| v AGM: Clinical Strategy: Medico Affairs. Client of First Resource |  | Experience : | 7 - 12 Years | | Location : | Mumbai | | Compensation : | Salary is no bar for the right candidate | | Education : | UG - MBBS - Medicine
PG - M.Pharma - Pharmacy,M.Sc - Any Specialization
| | Industry Type : | Pharma/ Biotech/Clinical Research | | Functional Area : | Healthcare, Medical, R&D | | Posted Date : | 01 Mar | |  | | Job Description Position : Clinical Strategy
Number of Positions: Three (3) (One for Oncology; One for Inflammation/Anti-infectives; One for Diabetes/Metabolic Disorders)
Position: Assistant General Manager
Department: Clinical
Group: Clinical Strategy
Reporting to: HOD
Education: MBBS with postgraduation in pharmacology or pharmaceutical sciences (M.S from US or Dip. Pharm Med. Royal college-UK) preferably course or diploma in clinical research
Experience: Experience of 7+ yrs in medical affairs of clinical research department with a leading CRO or research based pharmaceutical organization
Age Group: 30-38 years and flexible
Job description: - To lay down strategy for clinical development of compound and develop Concept Paper until finalization, for a therapeutic area
- To develop target product profile for compound
- Plan, overall manage all aspects of clinical study plan, end-points and conceptualize clinical study design, including adaptive designing
- To lay down strategic foundation for protocol, CRF and clinical study report preparation.
- Ability to identify expert panel for suggestions on clinical strategy
- Organize Investigator Meetings to finalize plan
- Identify and implement actions to keep projects on track e.g. interim analysis of reports, decide on ongoing project based on results available at hand,
- Critical evaluation of CRo’s and identify right CRO’s and/other vendor selection.
- Interface with project team members including: Drug ! Supply, Regulatory, Data Management, Statistics, Drug Safety , Finance Departments
- Ensures knowledge and implementation of new external or internal procedures
- Liasoning with Cross-functional teams like IND team, pre-clinical, formulations, toxicology, medicinal chemistry, pharmacology, Pk/Pd and others
- Handle presentations to regulatory authorities and lead scientific discussions ith various regulatory authorities including but not limiting to DCGI, US-FDA, MHRA, other EU authorities wherever required
Important Note We are not interested in Medico Marketing profiles. | | Desired Candidate Profile | | Company Profile Our client is one of the most reputed Biological science R&D and Drug development organizations of the world. | | |
Regards,
Naukri.com Team
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