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.
Drive the development, and support the approval, implementation and updates of disease standards within the Therapeutic Area to 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 TA and scientifically support 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. Support trial outsourcing activities as needed in collaboration with relevant partner functions. 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.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
PharmD, PhD or MD strongly preferred.
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.
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