Advanced Clinical/Science Degree is required (e.g. MD, Pharm.D., Ph.D., MSN)
A minimum of 5 years experience in clinical science, clinical research, clinical development or equivalent in oncology
Proficient knowledge of oncology, analysis and interpretation of clinical data
Able to communicate (written and oral) clinical and scientific data to a broad range of audiences
Requirements:
Partner on study teams of internal experts to execute clinical studies
Collaborate with the Medical Director to build innovative clinical development plans
Develop and maintain clinical trial protocols and study reports
Review and validate clinical study reports and clinical portions of regulatory documents
Job description
Duration: 6 Months contract Location: REMOTE
Job Summary
The Scientific Director (SD) will provide scientific and clinical input to early and late-stage oncology clinical development programs with an emphasis on protocol-specific and medical data review activities. This includes collaborating on the design, implementation, and execution of study protocols. They will be responsible for the review of data from assigned clinical trials, as well as assist with data interpretation and communication to both internal and external stakeholders. The SD may also assist in health authority and ethics committee communications, as appropriate.
Primary Responsibilities:
Partner on study teams of internal experts (e.g. medical, safety, clinical operations, statistics, precision medicine, clinical pharmacology, regulatory) to execute clinical studies
Collaborate with the Medical Director to strategize and build innovative, robust clinical development plans and trial designs
Develop and maintain clinical trial protocols, related manuals/documents, and study reports
Review materials to support SIVs, Investigator Meetings, and Safety Review Committees
Review clinical database on a routine basis
Identify clinical trends in datasets and escalate as appropriate
Review and validate clinical study reports and clinical portions of other regulatory documents (e.g. IB, DSUR, responses to health authorities)
Provide scientific expertise and support for regulatory filings and interactions, including responses to health authorities
Author internal clinical documents, abstracts, posters, and presentations for scientific and clinical conferences
Provide asset development updates to management as appropriate
Qualifications:
Advanced Clinical/Science Degree is required (e.g. MD, Pharm.D., Ph.D., MSN)
A Master’s degree may be considered with supporting industry experience.
A minimum of 5 years experience in clinical science, clinical research, clinical development or equivalent in oncology
Proficient knowledge of oncology, analysis and interpretation of clinical data (safety and efficacy), GCP/ICH, study design, statistics, biomarkers, pharmacokinetics, clinical operations, and regulatory requirement for clinical studies
Able to communicate (written and oral) clinical and scientific data to a broad range of audiences
High level of organizational and project management skillsOperate with a high degree of autonomy and professionalism
1. About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com . 2. Equal Employment Opportunity (EEO) Statement:
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. 3. AI Statement:
By applying, you acknowledge that AI-assisted tools may be used during hiring.
