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Job Title: Head – Clinical Research Company: Cadila Pharmaceuticals Ltd.

Location: Dholka, Gujarat, India Department: Clinical Development & Research Employment Type: Full-Time, Leadership Position Summary Cadila Pharmaceuticals Ltd. is seeking an accomplished executive leader to serve as Head – Clinical Research at our R&D; facility in Dholka, Gujarat. This role requires a high-caliber leader to oversee cross-functional operations including Bioavailability & Bioequivalence (BA/BE) studies, early to late-phase global clinical trials, Medical Affairs, Pharmacovigilance, Clinical Data Management, and Regulatory Compliance. The successful candidate will drive clinical development strategy, lead cross-site operational excellence, ensure compliance with international regulatory bodies, and manage multi- functional teams.

Key Responsibilities ● Strategic &

• Operational Leadership: Direct overall clinical research strategy, managing large-scale teams (250+ employees) across operational functions including Clinical Trial Operations, Medical Affairs, Pharmacovigilance, CDM, Biostatistics, and IT integration. ● ● Clinical Trial Execution: Oversee concurrent global/domestic clinical studies across complex therapeutic areas (e.g., biologics, oncology, metabolic disorders, ophthalmology, vaccines). ● ● BA/BE &

• CRO Management: Lead state-of-the-art clinical trial and BA/BE facilities, ensuring high margin efficiency, operational scaling, and cost-effective center execution.



● ● Regulatory Compliance &

• Inspections: Act as the primary technical authority for international regulatory audits and inspections, securing approvals from global agencies including USFDA, EMA, MHRA, ANVISA, DCGI, WHO, NPRA, and GCC. ● ● Safety &

• Systems Innovation: Implement automated IT platforms, centralized monitoring systems, site-reporting workflows, and specialized PV infrastructure (such as call centers/safety management platforms). ● ● Cross-Functional &

• Commercial Collaboration: Partner with R&D;, Regulatory Strategy, and Business Development to evaluate new molecules, support global marketing authorizations, and nurture relationships with Key Opinion Leaders (KOLs). ● Qualifications &

Experience ● Education: M.B.B.S. with M.D. in Pharmacology (preferred) or PhD/Post-Doc in relevant Life Sciences. ● ● Experience: 20–25+ years of senior executive experience in clinical research, pharmaceutical development, or CRO business leadership. ● ● Regulatory Track Record: Proven background in managing and successfully passing major global regulatory inspections (USFDA, EMA, MHRA, ANVISA, DCGI). ● ● Therapeutic Expertise: Exposure to biologics, monoclonal antibodies, biosimilars, small molecules, and multi-center trials. ● ● Leadership Capability: Robust track record in team retention, talent development, cost optimization, and multi-site organizational management.

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📍 Dholka