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82 Bristol-Myers Squibb Jobs

Associate Director, Senior Clinical Scientist

5-10 years

Hyderabad / Secunderabad

1 vacancy

Associate Director, Senior Clinical Scientist

Bristol-Myers Squibb

posted 8d ago

Job Description


  • 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%).

Employment Type: Full Time, Permanent

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What people at Bristol-Myers Squibb are saying

5.0
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Associate Director salary at Bristol-Myers Squibb

reported by 6 employees with 13-16 years exp.
₹55 L/yr - ₹75 L/yr
65% more than the average Associate Director Salary in India
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What Bristol-Myers Squibb employees are saying about work life

based on 133 employees
87%
80%
52%
90%
Flexible timing
Monday to Friday
No travel
Day Shift
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Bristol-Myers Squibb Benefits

Soft Skill Training
Cafeteria
Health Insurance
Team Outings
Job Training
Work From Home +6 more
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