Director, Clinical Science

RESPONSIBILITIES:

• Contributes to the clinical development strategy and operational plans working as part of an integrated drug development team
• Contributes to the development of the clinical study design and writing of the study synopsis and protocol
• Contributes to clinical development plans, clinical sections and review of other study related documentation (Investigator’s Brochure, Scientific Rationales/Justification, Regulatory agency briefing documents and responses to questions, Clinical Study Reports)
• Works with clinical sites to answer protocol related questions, resolve study conduct and design issues
• Contributes to the development of and participates in Investigator Meetings, Study Initiation Visits, and Advisory Boards as appropriate
• Reviews data listings, laboratory data, and vital signs data to establish the presence or absence of abnormal trends, and follows up as appropriate
• Involved in analysis of data for regulatory submissions, presentations, publications, and study designs
• Assists in review of all adverse experience reports for accuracy and clinical importance, characterization of severity, seriousness, and relationship to the study drug
• Works closely with other functions such as safety, biostatistics, data management, and regulatory affairs to provide accurate reports to FDA or other regulatory agencies
• Presents findings internally and externally (such as investigator meetings), acting as a spokesperson for the company relating to the trial/indication
• Attends scientific meetings to stay current on new developments within relevant areas
• Other duties as assigned

EDUCATION AND EXPERIENCE: 

• At least 2 years of oncology drug development experience
• Advanced degree in biological sciences or health-related field is required (e.g. Ph.D., Pharm. D, M.S.N, M.P.H., PA, NP)
• Experience operating independently implementing clinical trials
• Collaborative team player with excellent interpersonal and communication skills
• Ability to strategically and proactively think and lead in interdisciplinary teams
• Experience in data analysis and interpretation
• Experience in immuno-oncology preferred