Head -Clinical Research

Inductive Quotient Analytics; Secunderabad, Hyderabad; On-site; INR 25,00,000 - 35,00,000; Full time

Job summary

A clinical research organization is seeking a Head of Clinical Trials & Medical Strategy in Secunderabad, India. This senior role involves driving clinical strategy, leading clinical operations, and collaborating closely with clients. Candidates should have 5+ years in clinical trials, strong proposal writing skills, and experience in regulatory discussions. The ideal candidate will possess an MBBS or MD and a proven ability to mentor teams and ensure compliance with quality standards.

Qualifications

• 5+ years experience in clinical research or trials, preferably in a CRO or Sponsor environment.
• Proven experience leading proposals and sponsor presentations.
• Familiarity with technology-enabled delivery models.

Responsibilities

• Oversee clinical delivery and execution for studies.
• Collaborate with cross-functional teams to ensure smooth delivery.
• Support sponsor engagements and help establish clinical operations SOPs.

Skills

Clinical trial lifecycle

ICH-GCP

Communication skills

Proposal writing

Stakeholder management

Education

MBBS, MD or equivalent postgraduate qualification

Tools

Clinical Trial Management Systems (CTMS)

Electronic Data Capture (EDC)

Analytics dashboards

Job description

Job Title: Head of Clinical Trials & Medical Strategy

Position Summary: Looking for a senior Physician leader to drive clinical strategy, sponsor-facing pre-sales, proposal development, and clinical operations leadership. This role will serve as a key face of IQA in client presentations, bid defenses, regulatory/scientific discussions, and will help build scalable clinical operations capabilities across trials.

Key Responsibilities

• Clinical Leadership & Trial Delivery Oversight (End-to-End)
• Provide clinical oversight for studies from start-up through close-out, ensuring fit-for-purpose execution and medical/scientific rigor.
• Define and review key delivery plans: Study Execution Plan, Monitoring Plan, RBQM/RBM approach, vendor oversight strategy, risk log.
• Act as escalation point for clinical questions: eligibility, endpoint interpretation, protocol deviations, site challenges, and quality risks.
• Collaborate with Clinical Operations, Data Management, Biostatistics, Medical Writing, and Product teams to ensure smooth delivery.
• Regulatory & Scientific Representation
• Support sponsor engagements for health authority interactions / scientific advice / pre-sub meetings (as applicable).
• Provide clinical input and review for essential documents: protocol sections, ICF key risks, safety narrative, clinical rationale, endpoint strategy.
• Ensure scientific consistency and alignment between protocol intent, operational feasibility, and data collection strategy.
• Sponsor-facing Pre-sales & Business Support
• Translate sponsor needs into fit-for-purpose trial delivery strategies (countries/sites, feasibility approach, endpoints practicality, patient recruitment considerations).
• Lead and contribute to RFP/RFI responses, proposals, capability decks, and bid defenses with strong clinical and operational narratives.
• Partner with Business Development to shape solution positioning, differentiators, and assumptions for timelines/costing (with Ops/Finance inputs).
• Present IQA’s end-to-end capabilities, including technology enablement (EDC, analytics, AI/automation), without compromising GxP compliance.
• Quality, Compliance & Inspection Readiness
• Ensure trial conduct aligns with ICH-GCP, local regulations, sponsor SOPs (where applicable), and IQA quality standards.
• Support audit/inspection readiness, CAPA review, and continuous improvement activities.
• Help establish and improve clinical operations SOPs, templates, and training materials.
• Capability Building & Leadership
• Build/mentor a high-performing Clinical Operations team (e.g., CTMs, CRAs, Project Managers, Site Management, Vendor Oversight).
• Create scalable playbooks and templates: feasibility checklist, start-up workflow, monitoring strategy, issue escalation, close-out checklists.
• Drive cross-functional alignment to deliver “service + software” execution models.

Required Qualifications

• MBBS, MD or equivalent postgraduate qualification is preferred.
• 5 + years’ experience in clinical research/clinical trials (CRO or Sponsor environment preferred).
• Proven experience contributing to or leading proposals, bid defenses, and sponsor presentations.

Strong Working Knowledge Of

• Clinical trial lifecycle (start-up, conduct, close-out)
• ICH-GCP, informed consent, essential documents, TMF expectations
• Safety reporting fundamentals and clinical oversight expectations
• RBQM/RBM concepts and operational risk management
• Excellent communication skills: able to present to senior sponsor stakeholders with confidence and clarity.
• Experience across multiple regions (India + US/EU/Japan exposure is a plus).
• Therapeutic depth in one or more areas (e.g., oncology, ophthalmology, CNS, cardiometabolic, devices).
• Experience building or scaling clinical operations teams/processes.
• Familiarity with technology-enabled delivery models (EDC, eCOA, eConsent, CTMS, analytics dashboards).

Key Skills & Competencies

• Sponsor-facing leadership and executive presence
• Strong clinical reasoning + operational pragmatism
• Proposal writing and structured thinking
• Stakeholder management and cross-functional collaboration
• Quality mindset, compliance orientation, inspection readiness
• Ability to build teams, systems, templates, and repeatable processes

Skills: clinical trails,leadership,readiness,clinical operations