Clinical Scientist - Psychiatry (Sr Manager)

Bristol Myers Squibb; Hyderabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Bristol Myers Squibb is seeking a Clinical Scientist - Psychiatry to design and execute clinical trial activities and collaborate with cross-functional teams and external partners. This role may lead or support trial activities, develop protocols, ICFs, and contribute to regulatory submissions.

The position emphasizes deep knowledge of GCP/ICH, data review, and medical writing, with travel as required to manage trials and stakeholder meetings.

Qualifications

• Degree in Life Sciences or equivalent; advanced degrees preferred.
• 2+ years in clinical science, clinical research, or related field.
• Strong knowledge of GCP/ICH, drug development, study design, statistics, and clinical operations.

Responsibilities

• Design and execute assigned clinical trial activities within projects.
• Potentially lead one or more trials as Clinical Trial Lead.
• Develop Protocols and ICFs; present to governance and development teams.
• Collaborate with external partners (KOLs) and cross-functional teams.
• Monitor data trends and contribute to CSR and regulatory documents.

Skills

GCP/ICH knowledge

Clinical operations

Medical writing

Data review

MS Word/Excel/PowerPoint

Communication skills

Travel readiness

Education

Life Sciences degree

MD/PhD/PharmD/MS or related field

New entrants acceptable

Tools

Pt Profiles

CSR drafting tools

Job description

At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits. This is work that transforms the lives of patients, and the careers of those who do it.

The Clinical Scientist role is essential for providing scientific expertise to design and deliver clinical studies and programs. This position involves leading and executing clinical trial activities, collaborating with cross-functional teams, and liaising with external partners such as Key Opinion Leaders (KOLs). Key responsibilities include developing and presenting protocol documents, conducting literature reviews, monitoring clinical data, and contributing to clinical study reports and regulatory submissions.

Position Summary

• Will be responsible for design and execution of assigned clinical trial activities and work closely with clinical team members within the assigned project to execute activities associated with the conduct
• May serve as Clinical Trial Lead for one or more trials
• May lead or support trial level activities for one or more trials with the necessary supervision
• May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members

Position Responsibilities

• Collaborate and liaise with external partners (e.g., KOLs)
• Seek out and enact best practices with instruction
• Provide regular and timely updates to manager/management as requested
• Develop Protocol and ICF documents / amendments and present these to governance committee and development team meetings as required
• Conduct literature review
• Submit clinical documents to TMF
• Develop site and CRA training materials and present these at SIVs and Investigator meetings
• Review clinical narratives
• Monitor clinical data for specific trends
• Develop Data Review Plan in collaboration with Data Management
• Ensure CRF design adequately supports data collection in alignment with the protocol in collaboration with Data Management/Programming
• Submit clinical contributions to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, Orphan Annual Reports, HA, EC, IRB responses and contribute to regulatory submission.)

Education And Experience

• Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred). Appropriate for new entrance to pharma (post fellowship/ new to industry)
• 2+ years experience in clinical science, clinical research, or equivalent
• Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
• Ability to understand assigned protocol(s) and their requirements
• Basic knowledge skills to support program-specific data review and trend identification
• Intermediate medical writing skills and medical terminology
• Basic planning/project management skills (develop short range plans that are realistic and effective)
• Detail-oriented with commitment to quality
• Basic knowledge of disease area, compound, current clinical landscape
• Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
• Intermediate critical thinking and problem-solving skills
• Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
• Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
• Domestic and International travel may be required

We hire for skills and capabilities, not just credentials.

How We Work

Where you work matters – because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to [e-mail]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only: If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

If this posting is missing required information required by local law or incorrect, contact BMS at [e-mail] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607937 : Clinical Scientist - Psychiatry (Sr Manager)