Associate Director, Senior Clinical Scientist T6
4 weeks ago
- 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%).
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