Job Description Summary
* Accountable for all country clinical/medical aspects associated with Development and prioritized Re-search programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative. May work across several countries.* Gathers, informs, and acts on clinical/medical/scientific insights for clinical trial concept sheets/protocols, Informed Consent Forms (ICFs) and other relevant clinical documents to optimize clinical trial implementation.
* 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.
* Accountable for adherence to safety standards and clinical data quality in the country by providing general clinical/medical support for trial related safety findings.
* In close collaboration with other country functions (e.g., clinical trial operations, Medical Affairs, Patient Engagement, and Patient Access) actively contributes 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:
Validates study designs, is accountable for, and makes the final decision on the clinical/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/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
Provides clinical/medical expertise to clinical trial operations team members and clinical trial sites for Institutional Review Boards (IRB)/ Ethics Committee (EC) interactions.
Decides on site/Country-specific scientific/clinical/medical content of the Informed Consent Form(ICF) as needed and ensures appropriateness of patient suitable language.
Provides scientific/clinical/medical expertise during interactions with Country/Cluster external Experts(e.g., Regulatory Authorities, Medical Experts, Advisory Boards, Patient Advocacy Groups, etc.).
Building disease area expertise, especially for new/rare indications.
Provides robust indication, compound, and protocol training: To the clinical operations team in the country, especially to the Clinical Research Associates, and other country line functions as needed.
Supports planning, implementation, and follow-up of scientific/clinical/medical components of Regulatory Authority inspections and internal audits.
Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.
May be involved in reviewing the clinical/medical aspects of clinical trial Serious Adverse Events (SAEs) occurring in the Country and supports the patient safety team, and Global as needed to ensure high quality of clinical/medical information.
Follows-up with the Investigator for additional clinical/medical information or clarifications for AEs and SAEs and provides clinical/medical expertise for safety amendments, Investigator Notifications (INs), Urgent Safety Measures (USM), etc. as needed.
Role Requirements:
Advanced degree (Doctorate) required; MD is preferred. Also open to PhD, PharmD, DO.
Specialty training in Oncology Radiation or Nuclear Medicine is required.
Proven track record of clinical experience in and scientific contributions to your field of expertise.
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/clinical perspective, and a demonstrated capability to problem solve and mediate complex scientific/clinical/medical/operational issues.
Ability to lead effectively by communicating well, motivating a cross-functional team, and handling and delegating responsibilities.
Demonstrates a 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 pro-vide medical context as it relates to disease processes, populations, and standards of care.
Ability to assess the feasibility of implementing the protocol based on Country/Cluster medical practice and sound understanding of the overall Clinical Development Plan.
Demonstrates a high level of understanding of the protocol to train others, including site personnel.
Demonstrates an understanding of the protocol to evaluate compliance on the part of the Investigator/site staff/study participant and any patient safety issues.
Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
Applies knowledge of Regulatory/industry requirements to work in a Country regulated environment.
Provides clinical, medical, and scientific expertise to facilitate the safe use of product(s) in clinical trials.
Applies safety expertise to answer clinical trial site safety questions and provides required information to Country/Global where appropriate.
Applies clinical/medical expertise to provide prompt review and follow-up on all SAEs and other safety documents relevant for clinical trial sites.
Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between: (non-MD range) $174,400 and 261,600/year and (MD range) $222,440 and 333,600/year; however, while salary ranges are effective from 1/1/24 through 12/31/24, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$222,400.00 - $333,600.00
Skills Desired
Budget Management, Clinical Research, Clinical Trial Protocol, Clinical Trials, Coaching, Cross-Functional Teams, Data Analysis, Learning Design, Lifesciences, Risk Management, Risk Monitoring
