Clinical Project Manager/ Senior Clinical Project ...

Perceive Biotherapeutics is an exciting clinical-stage company (lead program in Phase 2), focusedon improving human health by developing breakthrough neuroprotective therapeutics inophthalmology that use novel approaches to treat highly prevalent, blinding diseases thatcurrently have no good therapeutic alternatives. Perceive brings together an experienced, worldclassteam of leaders, scientists and drug developers. Our unique approach is a first-in-class andbest-in-class gene therapy that will significantly impact patients’ lives. Our team is mission driven,expert, agile and pragmatic.We are looking for a talented and experienced individual to join our growing Clinical Operationsteam and contribute to the company’s long-term goals and success. The successful candidate willbe diversely experienced, thoughtful, collaborative, highly motivated & productive, and possessthe desire to learn, improve processes, and support key clinical stakeholders during our Ph 1 andPh 2 trials with an emphasis towards quality, efficiency and operational best practices.Context and Job Duties/Responsibilities:This role is intended to ensure end-to-end clinical management, including trial set-up,enrollment, execution and cross-functional coordination with multiple clinical trial sites andvendors in global Ph 1 and Ph 2 trials, per established timelines. The CPM will be responsible forsite, CRO and trial vendor management to ensure timely and high-quality clinical trial conduct,maintaining strong relationships between service providers and clinical trial sites, and for keepingmanagement apprised of clinical progress against established milestones.This individual will help to set the standards for clinical operations performance and build thewider culture of accountability, collaboration and continuous improvement. A successfulcandidate in this role will quickly determine and address needs along these lines:Manage defined aspects of clinical trials to ensure trials are completed on time and incompliance with Code of Federal Regulations (CFR), ICH/GCP guidelines and company SOPs.Plan, coordinate and manage activities within various phases of clinical studies (i.e. studyplanning, site qualification and selection, study start-up, enrollment, monitoring, datareview and cleaning, closeout, etc.).Contribute in development of essential study documents and develop, review/approvestudy specific operational documents, tools and trackerProvide Vendor Management and Oversight (participate in selection, qualification,contracting of clinical vendors, coordinate and/or lead vendor set-up and managementactivities)Build and maintain great working relationships with KOLs and PIs and extended site staff atclinical sites and participate in site interactions and management from identificationthrough closeout.Drive cross-functional collaboration with internal stakeholders to support timely andaligned trial execution.Contribute to departmental process improvement initiatives and support the growth andmentorship of junior team members, where applicable.Travel: Up to 20% travel may be requested for site engagement and internal meetings. Thesemay include multi-day international trips. Position is remote Pacific Time zone work hours isstrongly preferred.Education, Experience, Capabilities and Knowledge:A successful candidate for this role is an expert in all aspects of pharmaceutical clinical researchand the requirements of the clinical operations function. The successful candidate alsothoroughly understands early, mid and late-stage trial performance, forecasting, staffing, andbusiness operations. Qualifications include:Bachelor of Science degree required with a focus in a biomedical or related clinical fieldstrongly preferred; advanced degree also preferred.3+ years of experience in clinical operations, with at least 2 years of direct clinical trialmanagement experience at a sponsor or CRO required.At least 5 years of experience in the clinical research / pharmaceutical / biotech /medical device industries.Experience with retina/ophthalmology and gene therapy strongly preferred.Experience in a small, innovative company environment preferred.Previous on-site monitoring experience is preferred.Proven ability to drive timelines, quality, and compliance across multiple vendors andTrainings and SkillsThorough knowledge and understanding of FDA and ICH Guidelines, Good ClinicalPractices (GCP), and medical terminology.Demonstrated ability to lead clinical projects to timelines and on budget, includingdetailed tracking, troubleshooting, and effective escalation with excellent planning andorganizational skills.Demonstrated success in working with outside organizations/groups/vendors/CROs.Strong project management skills.Excellent communication, negotiation, and stakeholder management skills.Strong critical thinking, organizational, and problem-solving abilities.Demonstrated trackrecord of success working in remote or hybrid work environments.High personal integrity, strong work ethic, accountability, and a solutions-orientedDemonstrated leadership and team management skills.Demonstrated business acumen with strong understanding of sponsor businessLocationThis is a remote position.Targeted annual pay band is $165,000-195,000 with some flexibility commensurate with experience.Perceive Biotherapeutics provides equal employment opportunities (EEO) to all employees andapplicants for employment without regard to religion, race, creed, color, sex, sexual orientation,alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteranor military status, predisposing genetic characteristics or any other characteristic protected byapplicable federal, state or local law.Please note that Perceive Bio will only collect personal information using a legitimate companyemail domain and will never offer payment or any financial transaction over text or email. Alwaysverify that emails or other communications are directly from perceivebio.com.#LI-DNI

Created: 2025-12-08