Senior Medical Director/Scientific Director, US Medical Affairs-Rheumatology
$182,000–$346,000 year
HybridMettawa, Illinois, United States
Job Summary
Initiate medical affairs activities by generating and disseminating data supporting scientific strategy. Design, analyze, interpret, and report scientific content for protocols, Investigator Brochures, Clinical Study Reports, and regulatory submissions. Oversee Medical Affairs-led clinical studies, monitoring study integrity, enrollment, and timelines while reviewing accumulating safety and efficacy data. Provide in-house clinical expertise by coordinating scientific activities with internal stakeholders and partnering on translational strategies. Act as a clinical interface to solicit opinions from leaders, ensuring cross-functional perspectives are incorporated into Clinical Development Plans. Develop scientifically accurate marketing materials, medical education programs, and advisories. Interact with internal stakeholders to coordinate scientific activities and serve as the scientific team interface for key regulatory discussions. Provide scientific/medical education to investigators and Global Project Team members while keeping abreast of professional information through conferences and literature. Ensure budgets, timelines, and compliance requirements are factored into programs' scientific activities.
Required Qualifications
- Advanced Degree PhD or PharmD
- 7-10 years of experience in Medical Affairs
- Global Medical Affairs experience
- 10-15 years of experience in the pharmaceutical industry
- Substantial understanding of relevant therapeutic area
- Minimum of 4 years of clinical trials direct management experience
- Knowledge of clinical trial methodology
- Knowledge of data analysis
- Knowledge of interpretation
- Knowledge of regulatory requirements governing clinical trials
- Experience in development strategy
- Experience in the design of protocols
- Ability to run a clinical study independently
- Proven leadership skills in a cross-functional global team environment
- Excellent oral and written English communication skills
Desired Qualifications
- Additional post doctorate experience
- Clinical trials direct management experience in the pharmaceutical industry or academia or equivalent
- 4+ years of experience
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