Senior VP, FcRn & Immunology Clinical Development

Viridian Therapeutics, Inc.; Waltham (MA); Híbrido; USD 350 000 - 600 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Stock options

Insurance (medical, dental, vision)

Disability plan

Life & AD&D

401(k) company match

Employee stock purchase plan

Generous vacation plan

Wellness programs

Resumo da oferta

Viridian Therapeutics, Inc. in Massachusetts seeks an accomplished SVP, Clinical Development (FcRn/immunology) to set strategy and lead execution across programs.

You will supervise clinical development teams, shape trial concepts, and interact with regulatory bodies to advance INDs, NDAs/BLAs through registrations and lifecycle management. Based in Waltham, MA, this office-based role requires you to work on-site three days a week and provide leadership across cross-functional teams while

Qualificações

• Requires an MD with 20+ years in clinical development and medicine.
• Experience leading late-stage or registrational programs in biopharma.
• Proven ability to present strategy and data to executives and external stakeholders.
• Strong cross-functional leadership and talent development skills.

Responsabilidades

• Lead FcRn/immunology clinical development programs and strategy.
• Oversee study concepts, protocols, CSRs and regulatory document preparation.
• Ensure data interpretation, programming for regulatory submissions and lifecycle management.
• Collaborate with Clinical Operations, Data Management, Biometric Sciences and Regulatory Affairs.
• Mentor a team of Clinical Development Leads and Scientists.
• Ensure adherence to GCP and regulatory requirements and manage budgets.

Conhecimentos

Strategic leadership

Clinical development

Regulatory strategy

Team management

Immunology expertise

Formação académica

MD degree

Ferramentas

Microsoft Office

Descrição da oferta de emprego

Viridian Therapeutics, Inc. in Massachusetts seeks an accomplished SVP, Clinical Development (FcRn/immunology) to set strategy and lead execution across programs.

You will supervise clinical development teams, shape trial concepts, and interact with regulatory bodies to advance INDs, NDAs/BLAs through registrations and lifecycle management. Based in Waltham, MA, this office-based role requires you to work on-site three days a week and provide leadership across cross-functional teams while