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
