Associate Director, Senior Clinical Scientist

Location: Prakāshamnagar

Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more  .

Job Description

The Senior Clinical Scientist reports through the Clinical Science function which provides scientific expertise necessary to design and deliver clinical studies and programs.
Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial Lead for one or more trials.
Responsible for planning and leading the Local Health authority/ Subject Expert Committee interactions for assigned projects.
Successfully leads, plans, and executes trial-level activities for multiple trials with minimal to moderate level of supervision.
Provides scientific and clinical leadership to the team of supporting Clinical Scientists (matrix leadership).
Co-leads study team meetings in partnership with the GDO protocol manager; and collaborates with cross-functional study team members.
May support clinical development planning (collaboration with Clinical Development Lead/Clinical Trial Physician for provision and analysis of data to support future planning).

Duties/Responsibilities

Maintain a thorough understanding of assigned protocols and protocol requirements; educate supporting team members.
Plan and Lead interactions with local health authorities including presentation to Subject Expert Committees.
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).
Protocol and ICF development process with minimal guidance; including writing, reviewing, adjudication/resolution of cross-functional comments, and ensuring high clinical quality (collaboration with Medical Writing).
Site-facing activities such as training and serving as primary contact for clinical questions.
Activities related to data generation and validation, including CRF design, clinical data review/query resolution; ensure consistent, quality data review by supporting CS team.
Clinical data trend identification provide trends and escalate questions to the Medical Monitor
Develop a clinical narrative plan; review clinical narratives.
Provision of information required by the Protocol Manager for the development of the trial budget, CRO scope of work, etc.
Review development of site and CRA training materials and presentation at SIV and Investigator meetings and support on Study committee (e.g., DMC) activities.
Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, regulatory responses).
Collaborate and serve as the primary liaison between external partners for scientific advice.

Qualifications and Experience

Medical qualification (MD in Pharmacology, Oncology or Hematology is preferred)
10+ years of experience in clinical science, clinical research, or equivalent
Excellent track record of leading scientific interactions with DCGI and Subject Expert Committees
Experience in Oncology and Hematology therapeutic areas is preferred
Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
Proficient knowledge and skills to support program-specific data review, trend identification, and data interpretation.
Knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees.
Excellent verbal, written, communication, and interpersonal skills.
Strong sense of teamwork; ability to lead team activities.
Proficient knowledge of the disease area(s), KOLs, indication(s), and compound(s) under study (including MOA, PK/PD, biomarker & safety profile).
Proficient critical thinking, problem-solving, and decision-making skills.
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…