Clinical Development Senior Medical Director-Neurology

General Summary:
- Define the clinical development strategy of an asset; work with cross-functional teams to set overall asset and clinical trials strategy; design and execute trials; may serve as Medical Lead.

Key Duties and Responsibilities:
- Define clinical development strategy and prepare clinical development plans.
- Develop study protocols, statistical analysis plans, investigator’s brochures, and key study documents with minimal guidance.
- Lead project team; define project strategy and ensure execution against approved strategy.
- Support regulatory submissions (IND/CTA clinical sections, safety reports, regulatory responses, clinical study reports).
- Interface with regulatory authorities.
- Monitor and/or oversee medical monitoring of clinical studies.
- Participate in business development and strategic planning.
- Act as liaison between clinical development and internal groups for assigned studies.
- Provide medical/development leadership for cross-functional teams.
- Serve on cross-functional study teams to support high-quality execution and data analysis.
- Represent company with outside medical personnel regarding protocol development and study conduct.

Knowledge and Skills (Required/Preferred):
- Global clinical research experience; regulatory authority interaction highly desired.
- Collaborative in a fast-paced, matrix environment; independent problem solving.
- Enterprise-wide thinking; able to work in ambiguity.
- Ensure completeness of team work.
- Excellent oral and written communication.
- Board certification/eligibility highly desired.

Education and Experience:
- MD/DO or equivalent non-US medical degree.
- Typically 12 years pharmaceutical/biotech industry experience, including managing clinical trials and clinical development programs.

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

Flex Designation:
- Hybrid-Eligible or On-Site Eligible (Hybrid: remote up to 2 days/week; On-Site: 5 days/week on-site with ad hoc flexibility).