Director, Clinical Sciences

Keros Therapeutics, Inc.; Lexington (MA); On-site; USD 200,000 - 241,000; Full time

Job summary

Keros Therapeutics, Inc. is seeking a Director of Clinical Sciences to lead the KER-065 program or other studies from Lexington, MA. This role designs and initiates clinical trials, reviews data, and drives development through regulatory submissions while collaborating with Medical Affairs and cross-functional teams.

Travel up to 20% is required. The candidate will draft clinical development plans, target product profiles, and ensure high data quality across study activities, including CRF data

Qualifications

• Strong understanding of clinical trial design, methodology and regulatory submissions (IND/NDA).
• Experience leading cross-functional teams in a matrixed environment.
• Ability to interpret study results and drive development strategy.
• Excellent communication and leadership skills for collaboration with stakeholders.
• Willingness to travel up to 20% and work in Lexington, MA office.

Responsibilities

• Lead clinical scientist for the KER-065 program or other studies, representing clinical sciences in cross-functional meetings.
• Draft and oversee key documents (protocols, CSRs, IND/CTA/NDA documents) to ensure quality and regulatory readiness.
• Collaborate with biostatistics, clinical development, and other teams for timely data analyses and safety reviews.
• Oversee data quality activities (CRFs, data monitoring, data cleaning) and generate outputs.
• Support clinical development plans, target product profiles, and external scientific communications.
• Contribute to CSR medical content and guide junior team members as needed.

Skills

Clinical development

Leadership

Regulatory submissions

Data analysis

Trial design

Cross-functional collaboration

Education

Doctorate (MD, PhD, PharmD or equivalent)

5+ years clinical development experience

Job description

At Keros, our mission is to deliver significant clinical benefit to a wide range of patients with disorders that are linked to dysfunctional signaling of the transforming growth factor-beta (TGF-ß) family of proteins. With a focus on developing differentiated product candidates that are designed to alter TGF-β signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. We believe our product candidates have the potential to unlock the full therapeutic benefits of modulating the TGF-β superfamily and provide disease-modifying benefit to patients.

Job Summary:

Reporting to the VP, Clinical Development Operations, the Director of Clinical Sciences will serve as the lead Clinical Scientist for the KER-065 program or other assigned study. This person will be responsible for designing and initiating clinical trial(s), supporting clinical data review, interpretation of study results and drive a compound through development. The Director of Clinical Sciences will work closely with the VP, Clinical Development Operations and/or the Medical Director to support various study related activities including drafting clinical development plan, target product profile and represent clinical sciences/development in cross functional teams. In addition, they will contribute to workstreams overseeing data quality, including those involved in CRF data collection, data monitoring and cleaning, and generation of data outputs. This position is based in the company’s Lexington office and requires some domestic and international travel.

Responsibilities

• Function as the lead Clinical Scientist for the KER-065 program or other assigned program and represent clinical sciences in cross function team meetings.
• Lead and support creation of key documents (e.g., Clinical Trial Protocols, Investigator’s Brochures, Clinical Study Reports (CSRs), regulatory documents including INDs/CTAs, NDAs/MAAs and regulatory responses) with high quality and consistency with the Clinical Development Plan.
• Collaborate with biostatistics, clinical development, and other applicable team members to participate in relevant and timely data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews to support timely program decisions regarding study objectives.
• Contribute to the study medical/ safety aspects and risk-benefit assessments, collaborating closely with Pharmacovigilance team.
• Plan and lead ongoing medical data review in collaboration with data management and other functions.
• Work hand-in-hand with the Clinical Operations team for patient centric drug development, ensuring balancing of high medical quality, trial complexity, as well as time and cost considerations.
• Own and ensure preparation for clinical sections of key documents, including Investigator's Brochures, IND summary documents, CTAs, responses to questions from regulatory authorities, IRBs and ethics committees, and NDAs.
• Contribute to Clinical Study Report (CSR) medical content to ensure high quality expectations on medical standards, provides respective guidance to other members, if needed
• Work with the internal team to develop and update key messages on disease states, MOA, target product profile, and scientific platform.
• Collaborate with Medical Affairs and other team members on scientific communication of clinical data, including external messaging, publication planning, and congress management.
• Author and review abstracts, posters, and manuscripts for publication.
• Lead, contribute and drive other initiatives based on the functional goals and corporate objectives.

Qualifications

• Genuine interest and understanding of the science supporting the pipeline
• Ability to work collaboratively in a highly matrixed, multidisciplinary team setting, and an innovative drive to help the organization succeed
• Strong leadership and communication skills and proven proficiency in understanding, analyzing, and presenting scientific and clinical data
• Detailed understanding of all aspects of clinical trial design, methodology, statistical concepts, protocol development and implementation, global regulatory submissions, and overall drug development is required
• Working knowledge of the IND/NDA process is required. Direct experience with NDA/BLA filings is preferred
• Ability to engage and collaborate with diverse stakeholder groups internally and externally, including executive leadership, study investigators, KOLs, and the external medical and scientific community
• Ability to be in the company office at least 2-3 times per week
• Ability to travel up to 20% required

Education and Experience

• Doctorate (MD, PhD, PharmD or equivalent) required; experience developing therapies for neuromuscular/neurodegenerative indications is preferred but not required
• Minimum of 5 years of clinical development experience in the pharmaceutical or biotechnology industry is required

Potential base pay range

$200,000 — $241,000 USD

Our Diversity, Equity & Inclusion Mission Statement:

Keros is an inclusive company. We believe that diversity drives innovation. We continue to build an inclusive culture that encourages, supports, and celebrates the diverse voices of our employees. As such, Keros takes a holistic approach in mentoring, coaching, and developing all of our Keros team members.

Keros Therapeutics is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.