{"id":128663,"date":"2026-07-02T14:09:28","date_gmt":"2026-07-02T14:09:28","guid":{"rendered":"https:\/\/bhsg.com\/jobs\/job\/5050337_1783001368-director-of-clinical-development-and-regulatory-affairs-st-louis-missouri\/"},"modified":"2026-07-02T17:20:25","modified_gmt":"2026-07-02T17:20:25","slug":"5050337_1783001368-director-of-clinical-development-and-regulatory-affairs-st-louis-missouri","status":"publish","type":"job_listing","link":"https:\/\/bhsg.com\/jobs\/job\/5050337_1783001368-director-of-clinical-development-and-regulatory-affairs-st-louis-missouri\/","title":{"rendered":"Director of Clinical Development and Regulatory Affairs"},"content":{"rendered":"<h4><strong><a id=\"myCustomID\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/5050337_1783001368\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n<p class=\"x_MsoNormal\"><span data-olk-copy-source=\"MessageBody\">We are seeking an experienced <strong>Director of Clinical Development &amp; Regulatory Affairs<\/strong> to lead next-phase study design and execution strategy in preparation for FDA submission. This individual will serve as a key scientific and operational leader, working closely with research partners, CROs, and internal stakeholders to design rigorous studies, manage clinical data, and build a compelling, submission-ready regulatory package. This role offers the potential to grow into a senior executive position as the organization scales. This is a <strong>St. Louis-based role<\/strong>, with a broader team operating remotely; comfort with distributed collaboration is essential.<\/span><\/p>\n<div class=\"x_MsoNormal\" align=\"center\">\n<hr align=\"center\" size=\"2\" width=\"100%\" \/><\/div>\n<p class=\"x_MsoNormal\"><strong>KEY RESPONSIBILITIES<\/strong><\/p>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Design and oversee next-phase clinical studies, including protocol development, endpoint selection, site selection, and patient enrollment strategy<\/li>\n<li class=\"x_MsoNormal\">Lead clinical data assessment activities, including review of safety and efficacy data, adverse event monitoring, and interim analyses<\/li>\n<li class=\"x_MsoNormal\">Serve as the primary liaison with the FDA, managing pre-IND meetings, IND submissions, and ongoing regulatory correspondence<\/li>\n<li class=\"x_MsoNormal\">Build and maintain a clinical development plan aligned with FDA approval pathway requirements<\/li>\n<li class=\"x_MsoNormal\">Collaborate with research teams, clinical investigators, and CROs to ensure protocol compliance and data integrity<\/li>\n<li class=\"x_MsoNormal\">Oversee preparation and review of clinical study reports, INDs, NDAs\/BLAs, and other regulatory submissions<\/li>\n<li class=\"x_MsoNormal\">Identify and manage external CRO and vendor relationships to support trial execution<\/li>\n<li class=\"x_MsoNormal\">Contribute to fundraising and partnering narratives by translating clinical progress into investor- and partner-facing materials<\/li>\n<\/ul>\n<div class=\"x_MsoNormal\" align=\"center\">\n<hr align=\"center\" size=\"2\" width=\"100%\" \/><\/div>\n<p class=\"x_MsoNormal\"><strong>QUALIFICATIONS<\/strong><\/p>\n<p class=\"x_MsoNormal\"><strong>Required<\/strong><\/p>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Degree in a life sciences or clinical discipline preferred<\/li>\n<li class=\"x_MsoNormal\">8+ years of clinical development experience in pharmaceutical, biotech, or clinical research settings<\/li>\n<li class=\"x_MsoNormal\">Demonstrated expertise in clinical trial design, protocol development, and statistical endpoint selection<\/li>\n<li class=\"x_MsoNormal\">Hands-on experience managing clinical data assessment, including safety reviews, efficacy analyses, and data integrity oversight<\/li>\n<li class=\"x_MsoNormal\">Direct experience with FDA regulatory submissions and\/or communications (IND, NDA, BLA, or equivalent)<\/li>\n<li class=\"x_MsoNormal\">Strong working knowledge of GCP, ICH guidelines, and applicable federal regulations<\/li>\n<\/ul>\n<p class=\"x_MsoNormal\"><strong>Preferred<\/strong><\/p>\n<ul type=\"disc\">\n<li class=\"x_MsoNormal\">Prior pharmaceutical or biotech industry experience strongly preferred over pure academic background<\/li>\n<li class=\"x_MsoNormal\">Experience advancing a compound through multiple phases of clinical trials (Phase I through Phase II\/III)<\/li>\n<li class=\"x_MsoNormal\">Familiarity with small company or startup environments; ability to operate effectively without large infrastructure<\/li>\n<li class=\"x_MsoNormal\">Established relationships with academic medical centers and clinical investigators<\/li>\n<li class=\"x_MsoNormal\">Experience with academic-industry research partnerships<\/li>\n<\/ul>\n<div class=\"x_MsoNormal\" align=\"center\">\n<hr align=\"center\" size=\"2\" width=\"100%\" \/><\/div>\n<p class=\"x_MsoNormal\"><strong>COMPENSATION &amp; CULTURE<\/strong><br \/>Offers a competitive compensation package commensurate with experience, including base salary, performance bonus, and equity participation. The team values professionals who thrive in lean, mission-driven environments and want ownership in outcomes.<\/p>\n<p><img decoding=\"async\" src=\"https:\/\/counter.adcourier.com\/cGhhcm1haW5wLjk3NDEyLjEyNTg0QGJlYWNvbmhpbGwuYXBsaXRyYWsuY29t.gif\"><\/p>\n<p><span style=\"color: #ffffff;\">5050337_1783001368<\/span><\/p>\n<h4><strong><a id=\"otherId\" href=\"https:\/\/jobs.beaconhillstaffing.com\/jobs\/job\/5050337_1783001368\">To Apply for this Job Click Here<\/a><\/strong><\/h4>\n","protected":false},"author":0,"featured_media":3770,"template":"","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","inline_featured_image":false,"_promoted":"","_job_location":"St. Louis, Missouri","_application":"pharmainp.97412.12584@beaconhill.aplitrak.com","_company_name":"Beacon Hill Staffing Group","_company_website":"","_company_tagline":"","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job-categories":[233,213],"job-types":[18,2],"class_list":["post-128663","job_listing","type-job_listing","status-publish","has-post-thumbnail","hentry","job-type-direct-permanent","job-type-full-time"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Director of Clinical Development and Regulatory Affairs St. Louis Missouri<\/title>\n<meta name=\"description\" content=\"Director of Clinical Development and Regulatory Affairs St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Director of Clinical Development and Regulatory Affairs job in St. Louis, Missouri\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/bhsg.com\/jobs\/job\/5050337_1783001368-director-of-clinical-development-and-regulatory-affairs-st-louis-missouri\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Director of Clinical Development and Regulatory Affairs St. Louis Missouri\" \/>\n<meta property=\"og:description\" content=\"Director of Clinical Development and Regulatory Affairs St. Louis Missouri - Apply with Beacon Hill Staffing Services for this Director of Clinical Development and Regulatory Affairs job in St. Louis, Missouri\" \/>\n<meta property=\"og:url\" content=\"https:\/\/bhsg.com\/jobs\/job\/5050337_1783001368-director-of-clinical-development-and-regulatory-affairs-st-louis-missouri\/\" \/>\n<meta property=\"og:site_name\" content=\"Nationwide Staffing Agency | Temp &amp; 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