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Clinical Scientific Director

Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

The Clinical Scientific Director (CSD) is responsible for program level clinical activities including supporting the GPMD in developing the scientific and operational strategy of assigned clinical trials and programs; protocol development; and ensuring the collection, analysis, review, reporting and publishing of high quality trial data in compliance with Novartis processes, GCP/ICH and regulatory guidance. Program/project level responsibilities Develops scientific and operational plans for clinical deliverables, effectively applying principles of design excellence o Contribute to the development, writing and review of Clinical Development Plan (CDP) o Support the development and writing of the Operational CDP (O-CDP) in collaboration with key partner functions (e.g., GCO, IIS, etc) o Create trial concept sheet(s) o Develop other program level plans and support required internal Board approval o Develop and support implementation of program-level biomarker plans Drive the development, and support the approval, implementation and updates of disease standards within the CDU/TA; ensure their consistent application across all program/ trials; and define process, training, and tracking of standards. Support the Clinical Standards Steering Committee for cross Franchise development/implementation/training of clinical standards as required and participate as a subject matter expert in strategic initiatives as needed. Lead operational excellence in the CDU/TA and scientifically support CDU/TA to ensure development of program quality standards (e.g. collation of synopsis/protocols/CDP reviews, provide scientific/medical input, advisory boards, education activities). Develop strong scientific partnership with key investigators in assigned therapy area to optimize scientific quality/innovation of program and/or clinical study design, execution, reporting and publication. Assist Medical Lead with set-up of program and/or trial-related advisory groups. Support Novartis local medical organizations in the conduct of disease area training/regional advisory meetings. Collaborate with Medical Lead in the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators Brochures, briefing books, submission dossiers, and responses to Health Authorities questions, PSUR, DSUR, etc). Support trial outsourcing activities as needed in collaboration with relevant partner functions (e.g., DSS, GCO) Support Business Development and Licensing activities as needed from a functional perspective. Responsible for budget planning and management, and timely execution of assigned clinical deliverables within approved budget for the assigned section of the clinical program.Minimum requirementsAdvanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, PhD or MD strongly preferred. Fluent English (oral and written) 7 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization or Academia Manage several trials in parallel with multidisciplinary trial teams in a matrix organization Medical/scientific expertise appropriate to program Demonstrates ability to establish strong scientific partnership with key investigators Strong interpersonal skills Ability to work under pressure Excellent negotiation and conflict resolution skills Resolve issues with minimal supervision and understand when to escalate Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. Demonstrates excellent scientific writing skills Advanced knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data. Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
Degree: M.Pharm. (Pharmacy) | MD/ MS (Medicine) | Ph.D. (Doctorate)

Additional Degree: B.Sc. (Science)

Experience: 7-12


Clinical Research | Data Management/ Statistics
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