Senior Medical Director, Clinical Development Leader

Myana; Lexington (MA); Hybrid; USD 317,000 - 369,000; Full time

Job summary

Keros Therapeutics is seeking a Senior Medical Director to serve as the clinical development leader for one or more pipeline products. Reporting to the Executive Medical Director, you will guide asset identification through commercialization and collaborate with Clinical Sciences, Operations, Biostatistics, Safety, and CRO partners.

You will design robust clinical protocols, oversee medical monitoring, and contribute to regulatory submissions (INDs/CTAs, NDAs/MAAs) while leading cross-functional

Qualifications

• MD or equivalent degree with neurology background preferred.
• Minimum 5 years of clinical development experience.
• Strong communication, analytical and data presentation skills.

Responsibilities

• Lead clinical development on Program and Project Strategy Teams.
• Create and revise the Clinical Development Plan for global regulatory approval and market access.
• Design scientifically rigorous clinical protocols aligned with the CDP.
• Provide leadership on timely delivery of clinical programs with quality and scientific rigor.
• Lead/oversight of key documents (INDs/CTAs, NDAs/MAAs) with CDP alignment.
• Oversee Medical Monitor/Director and collaborate with Head of Safety.
• Collaborate with biostatistics, clinical sciences, and CRO partners for data analyses and safety reviews.
• Interact with regulatory authorities, KOLs, data monitoring committees, and advisory boards.

Skills

MD or equivalent

Neurology board certification (plus)

Communication skills

Analytical thinking

Travel flexibility

Hybrid work ability

Education

MD or equivalent

Board Certification in Neurology

Job description

Keros Therapeutics is seeking a Senior Medical Director to serve as the clinical development leader for one or more pipeline products. Reporting to the Executive Medical Director, you will guide asset identification through commercialization and collaborate with Clinical Sciences, Operations, Biostatistics, Safety, and CRO partners.

You will design robust clinical protocols, oversee medical monitoring, and contribute to regulatory submissions (INDs/CTAs, NDAs/MAAs) while leading cross-functional