Executive/Senior Executive - Costing and Proposal (Early Phase Quotes)

Role & responsibilities

1. Early Phase Clinical Study Quotations (Core Responsibility)

• Lead preparation and review of quotations for:
• Phase I clinical Studies
• Early Phase - BA/BE studies (primary focus)
• Analyze study protocols and finalize costing based on:
• Study design (SAD/MAD, fed/fasted, replicate design, etc.)
• Subject population and complexity
• Clinical unit and operational requirements
• Collaborate with Medical / Operation / Project Management / Cross-Functional Teams and BD teams to ensure scientifically and operationally aligned Quotes-proposals.

2. Proposal Preparation Across Services

• Prepare / review / Finalize quotations for:
• Pharmacovigilance (PV) Services
• Nutraceutical studies
• Clinical laboratory projects
• Biosimilars / large molecules studies
• Complex / adaptive Studies , Like Topical , Inhalation etc.
• Standalone CDM, Biostatistics & Medical Writing services
• Ensure consistency and integration across multi-service proposals.

3. Pricing Strategy & Business Development Support

• Provide pricing inputs based on study design, complexity, and resource planning.
• Support BD team in:
• Sponsor discussions
• Budget negotiations
• RFP responses and clarifications
• Ensure pricing competitiveness while maintaining profitability and compliance with company benchmarks.

4. Contract & Commercial Finalization

• Finalize quotations in line with approved protocols and sponsor expectations.
• Prepare and review:
• Project-specific agreements
• Work orders and commercial contracts
• Coordinate with Legal and Finance teams to ensure compliance and execution.

5. RFP, Bid Management & Commercial Documentation

• Lead preparation of:
• Bid grids , Inputs for RFPs & RFIs
• Cost models and summaries
• Annual Rate Contracts (ARC)
• Manage strategic and high-value RFP submissions in collaboration with BD leads.
• Take Management / Finance approvals as per process..

7. Cross-functional Stakeholder Coordination (Critical Responsibility)

• Coordinate with key internal teams for accurate costing inputs:
• Clinical Pharmacology / Early Phase Unit Team screening requirements, dosing, clinical procedures, unit utilization etc.
• Clinical Laboratory Team – PK/PD, safety lab and biomarker costing
• Regulatory Team –regulatory requirements
• Data Management (CDM) Team – EDC setup and data handling requirements
• Biostatistics & Medical Writing Teams – analysis and reporting
• Large Molecules / Biosimilars Team – specialized requirements
• Feasibility Team members / Clinical Operations Team – execution feasibility
• Drive timely inputs and alignment across all stakeholders.

8. Proposal Governance & Database Management

• Maintain a centralized master database of quotations, including:
• Version control
• Pricing benchmarks
• Historical proposals
• Track and report on:
• Turnaround time
• Orderbook
• Pricing trends
• Support management reporting and decision-making.