Clinical Development Senior Medical Director- gMG

General Summary:
The Senior Medical Director will define the clinical development strategy of an asset, work with cross-functional multidisciplinary teams to define overall asset strategy as well as clinical trials strategy, design and execution, and may serve as the Medical Lead for clinical trials.

Key Duties and Responsibilities:
- Define clinical development strategy and prepare clinical development plans
- Develop study protocols, statistical analysis plans, investigator’s brochures, and other key study documents
- Lead the Project Team; define project strategy and ensure execution
- Prepare regulatory documents for submissions (e.g., clinical sections of INDs/CTAs), safety reports, regulatory responses, and clinical study reports
- Interface with regulatory authorities as appropriate
- Monitor and/or oversee medical monitoring of clinical studies
- Participate in business development and strategic planning activities
- Liaison between clinical development and internal groups for assigned studies
- Provide medical and development leadership for cross-functional teams
- Serve on cross-functional study teams to support study execution and data analysis
- Represent the company with outside medical personnel regarding clinical protocols and study conduct

Knowledge and Skills (Required/Highly Desired):
- Global clinical research experience and regulatory authority interaction (highly desired)
- Collaborative in fast-paced matrix environment
- Independent problem-solving; work in ambiguity
- Ensure completeness of team work
- Excellent oral and written communication skills
- Board certification/eligibility in a specialty (highly desired)

Education and Experience:
- MD, DO or equivalent ex-US medical degree
- Typically 12 years Pharmaceutical/Biotech industry experience, including managing clinical trials and clinical development programs

Pay Range:
- $280,600 - $420,800