Job Description Summary
Location: Seoul, Korea #LI-HybridNovartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
This role is accountable for all country clinical or medical aspects associated with Development. Prioritized research programs or trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. This position may work across several countries.
Gathers, informs and acts on clinical, medical, scientific insights for clinical trial concept sheets or protocols. Drives the identification and involvement of qualified investigators with greatest recruitment potential, identifies clinical recruitment hurdles and drives clinical recruitment activities to overcome these hurdles.
This role also accountable for adherence to safety standards and clinical data quality in the country by providing general clinical or medical support for trial related safety findings. In close collaboration with other country functions and actively contribute to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays and development and implementation of mitigation plans.
Job Description
Key Responsibilities:
Provides Clinical Development and indication expertise specific to Country/Cluster, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines.
Validates study designs, is accountable for, and makes the final decision on the clinical or medical trial and program feasibility of implementing a clinical trial protocol based on medical/clinical practice and analysis of the competitive environment in the country.
Actively contributes to scientific,clinical or medical aspects of the start-up phase to ensure fast clinical trial site start-up. Provides clinical or medical expertise to relevant teams.
Decides on site Country-specific scientific,clinical or medical content of the Informed Consent Form (ICF) as needed and ensures appropriateness of patient suitable language.
Provides scientific, clinical or medical experts during interaction with relevant teams.
Develops clinical or medical trial plans by taking the broader ecosystem into account for assigned trials to ensure successful trial implementation. Leverages innovation in clinical trial planning and decides on clinical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
Work closely and support with internal stakeholders. Gathers, informs, and acts on insights from external parties with internal stakeholders with the goal to optimize clinical trial implementation. Supports planning, implementation, and follow-up of clinical components of Regulatory Authority inspections and internal audits.
Reviews and resolves Country trial-related clinical questions. Accountable for adherence to safety standards, clinical data quality. Supports the Global Clinical Development team as needed. May support innovative study designs by identifying and conducting quality assessments.
Drives all clinical ormedical activities in adherence to GCP (Good Clinical Practices), and in line with ICH (International Conference on Harmonization) and Country regulations. Provides scientific,clinical or medical input to the overall product strategy. Provides a superior customer experience for Investigators/site study teams.
Essential Requirements:
Medical Degree (MD,MBBS)
Ideally, 3 years of clinical development experience in the pharmaceutical industry or clinical practice.
Sound understanding of the overall clinical development process, and ICH/GCP principles.
Ability to manage a study from the scientific, medical or clinical perspective, and a demonstrated capability to solve problems and mediate complex issues.
Ability to lead effectively by communicating well, motivating a cross- functional team, and handling and delegating responsibilities. Agility to move quickly across different therapeutic areas and indications.
Demonstrated problem-solving skills and comfort with complexity. Ability to prepare and deliver high quality presentations
Commitment to Diversity and Inclusion / EEO paragraph
Novartis are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Skills Desired
Building Construction, Clinical Practices, Clinical Research, Clinical Trials, Drug Development, Hazard Identification, Health Sciences, Immunology, Intensive Care UnIT (Icu), Internal Control, Internal Medicine, Job Description, Medical Information, Organization Skills, Patient Care, Stakeholder Engagement, Tcp/Ip Protocols, Utilization Management (Um)