US-IL, Clinical Research Medical Director, Immunology & Dermatology 210804BR-MZ
Clinical Research Medical Director, Immunology & Dermatology
US GEN MED
Research & Development
Immunology & Dermatology
Novartis is actively recruiting a Clinical Research Medical Director, Immunology & Dermatology - Home Based from the Midwest.
A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today -- a pipeline of innovative medicines brought to life by diverse, talented, performance driven people. All of this makes us one of the most rewarding employers in our field. We're committed to peak performance, improving the quality of life, and embracing and leveraging diverse backgrounds, cultures and talents to achieve competitive advantage.
The Clinical Research Medical Director, in US Clinical Development & Medical Affairs, will provide a high level of medical expertise to achieve Novartis objectives in the area of Clinical Drug Development in the Immunology & Dermatology area.
Primary medical responsibility for Development Clinical Trials this includes protocol feasibility, physician to physician contact, protocol training, medical issue/question management, safety review and local regulatory interaction. May be called upon to provide strategic medical input for a given therapeutic area into protocol design at a global level. Cooperates with US and Global Medical Affairs colleagues to identify/involve investigators and key opinion leaders in order to exploit the value of the assigned project(s) in the contest of the investigational product(s). Discussion with key opinion leaders regarding compounds in early development.
Provide medical expertise specific to US.
Lead and/or perform protocol, country and site feasibility.
Provide consolidated feasibility and site selection input to global and US teams.
Provide protocol, Risk management plan & disease training as appropriate at Investigator s Meetings or scientific venues or internally.
Perform local AE review and provide general medical support for safety issues:
Provide medical expertise support to pharmacovigilance activities.
Be aware of clinical trial SAEs on a country level.
Follow-up with the Investigator for additional information or clarifications as needed.
When necessary, provide medical expertise to Clinical Operations activities for safety amendments, INs, etc.
Review and try to resolve local medical issues / questions that arise during the entire course of the study
Assist in writing country or site specific Informed Consent Forms (ICF).
May be called upon to provide strategic medical input into protocol design at a global level.
Support Regulatory Affairs, Health Economics, Drug safety and epidemiology and Medical Information with medical input as appropriate as this relates to clinical trials.
Support ICRO/ and Global teams in interaction with regional regulatory agencies.
Provide assistance to ICRO and site for IEC/IRB Interactions.
Support planning, implementation and follow-up of regulatory agency inspections and internal audits.
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.
Position will be filled at level commensurate with experience.
MD preferred. Also open to a PharmD or DNP.
Experience in a pharmaceutical / medical practice and fully trained in all aspects of drug development including clinical research, GCP, local regulatory requirements and data privacy laws.
Subspecialty training in Immunology & Dermatology highly desired.
Details of Technical Competency:
Protocol Execution: Demonstrates knowledge of how to adequately review and read a protocol to understand specifics of study design and answer questions regarding the trial.
Applies a detailed understanding of the drug in question to provide medical context as it relates to disease processes, populations, and standards of care.
Ability to assess the feasibility of implementing the protocol based on regional medical practice.
Demonstrates a high level of understanding of the protocol to train others on the protocol including site personnel where applicable.
Demonstrates understanding of the protocol to evaluate investigator / site patient protocol compliance and patient safety.
Regulatory & Compliance: Demonstrating an understanding of regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
Applies knowledge of regulatory / industry rules to work in a local regulated environment.
Demonstrates current knowledge of relevant local regulations and compliance requirements and communicates to global teams as required.
Demonstrates knowledge of applicable SOPs, policies, procedures, and guidance documents.
Expertise to represent company as safety expert for clinical trials to external regulatory and compliance bodies such as regulatory agencies, boards of health, and ethics committees.
Safety Monitoring: Providing medical or scientific expertise to facilitate the safe use of product(s) in clinical trials.
Demonstrates knowledge of drugs and their safety profiles.
Applies safety expertise to answer local safety questions and provide required information to Headquarters where appropriate.
Applies medical expertise to provide prompt review and follow-up on all SAEs.
Ability to manage a study from the medical perspective, and a demonstrated capability to problem-solve and mediate complex medical / operational issues within the regional and therapeutic area context.
A minimum of two years pharmaceutical industry or clinical trial management experience required.
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