{"id":1577620,"url":"https://alion.io/job/immunic-therapeutics-associate-director-clinical-study-lead","title":"Associate Director, Clinical Study Lead","company":{"id":3792695,"name":"Immunic Therapeutics","domain":"imux.com","url":"https://alion.io/company/imux","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Ashby","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":["Boston, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":180000,"max":210000,"currency":"USD","period":"year","gross":null,"usd_annual":210000},"salary_estimate":null,"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-09-08T15:14:16Z","employer_posted_date":"2026-09-08","last_verified_at":"2026-10-22T08:32:46Z","board_verified":true,"closed_at":null,"days_open":43,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":43},"description":"Summary\nWe are seeking a (Regional) Clinical Study Lead at senior manager / associate directorslevel to provide operational leadership for the planning and execution of one or more clinical studies, with direct accountability for assigned regions, countries, and delegated study activities. You will serve as the principal clinical operations contact for the assigned scope, coordinating cross-functional teams, investigative sites, CROs, and specialist vendors to deliver studies safely, on time, within budget, and in compliance with the protocol, ICH-GCP, applicable regulations, and company procedures. The ideal candidate combines strong end-to-end clinical study management experience with effective CRO oversight, disciplined risk management, and the ability to lead through influence in a global matrix environment.\nResponsibilities\nProvide operational leadership for the planning, start-up, conduct, maintenance, and close-out of assigned global studies or regions, ensuring delivery against approved scope, timelines, quality standards, and budget.\nServe as the principal Clinical Operations representative on cross-functional study teams and associated sub-teams, clearly communicating operational status, risks, assumptions, dependencies, and recommendations.\nDevelop, review, and maintain integrated study execution plans, regional and country strategies, enrollment plans, oversight plans, monitoring plans, study manuals, and operational trackers.\nContribute operational input to protocols, informed consent forms, eCRFs, investigator materials, clinical study reports, and other critical study documents.\nLead or oversee country and site feasibility, site identification, qualification, selection, activation, training, enrollment, maintenance, and close-out activities for the assigned scope.\nContribute to CRO and vendor selection and oversight activities, including scope definition, contracting support, performance expectations, governance, issue resolution, change control, invoice review, and reconciliation.\nMonitor study and vendor performance through meaningful KPIs, quality indicators, milestones, forecasts, and dashboards; implement corrective actions and escalate material issues in a timely manner.\nIdentify operational, quality, timeline, budget, and compliance risks; maintain mitigation plans and coordinate resolution with the Global Clinical Study Lead and cross-functional stakeholders.\nProvide accurate inputs to study timelines, budgets, accruals, resource forecasts, enrollment forecasts, clinical supply forecasts, and scenario planning activities.\nCoordinate regional or country-level investigator meetings, site communications, training, and engagement activities in partnership with relevant internal and external stakeholders.\nEnsure sponsor oversight activities are documented and inspection-ready, including appropriate management of the eTMF, essential documents, monitoring deliverables, deviations, CAPAs, and study correspondence.\nEnsure timely completion of database-lock readiness, document reconciliation, site and vendor closure, final payments, archiving, and delivery of Clinical Operations content for the clinical study report and appendices.\nSupport audits, inspections, and health-authority interactions by providing complete, accurate, and traceable operational documentation and responses.\nProvide technical guidance, coaching, and mentoring to junior Clinical Operations team members and contribute to departmental standards, tools, and process improvements.\nAct as back-up for the Global Clinical Study Lead or other study leadership roles as assigned\nQualifications & Experience\nBachelor's degree or higher in nursing, life sciences, health sciences, or a related discipline; an equivalent combination of education and relevant clinical research experience may be considered.\nTypically 7+ years of pharmaceutical, biotechnology, or CRO experience, including at least 6 years of clinical research experience with increasing responsibility.\nDemonstrated experience managing Phase 1-3 clinical studies or substantial regional components from start-up through close-out and clinical study report delivery.\nExperience working in a fully or substantially outsourced operating model, including selection, contracting, oversight, and performance management of CROs and specialist vendors.\nStrong working knowledge of ICH-GCP, applicable FDA, EMA, and local regulatory requirements, sponsor oversight expectations, inspection readiness, and clinical quality management principles.\nProven ability to manage complex timelines, budgets, risks, priorities, and cross-functional dependencies in a global matrix organization.\nStrong analytical, organizational, and problem-solving skills, with consistent attention to detail and a proactive, accountable working style.\nExcellent written and verbal communication skills in English, with the ability to influence internal and external stakeholders across cultures and levels of seniority.\nAbility to work effectively and independently in a dynamic, flexible, and innovative environment while managing multiple responsibilities under pressure.\nWillingness and ability to travel domestically and internationally based on study needs.\nImmunic Therapeutics is an Equal Opportunity Employer. We are committed to fostering a diverse, inclusive, and equitable workplace where all individuals are valued and respected. Employment decisions are based on qualifications, merit, and business needs, without regard to race, color, religion, gender, sexual orientation, national origin, disability, veteran status, or any other protected status.\nPlease note, Immunic does not accept unsolicited resumes from external agencies or recruiters. Submission of a resume without a prior written agreement does not create any express or implied contract between Immunic and the agency. Immunic will not pay any fees related to unsolicited resumes.","description_format":"text","description_chars":5926,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"},{"name":"Boston","iso":null,"kind":"city"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-01T10:55:36Z"}],"visa":[],"liveness":{"score":39,"band":"fade","label":"Fading","p_open":1,"p_active":0.703,"p_room":0.55,"age_days":43,"expected_fill_days":30,"reasons":["conf:1","win:tail"],"computed_at":"2026-10-22T06:10:10Z"},"pay":{"stated_usd_annual":210000,"is_top_pay":false},"html_url":"https://alion.io/job/immunic-therapeutics-associate-director-clinical-study-lead","json_url":"https://alion.io/job/immunic-therapeutics-associate-director-clinical-study-lead.json","meta":{"generated_at":"2026-10-22T10:57:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":8496,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-23T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":3792695},"rest":"https://alion.io/mcp/rest/get_company?id=3792695"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fimmunic-therapeutics-associate-director-clinical-study-lead"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fimmunic-therapeutics-associate-director-clinical-study-lead"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fimmunic-therapeutics-associate-director-clinical-study-lead"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/immunic-therapeutics-associate-director-clinical-study-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fimmunic-therapeutics-associate-director-clinical-study-lead"}]}