Director, Clinical Science (Biotech)

TL;DR

Director, Clinical Science (Biotech): Advancing innovative therapies for rare and complex diseases with an accent on clinical study design, execution, and interpretation across nephrology programs. Focus on bridging clinical operations, regulatory strategy, and translational science to deliver new treatment options for patients with unmet medical needs.

Location: Remote (Must be based in the United States)

Salary: $206,000 – $268,000

Company

A science-driven organization focused on developing innovative therapies for rare and complex diseases, particularly within nephrology.

What you will do

• Support the design and implementation of clinical studies, including human pharmacology, ensuring scientifically sound methodologies.
• Analyze and interpret clinical trial data to derive insights on safety, efficacy, and mechanism of action.
• Lead the preparation of critical regulatory documents, including INDs, NDAs, BLAs, protocols, and SAPs.
• Ensure full compliance with Good Clinical Practices (GCP) across all study design and documentation activities.
• Collaborate with cross-functional teams in biostatistics, clinical operations, and regulatory affairs for submission readiness.
• Build and maintain strategic relationships with external investigators, alliance partners, and key opinion leaders.

Requirements

• Advanced degree (PhD, PharmD, and/or MD) in a relevant life sciences discipline.
• 6–8+ years of experience in the pharmaceutical or biotechnology industry, or academic clinical research.
• Demonstrated expertise in clinical trial design and execution, with a preference for early-phase (human pharmacology) studies.
• Knowledge of regulatory processes and prior involvement in IND, NDA, or BLA submissions.
• Must be based in the United States.
• Willingness to travel domestically and internationally as needed (up to 15%).

Culture & Benefits

• Competitive base salary with short-term incentives and long-term equity opportunities.
• Comprehensive health, dental, vision, life, and disability insurance for employees and dependents.
• Retirement savings plan with employer matching contributions.
• Generous paid time off and holidays to support work-life balance.
• Access to employee wellness programs and professional support resources.
• High-impact leadership role with visibility across clinical development and regulatory functions.