Chief Medical Officer - Nephrology Drug Development

Clinical Dynamix, Inc.; Jersey City (NJ); Presencial; USD 300.000 - 600.000; Jornada completa

Descripción de la vacante

Clinical Dynamix, Inc. seeks a Chief Medical Officer to partner with the CEO and guide the company’s drug development from preclinical to regulatory milestones, prioritizing programs and accelerating candidates.

The CMO will represent the company to regulators and investors and build a high-performing clinical team. The role requires extensive senior-level experience in clinical development, leadership and a strong track record with nephrology-focused programs, IND/NDA submissions, and global

Formación

• Senior-level experience in clinical development in pharma/biotech.
• Thorough understanding of drug development and registration processes.
• MD or MD/PhD in Nephrology/Internal Medicine required.

Responsabilidades

• Provide leadership and clinical perspective to research, development, quality and regulatory strategies.
• Manage overall clinical development for lead programs from early development to pivotal studies and regulatory submissions.
• Ensure Company meets its clinical and regulatory milestones.
• Represent Company at FDA, EMEA and other regulatory agencies.
• Maintain understanding of competitors and developments by attending meetings and tracking literature.
• Represent and manage clinical and regulatory programs to diverse audiences including FDA, shareholders, partners and Board members.
• Lead interactions with the scientific and business communities at conferences and collaborations.
• Establish and foster relationships with key opinion leaders and international medical community.
• Assist in seeking product and technology alliances to accelerate development of assets.
• Establish collaborations with partners in academia, government and industry.

Conocimientos

Leadership

Regulatory experience

Clinical development

Communication

Stakeholder management

FDA/EMA interactions

Educación

MD or MD/PhD (Nephrology/Internal Medicine)

Descripción del empleo

Clinical Dynamix, Inc. seeks a Chief Medical Officer to partner with the CEO and guide the company’s drug development from preclinical to regulatory milestones, prioritizing programs and accelerating candidates.

The CMO will represent the company to regulators and investors and build a high-performing clinical team. The role requires extensive senior-level experience in clinical development, leadership and a strong track record with nephrology-focused programs, IND/NDA submissions, and global