Role Summary
Associate Clinical Research Medical Director - Rheumatology. 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.
Responsibilities
- 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
Qualifications
- Advanced degrees required; M.D., M.D. equivalent, Ph.D., or Pharm.D.
- Rheumatology subspecialty(Fellowship trained) or rheumatology clinical trial experience preferred
- 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.
Skills
- Clinical Trials
- Data Analysis
- Data Monitoring
- Drug Development
- Drug Discovery
- Medical Strategy
- People Management
Education
- Advanced degrees required; M.D., M.D. equivalent, Ph.D., or Pharm.D.
- Rheumatology subspecialty(Fellowship trained) or rheumatology clinical trial experience preferred
Additional Requirements