QUALIFICATIONS:
• Experience in CR&D roles/responsibilities or equivalent
• Proficient knowledge of GCP/ICH, drug development process from discovery to registration,
study design, statistics, clinical operations
• Excellent verbal, written, communication and interpersonal skills. Must be able to effectively
communicate and collaborate across functions and job levels.
• Ability to assimilate technical information quickly
• Detail-oriented
• Basic leadership presence
• Strong sense of teamwork; ability to lead team activities
• Proficient knowledge and skills to support program specific data review, trend identification,
data interpretation
• Proficient in Medical Terminology and medical writing skills
• Proficient knowledge of the disease area(s), KOLs, indication(s), compound(s) under study
(including MOA, PK/PD, biomarker & safety profile)
• Knowledge of the establishment and operation of data monitoring committees, dose review
teams, and independent response adjudication committees.
• Proficient critical thinking, problem solving, decision making skills
• Understanding of functional and cross-functional relationships
• Commitment to Quality
• Adaptable / Flexible (willing and able to adjust to multiple demands and shifting priorities;
ability to meet day-to-day challenges with confidence and professionalism)
• Proficient planning/project management skills (ability to develop short to mid-range plans
that are realistic and effective in meeting goals
• Proficient in Microsoft Word, Excel, PowerPoint, Electronic Data Capture (e.g., RAVE), or
similar data reporting tools