Group head - Clinical Development Sciences
Global Drug Development
India Novartis Healthcare Private Limited
Research & Development
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The Group Head supervises Clinical scientific experts (CSE I/ CSE II) and facilitates their allocation across Development Programs/ Brands for planning and tracking all activities pertaining to one or more Development Programs/ Brands.
Responsible for allocating/ balancing resources under guidance from Head Clinical development sciences and based on the franchise/ portfolio needs.
Responsible for competency building of the team by coaching the Clinical Scientific Expert for ensuring the collection, review/reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements and program level activities as assigned.
Major Activities (Describe 8-12 main activities)
Accountable for overall management of Clinical scientific experts. Identify individual training needs to foster high levels of performance, support career development through quality development plans and proactively manage performance issues. Establish annual objectives according to priorities and individual development needs
Accountable for the hiring, on-boarding, training and mentoring of new staff.
Coach CSEs to:
- develop Reporting and Analysis Planning (RAP) modules in line with program standards
- perform blinded data reviews with specific focus on data integrity and efficiency and support GTL to prepare for database locks
- develop and implement relevant data capture tools as documented in (CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
- identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT).
Responsible to support development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks)
Input to process standards and tools to achieve excellence in CSE activities. Identify process improvements and best practices. In collaboration with the CSADs/ CSDs and key stakeholders, drive implementation globally in a manner that creates consistency, efficiency and with a high level of compliance across Franchises.
Perform skill-gap analysis and provide input/develop specific training programs in collaboration with training department to improve the capabilities of the staff.
Serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP.
Support Clinical development science activites as needed for process improvements and sharing best practices across programs.
Minimum requirements Education: Advanced degree in life sciences/healthcare (or clinically relevant degree) is required.
Master’s or PharmD.
PhD or MD strongly preferred.
Languages: Fluent English (oral and written)
Experience: • ≥3 years technical and operational experience in planning, executing, reporting and publishing clinical studies in industry or Academia
• > 5 years experience in team/ matrix management
• Medical/scientific expertise
• Prior experience of scientific partnership with 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