Director, Clinical Development

Scorpion Therapeutics; United States; On-site; USD 240,000 - 310,000; Full time

Job summary

Scorpion Therapeutics is seeking a Director of Clinical Development to lead product development from early trials through regulatory approval, with oversight across cardiometabolic and hepatology programs. The role collaborates with Clinical Operations, Regulatory, Biostats, and Medical Affairs to align strategy and ensure scientific integrity.

The candidate will interpret trial results, contribute to regulatory submissions, and mentor teams, providing SVP-level input on program design and

Qualifications

• MD board-certified is required.
• Formal cardiometabolic and/or hepatology training preferred.
• 5+ years in industry or combined industry/academic experience.
• Experience across all stages of clinical development and trial management.
• Strong ability to communicate complex information to senior leadership.

Responsibilities

• Champion product(s) under development; SME.
• Oversee clinical programs and trials (ICH/GCP).
• Partner with Clinical Operations for compliant study execution.
• Review data; support reports and publications.
• Coordinate with CROs and external vendors.
• Provide leadership updates; develop/implement clinical trial SOPs.

Skills

Cardiometabolic expertise

Project planning

Leadership

Negotiation

Presentation skills

Regulatory familiarity

Education

MD board-certified

Cardiometabolic and/or hepatology training

Job description

Description

The Director, Clinical Development provides clinical leadership for product(s) in development, including design, planning, execution, scientific integrity, and medical oversight of clinical studies across all phases and therapeutic areas (including cardiometabolic and hepatology) from early clinical development through regulatory approval. Collaborates cross-functionally (Clinical Operations, Pharmacovigilance, Regulatory Affairs, Medical Affairs, Biostats, Quality Assurance, Program Management, Preclinical Development) to ensure aligned strategy and execution. Oversees medical monitors; provides medical input to documents (e.g., IB, IMPD, DSUR, SUSAR, IND, NDA/BLA, PIP). Interprets and disseminates results (clinical study reports, publications, and conference/regulatory presentations). Contributes to overall clinical strategy and ensures regulatory compliance. Supports translational medicine efforts in assigned TA and provides SVP-level input on program design and strategic/tactical plans.

Responsibilities

• Champion product(s) under development; serve as SME
• Keep current on literature, competitive environment, and regulatory guidelines
• Oversee/manage clinical programs and trials (ICH/GCP and Wave SOPs)
• Partner with Clinical Operations to ensure compliant study execution
• Review clinical data; support study reports and publications
• Coordinate with internal departments and external vendors (e.g., CROs)
• Serve as study medical monitor (as needed); build site/HCP/KOL relationships
• Represent Wave with regulatory agencies; support budgeting/financial planning
• Provide leadership updates; develop/implement clinical trial SOPs
• Ensure global regulatory compliance; interface with Finance/Legal and others
• Analyze/present data; may mentor/manage matrix and direct reports

Experience & Qualifications

• Board-certified MD (required)
• Formal cardiometabolic and/or hepatology training (preferred)
• 5+ years industry or combined industry/academic experience
• Experience across all stages of clinical development; clinical trial management from inception to completion including study design
• Significant experience communicating/presenting complex information to senior leadership

Key Skills

• Strong cardiometabolic scientific background
• Project planning, leadership, negotiation, presentation; creative/practical problem solving
• Knowledge of FDA and ICH regulations
• Clinical medicine and clinical pharmacology (incl. biostatistics, data management, medical writing)
• Familiarity with Good Clinical Practice (GCP)