Executive Director, Clinical Development Lead

Moderna; Cambridge (MA); On-site; USD 260,000 - 380,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Moderna is seeking a Senior clinical development physician (MD) to lead oncology drug development programs, shaping clinical strategy, study design, protocol writing, and monitoring within the biopharma industry.

You will develop integrated development plans, optimize trial designs, generate efficacy and safety evidence, and drive cross-functional collaborations across Research, Regulatory, Clinical Operations, and Commercial teams.

Qualifications

• MD with 10+ years in clinical development, including 5+ years in industry, with oncology or IO expertise.
• Strong knowledge of clinical trial methodology, biostatistics, and regulatory guidelines (FDA, ICH GCP).
• Excellent communication, organizational, and problem-solving skills.

Responsibilities

• Develop integrated clinical development plans and lead cross-functional collaborations.
• Lead as scientific leader, manage risk/benefit assessments, and contribute to regulatory submissions.
• Oversee IO and mRNA therapy trial execution, evidence generation, and innovative solutions adoption.

Skills

Clinical development

Immuno-oncology

Cross-functional leadership

Regulatory guidance (FDA, ICH GCP)

Education

MD degree

Job description

Role

Senior clinical development physician (MD) leading oncology drug development programs at Moderna, with medical responsibility for clinical strategy, study design, protocol writing, and monitoring in the biopharma industry.

Responsibilities

• Develop integrated clinical development plans, optimize study designs aligned with regulatory and commercial goals, generate efficacy and safety evidence, and lead cross-functional collaborations across Research, Regulatory, Clinical Operations, and Commercial teams.
• Serve as scientific leader influencing external experts and internal teams, manage risk/benefit assessments, and contribute to regulatory submissions (IND, BLA, MAA).
• Oversee technical and strategic aspects of immuno-oncology and mRNA-based therapies, including trial execution, evidence generation, and innovative solutions adoption.

Requirements

• MD with 10+ years in clinical development, at least 5 in industry, with expertise in immuno-oncology or oncology, and experience leading cross-disciplinary teams.
• Strong understanding of clinical trial methodology, biostatistics, and regulatory guidelines (FDA, ICH GCP).
• Excellent communication, organizational, and problem solving skills.

Preferred

• Experience with AI/machine learning in drug development.
• Regulatory inspections, and global trial conduct.

High-value specifics

• Oncology, immuno-oncology, mRNA therapies.
• Clinical development stage from early to late-phase.
• Cross-functional leadership.

Work setup

In-office/hybrid model, with emphasis on collaboration.