We are currently searching for a skilled professional to join a well-known client’s team as a Remote Director, Clinical Scientist. The Director, Clinical Scientist will assist with the design and execution of clinical development plans for clinical studies. The ideal candidate will have a strong scientific and clinical research background and be able to assume a lead role in the planning and conducting the clinical trial. They will work within a multi-disciplinary, matrix team ensuring that clinical, scientific, and regulatory issues are appropriately considered with respect to highly complex clinical studies. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

• Develops scientific understanding of assigned program and protocol requirements
• Supports protocol design and development strategy for clinical trials
• Manages protocol development process; including writing support, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document
• Contributes to the development of Informed Consent Forms (ICF); reviews/supports finalization of regional and site ICFs as needed; ensure high quality, appropriate reading level text, and alignment with protocol
• Authors and reviews study materials for clinical trial utilization and health authority submissions
• Supports study start-up/conduct/close-out activities as applicable in collaboration with clinical operations and CRO
• Supports country/site selection activities and CRA training
• Liaises with site staff personnel, as necessary.
• Develops charter for study committee(s) (e.g., DMC, SRC) and plans meetings and presentation preparation
• Contributes to activities related to data generation and validation, including CRF creation, clinical data review, communication as needed to resolve data queries, draft/update/review data review plans
• Supports Medical Monitor in data review analysis and interpretation of patient and study level data
• Collaborates with translational medicine and bioanalytical team to analyze and assess biomarker data.
• Scientific author / contributor to internal and external communications, such as protocol training, posters, publications, and advisory board meeting presentations
• Maintains knowledge of the therapeutic area, current medical practice, and pharmaceutical regulations to help ensure best practices
• Collaborates with study team members (including Clinical Operations, Drug Safety, Regulatory Affairs, Precision Medicine, Project Management) to ensure that key milestones are met on time and with high quality

REQUIRED EDUCATION AND EXPERIENCE

Bachelor’s Degree in Scientific/Life – Science field. PharmD or Ph.D. preferred.

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.