Associate Director, Clinical Scientist

Role Summary

We are seeking an Associate Director, Clinical Scientist, who will report to the Executive Director, Clinical Science. You will be responsible for the execution of Clinical Development goals through collaboration with and support of Medical Directors/Physicians and Clinical Development department activities. The Clinical Scientist will represent the Clinical Science group on various teams/sub-teams or other appropriate forums and is expected to perform their 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

• Advanced Science/Clinical Degree is preferred (e.g., PhD, PharmD, MD)
• 3 or more years clinical trial experience in pharma/biotech industry setting
• Oncology research experience preferred
• 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 (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, NICE and other relevant 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, etc.
• Excellent time/project management skills: can prioritize multiple tasks to meet short and longer-term goals with high quality standards and in a timely manner
• 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