Senior Medical Director
Keros Therapeutics
September 04, 2026
Remote friendly (Lexington, MA)
United States
Medical Affairs
Senior Medical Director (rinvatercept) — Neuromuscular (DMD, ALS)
Primary Responsibilities
- Lead clinical development strategy for rinvatercept: develop the clinical development plan (CDP) and design future trials.
- Identify and mitigate program-level risks; provide oversight and hands-on execution to ensure quality delivery and timelines.
- Author/advise on regulatory submission sections and related documents (e.g., responses to queries).
- Represent the company with health authorities; participate in business development by evaluating in-licensing opportunities (when requested).
- Provide medical leadership to trial teams; communicate progress, risks, and emerging data.
- Lead/supervise trial committees (Safety Review Committee, DSMB, Steering Committee, as appropriate).
- Oversee authoring of protocols, amendments, Investigator’s Brochure updates, publications, and final clinical study reports.
- Lead KOL advisory meetings; align study designs and CDPs with the therapeutic landscape and patient/research needs.
Qualifications
- MD/DO (or equivalent) required.
- Neurology/Pediatric Neurology (or related) board eligibility/certification desired.
- Strong GCP knowledge and clinical/regulatory pathways.
- 5+ years clinical drug development in biopharma required; Phase 3 design and BLA drafting a plus.
- 3+ years clinical practice preferred (fellowship acceptable).
- Trial medical lead experience required; pediatric and/or rare indication trials desired; neuromuscular trials preferred.
Skills/Attributes (required unless noted)
- Exceptional neuromuscular medical/scientific knowledge (desired) and ability to learn new indications.
- Strategic/analytical problem-solving; strong communication (written/verbal/presentations); leadership and influence; emotional intelligence and collaboration.
- On-site in Lexington, MA at least 3 days/week.
Potential base pay range: $332,000—$381,000 USD.
Primary Responsibilities
- Lead clinical development strategy for rinvatercept: develop the clinical development plan (CDP) and design future trials.
- Identify and mitigate program-level risks; provide oversight and hands-on execution to ensure quality delivery and timelines.
- Author/advise on regulatory submission sections and related documents (e.g., responses to queries).
- Represent the company with health authorities; participate in business development by evaluating in-licensing opportunities (when requested).
- Provide medical leadership to trial teams; communicate progress, risks, and emerging data.
- Lead/supervise trial committees (Safety Review Committee, DSMB, Steering Committee, as appropriate).
- Oversee authoring of protocols, amendments, Investigator’s Brochure updates, publications, and final clinical study reports.
- Lead KOL advisory meetings; align study designs and CDPs with the therapeutic landscape and patient/research needs.
Qualifications
- MD/DO (or equivalent) required.
- Neurology/Pediatric Neurology (or related) board eligibility/certification desired.
- Strong GCP knowledge and clinical/regulatory pathways.
- 5+ years clinical drug development in biopharma required; Phase 3 design and BLA drafting a plus.
- 3+ years clinical practice preferred (fellowship acceptable).
- Trial medical lead experience required; pediatric and/or rare indication trials desired; neuromuscular trials preferred.
Skills/Attributes (required unless noted)
- Exceptional neuromuscular medical/scientific knowledge (desired) and ability to learn new indications.
- Strategic/analytical problem-solving; strong communication (written/verbal/presentations); leadership and influence; emotional intelligence and collaboration.
- On-site in Lexington, MA at least 3 days/week.
Potential base pay range: $332,000—$381,000 USD.