What are the responsibilities and job description for the Clinical Scientist position at Keros Therapeutics?
Keros Therapeutics is a public, clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from hematological and musculoskeletal disorders with high unmet medical need. We are a leader in understanding the role of the transforming growth factor-beta, or TGF-, family of proteins, which are master regulators of red blood cell and platelet production as well as of the growth, repair and maintenance of muscle and bone. We have leveraged this understanding and developed a discovery approach to generate large and small molecules to address diseases of these tissues. Targeting TGF- signaling pathways has been clinically proven to elicit robust changes in blood cells, muscle, and bone, which we believe provides a precedent and strong rationale for our strategy.
The Clinical Scientist will participate on a cross-functional team, developing an understanding of the product, the therapeutic space, and the clinical studies to which they are assigned in order to support various clinical study activities. They will work closely with the Director of Clinical Sciences and/or the Medical Director to support the review, analysis, and interpretation of clinical trial data. In addition, the Clinical Scientist will contribute to workstreams overseeing data quality, including those involved in CRF data collection, data monitoring and cleaning, and generation of data outputs.
Essential Functions/Responsibilities
- Support the Director of Clinical Sciences, Study Physician/s and cross-functional study management teams in clinical studies including review and interpretation of clinical trial data and timely execution of deliverables in collaboration with relevant internal and external partners
- Support the Director of Clinical Sciences and Study Physician to participate in relevant and timely data analyses and presentations in collaboration with safety, data management, biostatistics, and clinical pharmacology to meet timelines for safety monitoring committee meetings, regulatory documents and internal reviews to support timely program decisions regarding study objectives
- Support the Clinical Scientist and/or Study Physician in the selection and implementation of biomarker analyses in clinical studies
- Support communication of clinical data in external communications, including scientific publications and presentations
- Contribute to the preparation of regulatory documents, incorporating clinical data as needed
- Work with biostatistics and statistical programming to review key outputs pertaining to data analysis, including statistical analysis plans, table-listing-figure shells, and dry-run outputs
- Collaborate with clinical operations, data management, biostatistics, statistical programming and other applicable team members to identify data issues and queries and assist with data cleaning
- Work with bioanalytics, clinical pharmacology and other applicable team members to support ongoing review and monitoring of clinical laboratory data
- Participate on cross-functional program and study teams as appropriate
- Conduct literature reviews, as needed, and bring findings to the broader team
Key Qualifications
To succeed in this role, the candidate must have strong communication skills and proficiency in understanding, analyzing, and presenting scientific data. The candidate will be able to work as part of a cross-functional team and coordinate tasks for multiple deliverables across multiple studies. Proficiency with Microsoft Excel, PowerPoint and Word are required; experience with Graphpad Prism is strongly preferred.
- Bachelor's degree in life sciences or health-related field with an advanced degree such as a Masters, PharmD, PhD in biological / pharmaceutical science, or MD/DO
- A minimum of 3 to 5 years of research and/or clinical development, or related experience within the industry (pharmaceutical, biotech, CRO, etc.)
- High-performing and energetic individual who demonstrates outstanding scientific knowledge applicable to early disease clinical research and the highest personal and ethical standards
- Must be equally comfortable among the team to which he/she is assigned and in the global environment in which the company operates
- Experience in reviewing, analyzing, and preparing presentations of scientific and/or clinical data in an industry setting required
- Proven ability to work collaboratively in a matrixed-team paradigm required
- Experience in rare diseases preferred
- Significant experience with clinical evaluation projects including development of protocols, case report forms, informed consent and study initiation and monitoring preferred
- Experience with biostatistics, GCP, data integrity, exploration, analysis, regulatory requirements for clinical studies and data presentation preferred
- Ability to work on multiple projects simultaneously required
- Outstanding oral and written communication and presentation skills required
- Ability to be in the Keros office at least 2-3 times per week required
- Ability to travel up to 15% required
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.