{"id":3198656,"url":"https://alion.io/job/alkermes-director-clinical-operations","title":"Director, Clinical Operations","company":{"id":1780712,"name":"Alkermes","domain":"alkermes.com","url":"https://alion.io/company/alkermes","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Oracle","truth_index":{"grade":"B","score":75,"open_postings":8,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-25T05:49:26Z"}},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Waltham, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":219000,"max":235000,"currency":"USD","period":"year","gross":null,"usd_annual":235000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Matter","optional":true}],"status":"live","first_seen_at":"2026-09-10T13:52:53Z","employer_posted_date":"2026-09-10","last_verified_at":"2026-10-25T10:44:47Z","board_verified":true,"closed_at":null,"days_open":45,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":45},"description":"The Director of Clinical Operations in the Discovery Medicine and Pharmaceutical Sciences plays a central role in the execution of Phase 1 clinical studies conducted in healthy volunteers at Alkermes. This role provides operational leadership for healthy volunteer studies across the clinical development lifecycle, ensuring studies are conducted in compliance with GCP, FDA regulations, ICH guidelines, company SOPs, and project timelines.\nThe Director will partner closely with Clinical Pharmacology, Translational Medicine, Medical, Biometrics, Regulatory Affairs, Clinical Supply, Quality Assurance, Pharmacovigilance, and CRO partners to ensure successful execution of first-in-human (FIH), SAD, MAD, food effect, relative bioavailability, DDI, QTc, and other early development studies in healthy volunteers.\nThe successful candidate will be responsible for study budgets, forecasting, resource planning, operational strategy, inspection readiness, eTMF oversight, vendor management, and continuous process improvement and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.\nAlkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work. \n Lead planning, execution, and delivery of Phase 1 clinical studies, including FIH, SAD/MAD, food effect, BA/BE, HAP, TQT, DDI, and other studies in healthy volunteers.\n\nDevelop and manage study timelines, budgets, forecasts, and resource plans to ensure on-time and on-budget delivery.\n\nProvide operational input into protocol development, study design, feasibility assessments, and risk mitigation strategies.\n\nOversee CROs, Phase 1 units, laboratories, and clinical vendors, ensuring quality, performance, and adherence to study objectives.\n\nEnsure compliance with FDA regulations, ICH-GCP guidelines, company SOPs, and applicable global regulatory requirements.\n\nPartner with Clinical Pharmacology, Translational Medicine, Regulatory Affairs, Biostatistics, Medical, Safety, and Clinical Supply teams to support study execution and development objectives.\n\nMaintain inspection readiness and oversee eTMF quality, completeness, and timely document filing throughout the study lifecycle.\n\nMonitor study progress, enrollment, safety, data quality, and operational metrics, proactively addressing risks and issues.\n\nSupport IND submissions, protocol amendments, regulatory inspections, audit readiness, study closeout, and CSR activities.\n\nParticipate in SOP development, process mapping, and other departmental activities.\n\nLead, mentor, and develop Clinical Operations staff while driving operational excellence, process improvements, and a culture of quality and accountability.\n\n Basic Qualifications:\nB.S, M.S or Ph.D in basic sciences with 12+ years of Clinical Operations experience at biotechnology or pharmaceutical company or CRO\nMinimum of 5 yrs managing Phase 1 Studies in healthy volunteers\n\nPreferred Qualifications:\nPrior people management experience preferred.\n\nExpertise in Subject Matter and competent in application of standard business procedures (SOPs, ICH, Global Regulations, Ethics and Compliance)\nThe annual base salary for this position ranges from $219,000 to $235,000. In addition, this position is eligible for an annual performance pay bonus. Exact compensation may vary based on skills, training, knowledge, and experience. Alkermes offers a competitive benefits package. Additional details can be found on our careers website: www.alkermes.com/careers#working-here","description_format":"text","description_chars":3845,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":5,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Hybrid work"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Biologics & Biosimilars","Psychiatric Care"],"lifecycle":[{"event":"open","at":"2026-10-24T06:46:48Z"}],"visa":[],"liveness":{"score":27,"band":"fade","label":"Fading","p_open":1,"p_active":0.786,"p_room":0.35,"age_days":44,"expected_fill_days":22,"reasons":["conf:8","win:tail"],"computed_at":"2026-10-25T05:49:26Z"},"pay":{"stated_usd_annual":235000,"is_top_pay":false},"html_url":"https://alion.io/job/alkermes-director-clinical-operations","json_url":"https://alion.io/job/alkermes-director-clinical-operations.json","meta":{"generated_at":"2026-10-25T15:16:00Z","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":21996,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-26T00:00:00Z"}},"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":1780712},"rest":"https://alion.io/mcp/rest/get_company?id=1780712"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Falkermes-director-clinical-operations"},{"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%2Falkermes-director-clinical-operations"},{"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%2Falkermes-director-clinical-operations"},{"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/alkermes-director-clinical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Falkermes-director-clinical-operations"}]}