Remote SVP, Clinical Affairs — Device & Drug Leader

NEXT Life Sciences, Inc.; United States; Remote; USD 280,000 - 300,000; Full time

Benefits offered by this job

Equity

Health, dental, and vision insurance

Unlimited PTO

Job summary

NEXT Life Sciences, Inc. seeks a Senior Vice President, Clinical Affairs to own clinical strategy and execution across its portfolio of medical devices and pharmaceutical products.

The SVP leads the clinical operations team, designs pivotal studies, and drives regulatory submissions from design through FDA approvals. The candidate will oversee CROs and budgets, manage safety reporting, and coordinate with the CEO, Board, and investors.

Qualifications

• 15+ years of clinical development experience in medical device/pharma/biotech.
• Leadership experience in clinical teams and CRO/vendor management.
• Experience leading FDA interactions and submissions (PMA/De Novo/510(k)/NDA).

Responsibilities

• Set clinical strategy and development plans for device and drug programs from first-in-human to approval.
• Lead the clinical operations team and build out the clinical organization as the pipeline grows.
• Design pivotal and supporting studies with endpoints, populations, statistics, and evidence packages.
• Direct device and drug clinical programs under IDE/IND and related regulatory submissions.
• Lead FDA interactions (pre-submission, pre-IND, End-of-Phase 2, pre-NDA) with regulatory.
• Oversee CROs, budgets, and vendor contracts to meet timelines and quality.

Skills

Clinical leadership

FDA interactions

Budget management

GCP/ICH/ISO 14155

Regulatory writing

Education

Bachelor’s degree in life sciences

PhD/MD ideal

Job description

NEXT Life Sciences, Inc. seeks a Senior Vice President, Clinical Affairs to own clinical strategy and execution across its portfolio of medical devices and pharmaceutical products.

The SVP leads the clinical operations team, designs pivotal studies, and drives regulatory submissions from design through FDA approvals. The candidate will oversee CROs and budgets, manage safety reporting, and coordinate with the CEO, Board, and investors.