Associate Director, Senior Clinical Scientist

Lifelancer; Hyderabad; On-site; INR 2,500,000 - 4,000,000; Full time

Benefits offered by this job

Competitive benefits

Work-life balance programs

Opportunities for growth

Job summary

A leading biotech firm in Hyderabad is seeking an experienced Associate Director, Senior Clinical Scientist. In this role, you'll lead clinical trial activities and provide scientific leadership. Candidates should have an MD with over 10 years of clinical research experience, particularly in oncology. You'll collaborate with multiple teams and health authorities to ensure project success. This position offers an opportunity to make a significant impact in patient care through innovative clinical solutions.

Qualifications

• 10+ years of experience in clinical science or research.
• Excellent track record with DCGI and committees.
• Adaptable to multiple demands and shifting priorities.

Responsibilities

• Design and deliver clinical studies and programs.
• Lead clinical trial activities and health authority interactions.
• Ensure high clinical quality and collaborate across teams.

Skills

Clinical research

Scientific communication

Team leadership

Problem-solving

Project management

Education

MD in Pharmacology, Oncology, or Hematology

Tools

Microsoft Word

Electronic Data Capture

Job description

Job Title: Associate Director, Senior Clinical Scientist

Job Location: Hyderabad, Telangana, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Director

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: careers.bms.com/working-with-us.

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 elevate 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 reporting tools.
• Domestic and International travel may be required.

Uniquely Interesting Work, Life-changing Careers

With a single vision as inspiring as Transforming patients' lives through science™, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

On-site Protocol

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

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 Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

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/

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.

R1598023 : Associate Director, Senior Clinical Scientist