Associate Director, Clinical Scientist

Role Summary

Location: Remote. The Associate Director, Clinical Scientist will report to the Executive Director, Clinical Science and be responsible for the execution of Clinical Development goals through collaboration with medical directors/physicians and Clinical Development department activities. The Clinical Scientist will represent the Clinical Science group on various teams and forums and is expected to perform responsibilities with a low to moderate level of supervision.

Responsibilities

• Review clinical data and ensure quality and consistency in clinical site reporting
• Develop and review Clinical Development documents including writing, reviewing, adjudication/resolution of cross-functional comments and ensuring a high-quality final document. Documents may include abstracts, manuscripts, clinical protocols/amendments, informed consent forms, regulatory documents, and other relevant materials.
• Develop and review presentations and training materials such as slide decks, posters, or other relevant materials
• Participate in the relevant Clinical Development Core Team and Clinical Sub-Team meetings as needed
• Interface with Biostatistics, Data Management, Clinical Operations, Project Management, Quality Assurance, Regulatory Affairs, and other members of the extended project team(s)
• Represent Clinical Science in operational meetings (e.g., Study Management Team meetings) as needed
• Maintain scientific and clinical knowledge in the relevant therapeutic and disease area(s)

Qualifications

• Preferred: Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD)
• 3 or more years clinical trial experience in pharma/biotech industry setting
• Preferred: Oncology research experience
• Data listing review experience is mandatory
• Experience authoring experimental protocols and/or study results and conclusions
• Strong understanding of Phase 1 through 4 drug development
• Excellent comprehension and analytical skills in interpreting scientific research and literature
• Sound knowledge of scientific and medical aspects of GCP, ICH, FDA, EMEA, NICE and other health authority guidelines and regulations
• Strong understanding of product and safety profiles
• Working knowledge of the multidisciplinary functions involved in a company’s drug development process, e.g. clinical operations, biostatistics, data management, regulatory, medical affairs
• Excellent time/project management skills with the ability to prioritize multiple tasks to meet short and long-term goals
• Strong oral and written communication skills, including interpersonal interactions, internal and site-directed communications and internal and external presentation skills
• Good judgment and decision-making skills