Foundational knowledge of GCP, clinical research regulations, and clinical study methodology.
- Ability to review and interpret clinical data with guidance from senior team members.
- Strong analytical, organizational, and problem-solving skills.
- Effective written and verbal communication skills.
- Proficiency with Microsoft Word, Excel, PowerPoint, and related software applications.
- Strong attention to detail and ability to maintain high-quality work.
- Ability to work collaboratively in a cross-functional team environment.
- Demonstrated ability to manage multiple assignments and prioritize effectively.
- Eagerness to learn and develop clinical research and scientific expertise.
- Flexibility and adaptability in a fast-paced environment.
Education & Experience Requirements:
- BS/MS/PhD in a related life science discipline preferred.
- 2+ years of relevant clinical research experience in pharmaceutical, biotechnology, CRO, academic, or healthcare settings with advanced degree or 3+ years of relevant clinical research experience in pharmaceutical, biotechnology, CRO, academic, or healthcare settings with Bachelor's Degree or equivalent years of work experience.
- Experience supporting clinical trials or clinical research activities preferred.
- Oncology or hematologic malignancy experience preferred.
Other Requirements (licenses, certifications, specialized training, and physical or mental abilities required):
Travel Requirements:Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.
Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
People ManagementThis is an individual contributor role and does not have direct reports or formal people-management responsibilities.
Travel Requirements:Primarily remote role with periodic on-site meetings in office. Must be able to travel domestically and internationally as needed.
Mental/Physical Requirements:Fast-paced environment handling multiple demands is involved. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
The base salary range for this role is
$118,100.00 - $147,600.00
Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential, in accordance with applicable law.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
