Medical Director, Medical Development
The Medical Director, Medical Development is responsible for the design, plan and execution of clinical trials, and running of programs focused on assigned therapeutic areas, in accordance with applicable regulatory and quality standards, and company timelines and budgets. Activities are geared toward ensuring that all clinical activities related to clinical trials are managed effectively in support of regulatory submissions and subsequent approval.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. Requirements
Education and Experience
- MD and US medical license, with 14+ years of clinical drug development related experience in the research and development of novel biologics, particularly within the field of inflammation.
- Expertise in preclinical, translational and early clinical development within the field of inflammation
- Extensive academic and pharma collaborative network. History of personal interaction with thought leaders in the inflammation field.
- Track record of program leadership and achievement of goals and deliverables, of effective collaboration, effectiveness in team settings, and team leadership
Knowledge and Competencies
- Firm understanding of the mechanistic basis of human inflammatory disorders
- Thorough understanding of clinical protocols and regulatory processes
- Excellent understanding of the drug development process
- Thorough knowledge of FDA requirements, Good Clinical Practices, and pharmaceutical clinical development.
- Demonstrated success establishing, communicating and driving a vision and strategy for a therapeutic area/product, and develop an integrated plan of action including milestones and endpoints
- Viewed as a leader within the therapeutic area/disease state and considered a scientific contributor and innovator within internal and external spheres of influence.
- The ability to think globally, strategically and be innovative regarding the future of the disease state and company’s therapeutic agents and possess a solid understanding of the pharmaceutical industry, company competition and commercial side of business, including Marketing and Sales, Market Access, Pricing/Reimbursement, Business Development, Medical Affairs and Supply Chain