The Clinical Scientific Director (CSD) is responsible for leading clinical trial and/or program level scientific and clinical activities. The CSD leads the development of the scientific and operational strategy of assigned clinical trials and programs, is responsible for clinical trial protocol (CTP) development and implementation, and ensures the collection, analysis, review, reporting and publishing of high quality clinical trial data to support decision milestones, regulatory approval/market access, and budget targets for assigned trails and programs, in compliance with Novartis processes, adherence to NVS quality standards and GCP/ICH and regulatory guidance. The CSD co-leads the Clinical Trial Team (CTT) with the Global Trial Leader (GTL), may lead the Global Clinical Team (GCT), and may represent Clinical Development at the Global Program Team (GPT).
Develops scientific and operational plans for clinical deliverables, effectively applying principles of design excellence: -Contributes to the development, writing and review of Clinical Development Plan (CDP) - Supports the development and writing of the Operational CDP (O-CDP) in collaboration with key partner functions (e.g., COAR, DRA, DS&E, etc.) - Creates trial concept sheet(s), executable synopses and authors the final protocol -Develops other program level plans and support required internal Board approval -Develops and supports implementation of program-level biomarker plans. Leads the CTP development process by independently translating the CDP strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents supported by appropriate external (e.g., KoL, Regulatory Authorities, patients associations, etc.) and internal (e.g., TA , CPO Medical Advisors, review committees) medical/scientific input -Aligns input with other line functions -Develops and implements relevant data capture tools in collaboration with CSE, GTL, DM and CM as documented in data review plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks) -Co-authors Reporting and Analysis Planning (RAP) modules in line with program standards with Trial Statistician -Develops other trial related documents, such as data monitoring committee charter and organizes the review of the data by the committee -Drives science by incorporation of innovative designs and supporting biomarkers programs -Obtains approval from internal review boards - Ensures trial implementation according to protocol. Collaborates with Medical Lead in the development of clinical sections of program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities questions). In collaboration with Medical Lead and CSE, responsible for the ongoing review and quality of clinical trial data as outlined in the data review plan or equivalent, supports GTL in preparing data for database lock, performs data reconciliation, leads the final analysis and interpretation of results including the development of Clinical Study Reports (CSRs), publications, and internal/external presentations.
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, or PhD strongly preferred
7 years scientific, strategic, and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organization or Academia Advanced knowledge of the assigned therapeutic area is desired, with the capability to interpret, discuss and represent clinical trial or program level data
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively
Demonstrated ability to establish strong scientific partnership with key stakeholders
Thorough knowledge of GCP, clinical trial design, statistics, regulatory processes, and clinical development process
Managed several trials or led program sections in parallel with multidisciplinary trial teams in a matrix organization
Excellent communication skills, written and oral
Strong interpersonal skills
Excellent negotiation and conflict resolution skills
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