Associate Director, Global Trial Lead at Bristol-Myers Squibb

Hyderabad, Telangana, India

Bristol-Myers Squibb Logo
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, BiotechnologyIndustries

Requirements

  • Expertise in strategic and operational oversight for global clinical trials
  • Ability to ensure trials are executed on time, within budget, and in compliance with regulatory standards and internal policies
  • Experience leading cross-functional alignment, issue and risk resolution, and study-level strategy
  • Proficiency in managing vendor relationships, performance, and quality
  • Capability to lead global initiatives and support Operational Portfolio Leads
  • Knowledge of therapeutic areas and global clinical operations trends
  • Mentoring and development skills for global GDO Study Team members

Responsibilities

  • Spearhead collaboration with internal study teams and vendors to meet timelines, budgets, and quality benchmarks
  • Provide strategic input on study feasibility and oversee operational activities of internal and external contributors
  • Identify and proactively manage risks, balancing trade-offs between cost, deliverables, and quality
  • Manage scope of work (SOW) for CROs and Vendor Partners, ensuring alignment with contractual terms, budgetary targets, and quality standards
  • Participate in vendor selection and evaluation processes
  • Review, approve, and reconcile vendor invoices, accruals, and scope amendments
  • Utilize performance metrics and quality indicators to monitor and optimize trial execution
  • Maintain and ensure accurate data records in study management systems such as Veeva (CTMS, eTMF, etc.)
  • Develop and enforce trial-specific standards aligned with broader portfolio strategies
  • Lead development and execution of cross-functional and global best practices
  • Establish and maintain study-level project management tools (action logs, decision trackers, issue registers, risk mitigation plans)
  • Collaborate cross-functionally for timely knowledge and information sharing
  • Offer therapeutic and operational guidance on study protocols and execution strategies
  • Provide consultation across programs/studies focused on risk mitigation and operational excellence
  • Monitor trends in clinical operations and advise on proactive responses
  • Mentor global GDO Study Team members within assigned therapeutic areas and others

Skills

clinical trials
strategic oversight
operational management
risk resolution
vendor management
regulatory compliance
cross-functional alignment
global development
study execution
portfolio management

Bristol-Myers Squibb

Develops and delivers biopharmaceutical medicines

About Bristol-Myers Squibb

Bristol Myers Squibb (BMS) develops and delivers medicines aimed at treating serious diseases, focusing on areas like cancer, autoimmune diseases, and heart conditions. The company conducts extensive research and development to create new drugs, which are sold after receiving regulatory approval. BMS also produces generic drugs, offering affordable alternatives that meet the same quality standards as their branded counterparts. What sets BMS apart from competitors is its dual focus on both innovative and generic medicines, enhancing access to healthcare. The company's goal is to improve patient outcomes while maintaining a commitment to sustainability and corporate responsibility.

New York City, New YorkHeadquarters
1887Year Founded
$33,706.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Benefits

Flexible Work Hours
Hybrid Work Options
Professional Development Budget

Risks

Increased competition in oncology from emerging biotech firms like ArsenalBio.
BMS's lawsuit over the 340B Drug Pricing Program may lead to regulatory challenges.
Rapid AI and digital tech evolution may pose integration challenges for BMS.

Differentiation

BMS focuses on innovative cancer treatments through collaborations like ArsenalBio for T cell therapies.
The company emphasizes digital health technologies, enhancing clinical trial management and patient engagement.
BMS offers both innovative and generic medicines, increasing affordable healthcare solutions.

Upsides

BMS's partnership with Medidata enhances clinical research processes and patient outcomes.
The collaboration with AI Proteins advances novel miniprotein-based therapeutics, expanding therapeutic modalities.
BMS's global license agreement with BioArctic expands its portfolio in neurodegenerative diseases.

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