Overview
Associate Clinical Research Medical Director CRM role at Novartis. This description presents responsibilities, qualifications, and expectations for the position.
Responsibilities
- Accountable for all country clinical/medical aspects associated with Development and prioritized research programs/trials by providing clinical strategic and tactical leadership as the Country Clinical Development representative.
- 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.
Major Accountabilities
- Provides Clinical Development and Indication Expertise specific to country, and 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 considering the broader ecosystem for assigned programs/trials, including identifying early on clinical challenges to recruitment or data quality and developing 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 on physician interviews, analysis of competitive trials, and patient engagement.
- Reviews and resolves country trial-related scientific/clinical/medical issues; initiates discussions with Global Clinical Development when necessary.
- Accountable for adherence to safety standards and 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 KPI targets, particularly related to feasibility and recruitment.
- Drives investigator site performance by providing high-quality support to investigators/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.
- Cardiology Subspecialty or cardiovascular clinical trial experience preferred
Experience / Professional Requirement
- Ability to manage a study from the scientific/medical/clinical perspective and demonstrate capability to solve problems 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.
- Strong problem-solving skills and comfort with complexity.
- Ability to prepare and deliver high-quality presentations.
- Ability to travel up to 30%.
- Typically 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.
Technical Competency
Protocol Execution
- Ability to assess the feasibility of implementing the protocol based on country medical practice and understanding of the overall Clinical Development Plan.
Regulatory & Compliance
- 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 products in clinical trials.
Compensation & Benefits
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 relevant skills and experience; upon joining, Novartis will review periodically. Salary ranges may change based on company and market factors. Compensation includes a performance-based cash incentive and, depending on the level of the role, eligibility for annual equity awards. US-based eligible employees will receive a comprehensive benefits package including health, life and disability benefits, a 401(k) with company contribution and match, and a generous time-off package.
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. Ready to create a brighter future together?
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Equal Opportunity
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
The Novartis Group of Companies are committed to providing reasonable accommodation to individuals with disabilities. If you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position, please email us with the job requisition number.
Seniority level
Employment type
Job function
- Research, Analyst, and Information Technology
Industries
- Pharmaceutical Manufacturing
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