Director, Clinical Sciences

Keros Therapeutics•Lexington, MA

13h•$200,000 - $241,000•Hybrid

About The Position

Keros Therapeutics is seeking a Director of Clinical Sciences to serve as lead Clinical Scientist for the KER-065 program or another assigned study. Reporting to the VP, Clinical Development Operations, this role designs and initiates clinical trials, supports clinical data review and interpretation, and helps advance compounds through development. The Director partners with the VP and/or Medical Director on study activities, clinical development plans, target product profiles, cross-functional work, and data quality, including CRF data collection, monitoring, and cleaning, and generation of data outputs. The position is based in Keros’s Lexington office, requires attendance in the office at least two to three times per week, and involves domestic and international travel of up to 20%. The role works across clinical development, clinical operations, biostatistics, pharmacovigilance, data management, Medical Affairs, and other internal and external stakeholders.

Requirements

Doctorate (MD, PhD, PharmD, or equivalent).
At least 5 years of clinical development experience in the pharmaceutical or biotechnology industry.
Detailed understanding of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development.
Working knowledge of the IND/NDA process.
Strong leadership and communication skills, and demonstrated ability to understand, analyze, and present scientific and clinical data.
Ability to work collaboratively in a highly matrixed, multidisciplinary team and help an innovative organization succeed.
Ability to engage and collaborate with diverse internal and external stakeholders, including executive leadership, study investigators, KOLs, and the external medical and scientific community.
Ability to work in the company office at least 2–3 times per week.
Ability to travel up to 20%.

Nice To Haves

Direct experience with NDA/BLA filings.
Experience developing therapies for neuromuscular or neurodegenerative indications (preferred but not required).
Genuine interest in and understanding of the science supporting the pipeline.

Responsibilities

Serve as lead Clinical Scientist for the KER-065 program or another assigned program and represent clinical sciences in cross-functional team meetings.
Lead and support the creation of clinical trial protocols, Investigator’s Brochures, Clinical Study Reports, regulatory documents, and regulatory responses, ensuring quality and consistency with the Clinical Development Plan.
Collaborate with biostatistics, clinical development, and other team members on timely data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews to support program decisions.
Contribute to study medical and safety activities and risk-benefit assessments in collaboration with Pharmacovigilance.
Plan and lead ongoing medical data review with data management and other functions.
Partner with Clinical Operations on patient-centric drug development, balancing medical quality, trial complexity, time, and cost.
Own and ensure preparation of clinical sections of key documents, including Investigator’s Brochures, IND summary documents, CTAs, responses to regulatory authorities, IRBs and ethics committees, and NDAs.
Contribute medical content to Clinical Study Reports and provide guidance to other team members as needed.
Develop and update key messages on disease states, mechanism of action, target product profile, and the scientific platform.
Collaborate with Medical Affairs and other team members on scientific communication of clinical data, external messaging, publication planning, and congress management.
Author and review abstracts, posters, and manuscripts for publication.
Lead, contribute to, and drive initiatives aligned with functional goals and corporate objectives.