General Summary:
- Define the clinical development strategy of povetacicept in primary membranous nephropathy; work with cross-functional teams to set overall asset and clinical trials strategy; design and execute clinical development; may serve as Medical Lead for trials.
Key Duties and Responsibilities:
- Define clinical development strategy and prepare clinical development plans with relevant functions.
- Contribute to study protocols, statistical analysis plans, investigatorβs brochures, and other study documents with minimal guidance.
- Lead project teams to define project strategy and ensure execution.
- Support regulatory submissions (IND/CTA clinical sections, safety reports, regulatory responses, clinical study reports).
- Interface with regulatory authorities.
- Monitor/oversee medical monitoring of clinical studies.
- Support 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 for efficient, high-quality execution and data analysis.
- Represent the company to outside medical personnel regarding protocols and conduct.
- People management may include financial accountabilities and HR responsibilities for assigned staff.
Knowledge and Skills (preferred/desired):
- Global clinical research experience; experience interacting with regulatory authorities.
- Collaborative in a fast-paced matrix environment; independent problem-solving.
- Enterprise-wide thinking; ability to work in ambiguity; ensure completeness of team work.
- Excellent oral and written communication.
- Board certification/eligibility in a specialty (highly desired).
Education and Experience (required/desired):
- MD, DO, or equivalent ex-US medical degree.
- Board certification/eligibility (highly desired).
- Typically 12 years in pharma/biotech with experience managing clinical trials and development programs (or equivalent combination).
- Supervisory experience required.
Benefits/Compensation (if explicitly stated):
- $280,600 - $420,800 base pay range; eligible for annual bonus and annual equity awards.
Application Instructions:
- Contact Talent Acquisition at ApplicationAssistance@vrtx.com for application-process accommodations.