About the Job:
The role is responsible for managing and executing techno-commercial negotiations for bioanalytical and clinical
studies , ensuring optimal commercial outcomes while maintaining scientific rigor, quality and regulatory compliance.The incumbent will support end to end study costing, proposal development, vendor negotiations and contract finaliztion in close collaboration with RND, Clinical, Quality, Legal, IT & Finance teams.
Job Responsibilities:
- Lead techno-commercial negotiations for bioanalytical, clinical and allied R & D studies with CRO's, laboratories and service providers.
- Prepare and review study cost estimates, budgets and commercial proposals ensuring accuracy,
- competitiveness and alignment with study scope.
- Evaluate RFP's/RFQ, assess feasibility and coordinate with internal scientific, clinical and IP/RA teams to finalize study requirements.
- Drive contract negotiations, including pricing, payment terms, timelines, change orders and amendments in collaboration with scientific/legal/Finance team.
- Manage vendor selection and onboarding in coordination with scientific team through capability assessments , compliance checks and commercial evaluations.
- Ensure adherence to regulatory and quality requirements in all outsourced studies
- Monitor study commercials and spend against approved budgets and highlight risks and deviations proactively.
- Build and maintain strong relationships with CROs and strategic partners to support long-term RND objectives.
- Support risk assessments and mitigation, including alternate vendor identification to ensure business continuity
- Prepare management reports and dashboards on negotiations status, vendor performance and cost optimization opportunities.
Educational Qualification:
- Postgraduate qualification in Pharmacy/Life Sciences/Biotechnology/Chemistry (MBA preferred)
Experience
- Min 10 years of experience in RND services, CRO operations, bioanalytical studies or techno-commercial roles within pharmaceutical organizations.
KEY RELATIONSHIPS/STAKEHOLDERS
External
- Contract Research Organizations (CROs)
- Bioanalytical and Clinical Laboraties
- Third party Analytical Laboraties
- Clinical trial service providers (PKPD/BA/BE, central Labs, sample logistics)
- Strategic RND service partners and consultants
- Auditors and Regulatory support vendors (as required)
Internal (other than Direct Reports)
- RND/Discovery & Development Teams
- Clinical Operations & Bioanalytical Sciences
- Quality Assurance and Regulatory Affairs
- Legal and Compliance
- IT Team
- Finance Team
- Project Management Teams
