Associate Director, Senior Clinical Scientist

Position Summary: Leads the ECD Clinical Science team in the planning and execution of clinical trial activities to support the Clinical Development Plan for the disease/indication team Responsible for design and execution of assigned clinical trial activities and works closely with clinical team members to execute activities associated with trial conduct. May lead or support trial level activities for one or more trials with the necessary supervision. Duties / Responsibilities: Manages and supervises a team of Clinical Scientists in ECD to execute trial level activities for multiple trials Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members. Plan and lead the implementation of all study startup/conduct/close-out activities as applicable. Evaluate innovative trial designs (collaboration with Medical Monitor/Clinical Development Lead) Collaborate and liaise with external partners (e.g., KOLs). Provide regular and timely updates to manager/management as requested. Collaborate cross-functionally to develop Protocol and ICF documents / amendments and present these to governance committee and early clinical development team meetings as required. Collaborate cross-functionally to monitor clinical data for specific trends. Contribute to the development of Data Review Plan in collaboration with Data Management. Author/review clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., Pre-IND, IND, IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission) Reporting Relationship: Director, Clinical Science HOCT Qualifications Specific Knowledge, Skills, Abilities: Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred) 5 years of experience in clinical science, clinical research, or equivalent Experience in driving, managing and collaborating in a team/matrix work environment Recognized internally and externally as a Therapeutic Area and Functional expert Advanced knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations Ability to plan and manage Advanced ability to analyze, interpret, and present data Advanced knowledge and skills to support program specific data review, trend identification, data interpretation Advanced knowledge of indication, therapeutic area, compound(s), competitive landscape and health authority requirements Advanced medical writing and presentation skills Ability to self-supervise, and act independently to identify/resolve program level issues Proficient critical thinking, problem solving, decision making skills Effective planning and time management Advanced verbal, written and interpersonal skills (communication skills) Adaptable and analytical Strong presentation skills / leadership presence Commitment to Quality Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an 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), J-Review or similar data reporting tools Domestic and International travel may be required (10 - 25%). HYDDD HYBRID

Location: hyderabad, IN

Posted Date: 4/19/2025