Head-Clinical Development & SME
The company is looking for a multifaceted dynamic clinical research/development professional combined with prompt and astute decision-making capabilities and organisational skills. Extensive work experience of 22+ years in Clinical and Pharmaceutical domain, across Clinical Research Organisations & Global Pharmaceutical Company. Demonstrated and proven track record of managing entire Clinical development, Operations that include handling several complex global studies including BA/BE, Clinical End Point BE studies, Phase III trials, across various territories with huge cost savings.
- Demonstrated leadership ability of managing teams and coordination with cross-functional teams globally in the clinical development domain.
- Multi-tasking responsibilities also include selection of CROs across various geographies such as India, Mexico, South Africa, The Netherlands, Brazil, Indonesia, & Jordan, working on both technical and financial aspects including but not limited to, CDAs, MSAs, DPAs, Proposals, Cost Negotiations, Execution and delivery of projects.
- Organizing & Coordinating Investigational Medicinal Products including RLDs, procurement & supply from various global business units/ Third party Vendors to the respective CROs.
- Overseeing the regulatory document collection, review and submission process.
- Review and finalization of protocol, CRF, ICFs and other documents for consistency and to comply with respective regulatory requirements.
Job Location: South India
- Life Sciences
- Clinical Research (CRO)
- Job Level
- Senior Management
- ₹ 55,00,000 - ₹ 75,00,000
- 21 - 27 (in years)
- Reporting To
- Company Name
- Company Size