Director, Clinical Sciences
: Job Details :

DescriptionLyra Therapeutics (Nasdaq: LYRA) is a late clinical stage company developing medicines precisely designed to target ear, nose, and throat (ENT) diseases. Our goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and new treatment options for their patients. Our initial product candidates, LYR-210 and LYR-220, are bioresorbable polymeric matrices designed to be administered in a brief, non-invasive, in-office procedure and intended to deliver up to six months of continuous drug therapy to the sinonasal passages for the treatment of chronic rhinosinusitis, or CRS. Headquartered in the Boston area, Lyra Therapeutics was foundedby George Whitesides and Robert Langer, academic luminaries in the fields of chemistry, materials science, and biotechnology.Lyra Therapeutics is growing, and we are seeking a highly skilled and experienced Director/Sr. Director of Clinical Sciences, to join our dynamic Clinical Development team. Reporting to the Senior Vice President, Clinical Affairs, the Director of Clinical Sciences will play a crucial role in driving scientific, clinical, and operational strategy to late stage clinical development. This role will lead cross-functional study teams for the study design, data interpretation, and communication. The successful candidate will have a strong background in clinical research, a deep understanding of regulatory requirements, and the ability to lead cross-functional teams.Responsibilities:Develop and implement the clinical development strategy for Lyra's productsWork closely with the Clinical executive team to align clinical programs with overall business objectivesDesign and oversee the execution of clinical trials, ensuring compliance with regulatory standards and guidelinesWork 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 activitiesManage a Clinical ScientistFoster collaboration and communication among internal and external team members to drive successful clinical development milestonesProvide scientific and medical expertise to guide clinical development programsWork closely with medical monitors and key opinion leaders to ensure the scientific integrity of clinical trialsSupport Clinical Operations function with medical monitoring reports, safety reviews, site interactions, and reviewing TFLsProvide analytical support of clinical trial data (safety and efficacy), including gathering, analyzing, reviewing, interpreting, and providing preliminary assessments and recommendationsAnalyze and synthesize information to assess issues relating to protocol conduct and/or individual subject safetyProvide 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 reportsContribute to protocols, clinical study reports, IBs, ICFs, training documents, and other clinical and regulatory documentsInteract with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical trial objectives; responds to or triages questions for appropriate escalationsContribute to the organization, preparation, and execution of investigator and advisory board meetings in collaboration with the project team and external vendorsPrepare literature reviewsSupport preparation of scientific material for conference presentations and publicationsManage the budget for clinical development activitiesOptimize the allocation of resources to meet project timelines and goals RequirementsAdvanced degree in life sciences (MD, PhD, or equivalent) with at least 10 years of clinical research experience in the pharmaceutical industryExperience 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 preferredExcellent oral and written communication skills and solid analytical skillsAbility to work collaboratively in a fast-paced, team-based matrix environmentExceptional organizational and project management skills with the ability to handle multiple projects at a timeAbility to lead and motivate cross-functional teamsStrategic mindset with the ability to align clinical development with business goals while being detail orientedAbility to think creatively and innovatively with flexibility to accommodate changes in team and project needsExperience in all stages of drug development preferredAt 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.#J-18808-Ljbffr