{"id":3068046,"url":"https://alion.io/job/certara-senior-director-clinical-operations","title":"Senior Director, Clinical Operations","company":{"id":1834324,"name":"Certara","domain":"certara.com","url":"https://alion.io/company/certara","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"iCIMS","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":183000,"max_usd":315000,"period":"year","method":"global_role_seniority_cell","sample_n":507},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":true},{"name":"Outlook","optional":true},{"name":"SharePoint","optional":true}],"status":"live","first_seen_at":"2026-10-22T05:58:42Z","employer_posted_date":null,"last_verified_at":"2026-10-22T05:58:42Z","board_verified":false,"closed_at":null,"days_open":14,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":14},"description":"Overview\n\nAbout Certara\nCertara accelerates the potential of bringing medicines to market and to patients using biosimulation software, technology, and services to transform traditional drug discovery and development. Our clients include more than 2,400 biopharmaceutical companies, academic institutions, and regulatory agencies across 70 countries.\nOur goal is to enable the life sciences industry’s use of data, modeling, and analytics to make better decisions across the various phases of discovery and drug development. Our software and scientists incorporate modern advances in scientific understanding, drug development experience, data analysis, and AI resulting in significant opportunities to decrease the cost and increase the probability of success for new drug approval and commercialization.\nThe Senior Director for clinical operations will provide leadership for strategic projects by ensuring that there is strong alignment between strategy, goals, and implementation. May or may not have direct reports.\n\nResponsibilities\n\nLeads Certara Clinical Operations and Study Management activities.\n\nLeads CRO/vendor selection process for outsourced activities, including development of scope of services agreements, budgets, plans and detailed timelines.\n\nWorks with Certara team and sponsors to select CROs, train investigators and investigative site staff, preparation of materials for investigator meetings, and clinical supplies as applicable.\n\nWork with Certara QA to review CRO Quality Systems and perform audits as required.\n\nParticipate and prepare for regulatory and/ or client audits when scheduled.\n\nLeads (or is a member of) Certara's study management team (SMT).\n\nDrives (or supports SMT lead) in the development and review of study planning to meet client objectives (including timelines, metrics, and budgets).\n\nResponsible for providing sponsor oversight of Phase 1 clinical study conduct (start-up through database lock and reporting), including review of study documents and coordinating cross-functional efforts to achieve study objectives and goals with a focus on quality.\n\nEnsure sponsor and CRO aspects of clinical studies run by Certara on behalf of clients are conducted in compliance with SOPs, Agency regulations, ICH/GCP guidelines and applicable local laws.\n\nProvide oversight of activities associated with the implementation, management and oversight of clinical trials.\n\nProvides training to internal and external customers as needed.\n\nParticipate and provide expert clinical operations input into the writing of key clinical study documents including protocols and amendments, Informed Consent Forms, Investigator Brochures (IB) and Investigational New Drug Applications (INDs), providing guidance on operational and logistical issues.\n\nIdentifies and communicates in a timely manner study issues that will impact budget, resources and timelines.\n\nReviews and critiques case report forms/eCRFs for accuracy and completeness.\n\nOversees data discrepancy management and assists with mapping as needed.\n\nManages all aspects of vendor relationships to achieve project goals and ensure that performance expectations are met.\n\nManages vendor agreements, change orders and site budgets to meet clinical operations specifications.\n\nResponsible for review of invoices for accuracy compared to work known to be performed by the vendor.\n\nEnsures that supportive study documents are completed with a focus on quality.\n\nAssist in the preparation of clinical study reports.\n\nIn collaboration with QA, develop clinical operations quality systems, including standard operating procedures, document management, clinical operations personnel training, and quality control processes.\n\nContributes to wider organizational goals and/or activities as assigned.\n\nCommunication\nCollaborate directly with sponsors and stakeholders in developing business requirements, business controls and implementation plans.\n\nCommunicate issues, issue status, and issue resolution on a regular basis to appropriate team members.\n\nProvide leadership and timely feedback to keep all stakeholders, including senior management, informed of project progress.\n\nQualifications\n\nBachelor's degree required; science base education preferred; minimum of fifteen years related experience in the CRO, pharmaceutical or biotechnology industry, including at least 5 years of early development, Phase I CPU experience preferable.\n\nPrevious experience managing direct reports is a plus.\n\nSelf-starter with expertise in Phase 1 drug development, operations, and strategic planning.\n\nEffective leadership skills and ability to foster team productivity and cohesiveness.\n\nExperience leading multi-disciplinary teams and mentoring clinical team members.\n\nKnowledge of clinical pharmaceutical standards, ICH/GCP guidelines, and regulatory compliance.\n\nKnowledge of Clinical Trial Regulatory requirements in USA and EMA (Australia a bonus).\n\nExperience managing Clinical Trial Supply in collaboration with manufacturer and CRO.\n\nExperience developing or reviewing SOPs.\n\nExperience managing CROs, central laboratories, and other clinical vendors.\n\nExperience managing contracts (vendor and site) and finance activities.\n\nKnowledge of data management, data review/analysis, and pharmacovigilance requirements.\n\nFamiliarity with project planning tools and task dependencies.\n\nSkills & Abilities\nAbility to prioritize and manage multiple concurrent tasks in a fast-paced deadline driven environment while delivering high quality results.\n\nAbility to write clearly and summarize information effectively.\n\nAbility to solve complex problems and manage multiple tasks simultaneously.\n\nStrong communication and interpersonal skills.\n\nSelf-motivated with strong attention to detail and analytical problem-solving skills.\n\nProficiency in MS Office (Outlook, Word, Excel, PowerPoint, MS Project, Teams) and SharePoint.\n\nCertara bases all employment-related decision on merit, taking into consideration qualifications, skills, achievement, and performance. We treat all applicants and employees without regard to personal characteristics such as race, color, ethnicity, religion, sex, sexual orientation, age, nationality, marital status, pregnancy, physical or mental condition, genetic information, military service, or other characteristic protected by law.\nOriginally posted on Himalayas","description_format":"text","description_chars":6359,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care","Bioinformatics","Drug Discovery","CRO & CDMO Services"],"lifecycle":[{"event":"open","at":"2026-10-22T08:29:45Z"}],"visa":[],"liveness":{"score":77,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.859,"p_room":0.9,"age_days":13,"expected_fill_days":30,"reasons":["seen:13","velocity","win:mid"],"computed_at":"2026-11-05T05:54:30Z"},"pay":null,"html_url":"https://alion.io/job/certara-senior-director-clinical-operations","json_url":"https://alion.io/job/certara-senior-director-clinical-operations.json","meta":{"generated_at":"2026-11-05T12:06:11Z","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":15550,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":1834324},"rest":"https://alion.io/mcp/rest/get_company?id=1834324"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcertara-senior-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%2Fcertara-senior-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%2Fcertara-senior-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/certara-senior-director-clinical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcertara-senior-director-clinical-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3068046}},{"tool":"search_jobs","arguments":{"company":"certara.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3068046},"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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