Job: Clinical Research Scientist, Lyra Therapeutics, Inc., Watertown, MA

General Information

Job title:
Clinical Research Scientist
Job location:
Watertown, MA 02472 United States

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Job Description

Lyra Therapeutics (Nasdaq: LYRA) is a clinical-stage company pioneering a new therapeutic approach to treat debilitating ear, nose and throat (ENT) diseases that impact the lives of millions of people. Our goal is to transform the ENT treatment paradigm by providing effective front-line solutions for physicians and new treatment options for their patients. In a Phase 1 study, the company observed a rapid, clinically meaningful and durable improvement in symptom score, with 90% of Chronic Rhinosinusitis (CRS) patients having improved symptoms at 24 weeks. A positive Phase 2 study readout of LYR-210 for the treatment of chronic rhinosinusitis with and without nasal polypsis was recently announced and LYR-220 is expected in the clinic next year. Headquartered in the Boston area, Lyra Therapeutics was founded by George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science and biotechnology.

Our team is growing, and we are currently seeking a Clinical Research Scientist, to join our Clinical Affairs team. Reporting to the Associate Director, Clinical Affairs, the Clinical Research Scientist will provide scientific, clinical, and operational input to early and late stage clinical development programs with an emphasis on protocol-specific, in-life clinical data monitoring activities. This role will work on cross-functional study teams for the design, execution, and monitoring of clinical trials, as well as assist with data interpretation and communication. The Clinical Research Scientist may also serve as a point of contact for CROs and clinical sites in day-to-day clinical study needs. This individual may also participate in selected projects in clinical development.

Key Areas of Responsibility:

• Work with a cross-functional team to conduct clinical studies, including clinical and safety data review, site interface on clinical study content, preparation of meeting materials, communication plans (e.g., administrative letters, protocol amendments, protocol deviations), safety and medical monitoring, preparation of status update reports, and study close-out activities

• Support Clinical Operations function with medical monitoring reports, safety reviews, site interactions, and reviewing TFLs

• Responsible for analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendations

• Analyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safety

• Provide clinical operational support for Data Monitoring Committees including operationalizing the charter, preparing updates and blinded data reviews, execution of meetings and adjudications, and communication of synthesized data reports

• Contribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documents under the direction of the manger

• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalations

• Represent Lyra to outside personnel in the development of clinical protocols and study conduct

• Contribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendors

• Prepare literature reviews as needed

• Support preparation of scientific material for conference presentations or publications

• Collaborate with cross-functional groups at Lyra for assigned studies

• Perform other duties as assigned related to clinical programs

Job Requirements

Master's Degree in life sciences with a minimum of 2 years of clinical or pre-clinical research experience in the pharmaceutical industry or healthcare setting; PhD preferred

• Experience in analysis and interpretation of clinical data (safety and efficacy); working knowledge of biostatistics, GCP, and regulatory requirements for clinical studies; global clinical research experience and experience working with clinical trial sites preferred

• Ability to make independent, timely and appropriate decisions

• Excellent oral and written communication skills and solid computer/analytical skills

• Ability to work collaboratively in a fast-paced, team-based matrix environment and to function independently as appropriate

• Exceptional organizational and project management skills with the ability to handle multiple projects at a time

• Strong detail orientation with ability to understand the higher-level strategy

• Ability to think creatively and innovatively with flexibility to accommodate changes in team and project needs

• Experience in all stages of drug development preferred

At Lyra, we value creativity, leadership, and collaboration. The company sees significant expansion opportunities for our platform, and look for people who are driven to succeed, innovative, and adaptable. We offer a competitive compensation and benefit package with opportunities to join a fast-paced, high performing team. For consideration, please submit cover letter and CV.

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(Job number: 4036730)