Career as Clinical Scientific Director in Novartis

Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.

Post : Clinical Scientific Director

Job Description
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 Clincal 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 organises 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 Timely input on the delivery and submission of high quality CTPs and other clinical deliverables (e.g., Final Protocol Package) aligned with CDP and TPP and endorsed by review committees and Franchise boards with acceptance by key external and internal stakeholders, including relevant Regions and CPOs; as well as O-CDPs and clinical component of regulatory documents
Applies effective clinical research methodology, including trail design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases
Strong evidence of efficient and timely execution of CTP and related documents in collaboration with GTL, in compliance with international and local regulations and Novartis internal standards; effective budget management including CSD Page 3 of 4 accurate and transparent forecasting and active management of issues that arise during the trial
Demonstrates advanced knowledge and application of statistical analysis methodology and can identify trends to effectively interpret / report data, and successfully completes data cleaning and review process within the required timelines across the trial with 100% clean data and no unplanned database unlocks that meet NVS Quality standards, reviews and audits
Demonstrated ability to deputize for GPMD or MD at GCT, as well as other venues as needed Demonstrates excellent scientific writing skills to enable the development of quality CDPs, CTPs, trial reporting, and regulatory documents
Clearly demonstrates Novartis Values and Behaviors
• High quality, timely clinical data review and document preparation meeting NVS quality standards, reviews and audit.

Candidate Profile :
Advanced degree in life sciences/healthcare (or clinically relevant degree) is required. PharmD, or PhD strongly preferred Fluent oral and written English ≥ 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

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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 CSD matrix organization
Excellent communication skills, written and oral
Strong interpersonal skills
Excellent negotiation and conflict resolution skills
Resolves issues wiwith minimal

Additional Information:
Experience : 7 year
Qualification : degree in life sciences
Location : Hyderabad
Industry Type : Pharma / Biotech / Clinical Research
Functional Area : R&D
Last date : 15th December, 2016