Director, Clinical Sciences

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

Job summary

Keros Therapeutics, Inc. seeks a Director of Clinical Sciences to lead the KER-065 program or other studies. You will design and initiate trials, support data review, interpret results, and drive development from concept to regulatory-ready documents.

This role requires collaboration with the VP and Medical Director, and involves travel. The position is based in Lexington with expectations for domestic and international travel.

Qualifications

• Strong leadership and communication skills with proficiency in understanding, analyzing, and presenting scientific data.
• Detailed understanding of all aspects of clinical trial design and data interpretation.
• Experience in regulatory submissions and NDA/BLA filings is preferred.
• Ability to work in a highly matrixed, multidisciplinary team.
• Willingness to travel up to 20% and be in the Lexington office 2–3 times per week.

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, regulatory documents including INDs/CTAs, NDAs/MAAs) with high quality and consistency with the Clinical Development Plan.
• Collaborate with biostatistics, clinical development, and other applicable team members to participate in data analyses and presentations for safety monitoring committee meetings, regulatory documents, and internal reviews.
• Contribute to the study medical/safety aspects and risk-benefit assessments, collaborating with Pharmacovigilance.
• Plan and lead ongoing medical data review with data management and other functions.
• Work with Clinical Operations to balance medical quality, trial complexity, and time/cost considerations.
• Prepare clinical sections of key documents (Investigator's Brochures, IND summaries, CTAs, regulatory responses, IRBs, NDAs).
• Contribute to CSR medical content and guidance to team members as needed.
• Develop and update key messages on disease states, MOA, and target product profile.
• Collaborate with Medical Affairs on scientific communications, publications, and congress management.
• Author and review abstracts, posters, and manuscripts for publication.

Skills

Leadership

Communication

Clinical data analysis

Education

Doctorate (MD, PhD, PharmD or equivalent)

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

This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, and other relevant factors.

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.

Keros Therapeutics does not accept unsolicited resumes from any source other than the candidate directly. Any unsolicited submission by an agency to Keros is prohibited. Any resume submitted by an agency without a signed contract or expressed consent by a member of the Keros Therapeutics Human Resources Department, will be considered property of Keros Therapeutics, and no fee shall be owed with respect thereto.