{"id":3462468,"url":"https://alion.io/job/regeneron-pharmaceuticals-manager-clinical-study-lead","title":"Manager, Clinical Study Lead","company":{"id":4267,"name":"Regeneron Pharmaceuticals","domain":"regeneron.com","url":"https://alion.io/company/regeneron","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":78,"open_postings":34,"ghost_share":0,"stale_share":0.882,"repost_share":0,"time_to_fill_p50_days":25,"computed_at":"2026-11-03T05:54:40Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Armonk, United States","Tarrytown, United States","Cambridge, United States","United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":128600,"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":true,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-10-29T14:21:30Z","employer_posted_date":"2026-10-29","last_verified_at":"2026-11-03T07:59:55Z","board_verified":true,"closed_at":null,"days_open":5,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":5},"description":"Build our future together:\nThe Manager, Clinical Study Lead may perform the following responsibilities with moderate oversight: accountable for the global execution of assigned smaller or less complex clinical trials from study design, through execution, to study close out. You are accountable for the study timelines, study budget, and ensuring study conduct is in accordance with Regeneron Standard Operating Procedures (SOPs) and ICH/GCP. This role applies to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and the balance of direct leadership versus oversight will vary accordingly. Contributes and drives ongoing process improvement initiatives.\nWhen & where:\nWork Location: Armonk, NY, Warren, NJ, Cambridge, MA\nTravel Percentage: 25% travel may be required\nDiscover your role:\nLeads the cross-functional study team responsible for clinical study delivery, serving as the primary point of contact for leadership and oversight, and oversees execution against planned timelines, deliverables, and budget while raising issues (conduct, quality, timelines, budget) to the Program Operations Lead and stakeholders and implementing corrective actions\nProvides operational input into protocol development; leads feasibility assessments to select relevant regions and countries; oversees or conducts site evaluation and selection; and leads investigator meeting preparation and execution\nOversees and contributes to study documentation, including case report forms, data management plan, monitoring plan, monitoring oversight plan, project-specific training plan, data review plan, statistical analysis plan, and related materials\nOversees set-up and maintenance of study systems (e.g., CTMS, TMF) and ensures compliance with clinical trial registry requirements\nIdentifies outsourcing needs and leads vendor engagement, contracting, and management; ensures CROs and third-party vendors are aligned and delivering per scope of work\nProvides input into baseline budget and timeline development and management; ensures accurate budget management and scope change control for internal and external studies\nLeads study-level risk assessment and mitigation; monitors site activation and monitoring visits and acts on deviations; leads development and oversees implementation of patient recruitment and retention strategies and responds to deviations from plan; and monitors data entry and query resolution against agreed metrics\nManages study close-out activities, including database lock, reconciliation of vendor contracts, budget, TMF, and study drug accountability; contributes to clinical study report writing and review; and facilitates study-level lessons learned\nAssigns tasks to Clinical Study Management staff and supports their deliverables; directly supervises CTM staff (work assignments, performance management, recruitment, professional development, coaching, mentoring, ongoing training and compliance, and study support/oversight); recommends and participates in cross-functional and departmental process improvements; and identifies innovative, globally informed approaches to study execution and continuous improvement of CTM SOPs\nMay be assigned unmasked tasks for studies, which may include but is not limited to, assisting with masked investigational product, set up and management of unmasked trial master file, review of unmasked data in the electronic data capture system, point of contact for IVRS issues, and support oversight of unmasked clinical monitoring\nThis role requires:\nBachelor’s degree and have at least six years of relevant industry experience\nExtensive budget management expertise; a proven ability to build productive study teams and collaborations; and demonstrated vendor management experience\nStrong technical proficiency with trial management systems and Microsoft applications is required, including Project, PowerPoint, Word, Excel, and platforms such as IVRS/IWRS and EDC\nExperience in global clinical trial operations, including developing protocols and key study documents; solid knowledge of ICH/GCP and relevant regulatory guidelines and directives; and effective project management, cross-functional team leadership, and organizational skills\nAbility to understand and implement the operational strategic direction and guidance for respective clinical studies\nDoes this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.\nWhere necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.\nPlease be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.\nAs part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.\nFor jobs in Canada: this posting is for an existing position.\nSalary Range (annually)\n$128,600.00 - $210,000.00","description_format":"text","description_chars":7067,"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":[]},"benefits":["Annual bonuses","Equity","Professional development","Wellness"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Oncology Therapeutics","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-29T14:21:30Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 316 · green card filings: 4","filings_12m":316,"filings_prev_12m":157,"green_card_filings_12m":4,"median_offered_wage_usd":151938,"route":null,"cap_exempt":false,"checked_at":"2026-10-29T16:27:21+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)","US Department of Labor: PERM disclosure data (green cards)"],"filings_for_role_12m":0}],"liveness":{"score":63,"band":"ok","label":"Likely open","p_open":1,"p_active":0.632,"p_room":1,"age_days":4,"expected_fill_days":25,"reasons":["conf:3","stale_co","velocity","win:early","comp:brand"],"computed_at":"2026-11-03T05:54:40Z"},"pay":{"stated_usd_annual":210000,"is_top_pay":true},"html_url":"https://alion.io/job/regeneron-pharmaceuticals-manager-clinical-study-lead","json_url":"https://alion.io/job/regeneron-pharmaceuticals-manager-clinical-study-lead.json","meta":{"generated_at":"2026-11-03T17:34:09Z","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":24530,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-04T00:00:00Z"}},"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":4267},"rest":"https://alion.io/mcp/rest/get_company?id=4267"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fregeneron-pharmaceuticals-manager-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%2Fregeneron-pharmaceuticals-manager-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%2Fregeneron-pharmaceuticals-manager-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/regeneron-pharmaceuticals-manager-clinical-study-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fregeneron-pharmaceuticals-manager-clinical-study-lead"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3462468}},{"tool":"search_jobs","arguments":{"company":"regeneron.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3462468},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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