21 Sep
|
DigiCAD
|
Dholka
Job Description:
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).
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● 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.
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● 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).
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● Cross-Functional & Commercial Collaboration: Part
📌 President (Dholka)
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