Associate Director – Senior Clinical Scientist (Early Clinical Development)
Location: Hyderabad, Telangana, India
Experience Required: 10+ Years
Job Type: Full-Time
Job ID: R1596138
About Bristol Myers Squibb (BMS)
Bristol Myers Squibb (BMS) is a global biopharmaceutical leader dedicated to transforming patients’ lives through science™. Our work spans oncology, immunology, cardiovascular diseases, and other therapeutic areas, delivering life-changing medicines and innovative clinical solutions. BMS fosters a culture of collaboration, innovation, and inclusion, empowering employees to grow professionally while making a global healthcare impact.
Position Overview
The Associate Director, Senior Clinical Scientist will provide strategic clinical and medical leadership across early-phase clinical trials, including first-in-human (Phase I), proof-of-concept (Phase I/II), and clinical pharmacology studies. This role will serve as a primary source of medical accountability, guiding trial-level activities, mentoring clinical scientists, and ensuring data quality, regulatory compliance, and operational efficiency.
Key Responsibilities
Clinical Trial Leadership
Lead, plan, and execute multiple early-phase clinical trials with minimal supervision.
Provide oversight and medical accountability for trials from Phase I through proof-of-concept.
Design and develop clinical studies aligned with asset strategy, including biomarker qualification and dose selection.
Protocol & Regulatory Support
Manage Protocol and Informed Consent Form (ICF) development, including writing, review, and cross-functional adjudication.
Author and review clinical study reports (CSRs) and regulatory documents (pre-IND, IND, IB, DSUR, regulatory responses).
Serve as primary liaison for clinical and site-facing activities, including training and clinical query support.
Data Monitoring & Safety Oversight
Conduct and oversee clinical data review, CRF design, and query resolution to ensure quality and consistency.
Identify clinical data trends and escalate issues to study physicians or Medical Monitors.
Collaborate with Worldwide Patient Safety to assess key serious adverse events and contribute to safety narratives.
Scientific & Medical Leadership
Maintain deep expertise in assigned therapeutic area, including disease etiology, natural history, and treatment landscape.
Support early clinical development planning and provide scientific input for study design, benefit-risk analysis, and regulatory submissions.
Represent BMS in advisory boards, health authority interactions, and external scientific forums.
Cross-Functional Collaboration
Collaborate with Translational & Discovery Scientists, Clinical Development Teams, and cross-functional colleagues.
Contribute to protocol governance committee presentations and early clinical development team meetings.
Mentor and support junior Clinical Scientists, fostering a high-performing, compliant, and collaborative environment.
Required Qualifications & Skills
Education: MD or DM in Clinical Pharmacology or Oncology.
Experience: 10+ years in clinical research, early clinical development, or clinical science roles.
Clinical Expertise: Early Clinical Development medical monitoring experience strongly preferred.
Regulatory Knowledge: Advanced understanding of GCP, ICH, study design, statistics, and clinical operations.
Technical Skills: Proficient in Microsoft Office, EDC systems (e.g., RAVE), J-Review, and clinical reporting tools.
Leadership: Demonstrated ability to lead cross-functional teams and mentor junior staff.
Communication: Excellent verbal, written, and interpersonal skills; able to collaborate across organizational levels.
Travel: Domestic and international travel (10–25%) may be required.
Why Join BMS
Lead innovative early-phase clinical programs impacting global patient care.
Work in a collaborative, inclusive, and high-performing culture.
Access opportunities for professional growth, global exposure, and leadership development.
Contribute to transformational therapies across multiple therapeutic areas.
Equal Opportunity & Accessibility
BMS is committed to diversity, equity, and inclusion. Applicants with disabilities may request reasonable accommodations during the recruitment process. The application process is secure and transparent; BMS will never request payments or financial information.
Apply Now to be part of a team transforming patients’ lives through science.
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