摘要
• 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 and Patient Engagement) actively contributes to successful allocation, fast clinical trial start-up, timely recruitment, early identification of potential delays, and development and implementation of mitigation plans.
About the Role
Major Accountabilities
From Strategy to Functional Excellence
Provides Clinical Development and indication expertise specific to Country, and together with the clinical trial operations team, drives the execution of clinical trials with high quality and within planned timelines:
- Actively contributes to scientific/clinical/medical aspects of the start-up phase to ensure fast clinical trial site start-up.
- Develops clinical/medical trial plans taking the broader ecosystem into account for assigned programs/trials to ensure successful trial implementation, which includes:
- Pro-actively identifying early on clinical challenges to recruitment or clinical data quality and drives development of clinical/medical mitigation plans.
- Provides robust indication, compound, and protocol training
- Leverages innovation in clinical trial planning and decides on clinical/medical recruitment strategy and implementation based upon physician interviews, analysis of competitive trials, and patient engagement.
- Reviews and resolves Country trial-related scientific/clinical/medical issues/questions. If necessary, initiates the discussion with the Global Clinical Development team.
- Accountable for adherence to safety standards, clinical data quality for the Country and provides general scientific/clinical/medical support for safety issues
Key performance indicators/Measures of success
- Meets Country specific clinical trial operations Key Performance Index (KPI) targets, particularly those related to trial feasibility and recruitment.
- Drives investigator site performance by providing high quality support to Investigators/Clinical trial site staff for Development and Biomedical Research studies, leading to a superior customer experience.
- Quality of scientific/clinical/medical input to Country and Global teams.
Ideal Background
Education
- Advanced degrees required; M.D., M.D. equivalent, Ph.D., or Pharm.D.
- Nephrology Subspecialty or Renal clinical trial experience preferred
Experience/Professional Requirement:
- 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.
- 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.
- Ability to travel up to 30%
- 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.
Details of Technical Competency
Protocol Execution:
- Ability to assess the feasibility of implementing the protocol based on Country medical practice and sound understanding of the overall Clinical Development Plan.
Regulatory & Compliance:
- Demonstrates an understanding of Regulatory requirements and internal policies, procedures, and guidelines pertaining to clinical trials.
Safety Monitoring:
- Provides clinical, medical, and scientific expertise to facilitate the safe use of product(s) in clinical trials.
The salary for this position is expected per the following:
- Non-MD range $174,400 and $261,600/year
- MD range $222,440 and $333,600/year
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? http://www.novartis.com/about/strategy/people-and-culture
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. 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.
Accessibility & 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 [email protected] 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.
