{"id":3121028,"url":"https://alion.io/job/metaphore-sr-director-clinical-operations","title":"Sr. Director, Clinical Operations","company":{"id":3780300,"name":"Metaphore","domain":"metaphorebio.com","url":"https://alion.io/company/metaphorebio","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"explicit","locations":["Somerville, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":213000,"max":280000,"currency":"USD","period":"year","gross":null,"usd_annual":280000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-09-24T15:30:51Z","employer_posted_date":"2026-10-06","last_verified_at":"2026-11-14T00:15:32Z","board_verified":true,"closed_at":null,"days_open":50,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":50},"description":"Company Summary\nMetaphore Biotechnologies, Inc. is a privately held biotechnology company building the next generation of biological therapeutics. Inspired by nature, our mission is to transform patient lives by unlocking the power of biological therapeutics with a new proprietary discovery platform. Metaphore’s platform brings together live-cell experimentation and AI/ML to understand how biological mechanisms drive functional outcomes in living systems. By capturing these mechanism-function relationships, Metaphore aims to design antibody medicines with intended activity from the start.\nPosition Summary\nMetaphore Biotechnologies is seeking a Senior Director of Clinical Operations to lead the hands-on execution of early clinical development activities for the company’s first-in-human program. Reporting to the Chief Medical Officer, this is a senior individual-contributor role with broad ownership and visibility across the organization.\nThis individual will own clinical operational planning and study execution encompassing CROs and vendor management, site strategy, protocol feasibility, regulatory coordination, and global study start-up, with particular focus on Phase 1 readiness and execution. The successful candidate will be highly operational, able to ramp quickly, and comfortable establishing fit-for-purpose capabilities while working across internal teams, external partners, and consultants to move studies forward with urgency and rigor.\nKey Responsibilities\nLead clinical operations planning and execution for early development programs, with primary accountability for first-in-human study readiness, global start-up, and delivery against key milestones.\nDevelop and maintain integrated study plans, timelines, budgets, forecasts, resource requirements, and risk-mitigation strategies aligned with clinical and corporate objectives.\nLead CRO and vendor selection and oversight, including requests for proposals, bid evaluations, scope-of-work development, budget negotiations, change-order management, performance monitoring, and issue escalation.\nPartner with Clinical Development and Medical leadership to evaluate protocols, study designs, operational feasibility, and start-up requirements.\nRepresent Clinical Operations on cross-functional study and program teams, partnering with other relevant functions internally and externally (e.g., Clinical Development, Regulatory, Safety, Clinical Pharmacology, Data Management, Biostatistics, Bioanalytical, CMC, Quality, and clinical supply colleagues).\nDevelop and execute the Phase 1 site strategy, including the identification, qualification, activation, and ongoing management of sites with appropriate participant access, clinical pharmacology capabilities, bioanalytical infrastructure, and operational experience.\nLead global clinical operations activities across the U.S., Europe, Australia, and other ex-U.S. regions, accounting for applicable regulatory, ethics, site, laboratory, vendor, and country-specific start-up requirements.\nContribute to operational planning for potential studies in China and coordinate with internal and external experts to support regional requirements.\nEstablish an effective operating cadence with CROs, sites, vendors, consultants, and functional partners to track deliverables, timelines, budgets, quality metrics, risks, and escalation paths.\nOversee the development and maintenance of study-level operational documentation, including monitoring, communication, enrollment, vendor-oversight, and risk-management plans.\nPartner with CMC and clinical supply stakeholders to support investigational product packaging, labeling, distribution, accountability, and site readiness.\nEnsure clinical studies are conducted in accordance with the protocol, ICH-GCP, applicable regulatory requirements, internal procedures, and established quality standards.\nMaintain inspection-ready clinical trial documentation and oversee the completeness, quality, and timeliness of the Trial Master File.\nIdentify operational risks early and implement mitigation and contingency plans related to timelines, sites, enrollment, vendors, clinical supply, and data delivery.\nEstablish scalable, fit-for-purpose clinical operations processes, systems, SOPs, and governance practices appropriate for a growing biotechnology company.\nProvide clear and timely updates on study status, timelines, budgets, risks, and mitigation plans to the CMO, clinical leadership, and other key stakeholders.\nRequired Qualifications\nBS/MS/PhD degree in a scientific, healthcare, or related discipline; an advanced degree is preferred.\n10+ years of progressive clinical operations experience in the biotechnology or pharmaceutical industry.\nDirect experience leading first-in-human or Phase 1 studies from operational planning and vendor selection through regulatory and ethics submissions, site activation, first-participant-in, and ongoing execution.\nStrong working knowledge of CRO and vendor selection and oversight, site strategy, global study start-up, and operational planning.\nDemonstrated experience managing study budgets, vendor contracts, scopes of work, change orders, timelines, and forecasts.\nExperience reviewing clinical protocols and translating study designs into executable operational plans.\nExperience supporting clinical pharmacology/DMPK, including dose-escalation, SAD/MAD, biomarker, or other early-phase study designs, as applicable.\nExperience conducting studies involving [healthy volunteers/specific patient population-to be completed based on the planned first-in-human study].\nBroad understanding of FDA, EU, and other ex-U.S. clinical trial requirements.\nStrong knowledge of ICH-GCP, sponsor oversight responsibilities, TMF requirements, clinical quality standards, and inspection readiness.\nAbility to operate independently and influence without direct authority in a fast-paced environment with limited infrastructure and high levels of ambiguity.\nStrong communication and cross-functional collaboration skills, with the ability to manage internal stakeholders, external vendors, and consultants effectively.\nAbility and willingness to travel domestically and internationally, as needed.\nPreferred Qualifications\nExperience in both biotechnology and pharmaceutical company environments, with exposure to the broader clinical development lifecycle.\nDirect experience initiating and executing early-phase studies in Australia, including familiarity with local regulatory, ethics, site, and vendor pathways.\nExperience with China regulatory and clinical operations pathways.\nExperience in antibody therapeutics, biologics, or other advanced therapeutic development programs.\nExperience operationalizing biomarker, immunogenicity, pharmacokinetic, pharmacodynamic, or other specialized sample-collection and bioanalytical strategies within early-phase studies.\nExperience establishing clinical operations infrastructure, processes, systems, and external partnerships within an organization entering the clinic for the first time.\nValues and Behaviors\nWe are seeking individuals with an entrepreneurial spirit, strong communication skills, and comfort working in and contributing to a dynamic and cross-functional team environment. The level of the role will be commensurate with the education and years of experience of the identified candidate.\nAt Flagship, we recognize there is no perfect candidate. If you have some of the experience listed above but not all, please apply anyway. Experience comes in many forms, skills are transferable, and passion goes a long way. We are dedicated to building diverse and inclusive teams and look forward to learning more about your unique background.\nRecruitment & Staffing Agencies: Flagship Pioneering and its affiliated Flagship Lab companies (collectively, “FSP”) do not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to FSP or its employees is strictly prohibited unless contacted directly by Flagship Pioneering’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of FSP, and FSP will not owe any referral or other fees with respect thereto.\nThe salary range for this role is $213,000 - $280,000. Compensation for the role will depend on a number of factors, including a candidate’s qualifications, skills, competencies, and experience. Metaphore Biotechnologies, Inc. currently offers healthcare coverage, annual incentive program, retirement benefits and a broad range of other benefits. Compensation and benefits information is based on Metaphore Biotechnologies, Inc.'s good faith estimate as of the date of publication and may be modified in the future.\nPrivacy Notice for Applicants: When you apply for a role at Metaphore Biotechnologies, Inc., a Flagship Pioneering portfolio company, we collect and use personal information you provide (such as your name, contact details, work history, and application materials) to evaluate your application, communicate with you, and comply with legal obligations. Your application data is processed through Greenhouse, our applicant tracking system, and may also be reviewed using AI-assisted screening tools. We do not sell your personal information. California residents have rights under the CCPA/CPRA including to know, delete, and opt out of the sharing of their personal information. If you are located in the EU or UK, we process your data under GDPR and you have rights to access, rectify, and erase your data. To exercise your rights or for questions, contact .","description_format":"text","description_chars":9688,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United Kingdom","iso":"GB","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["CRO & CDMO Services","Immunology & Inflammation Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-23T00:24:45Z"}],"visa":[],"liveness":{"score":30,"band":"fade","label":"Fading","p_open":1,"p_active":0.666,"p_room":0.45,"age_days":48,"expected_fill_days":29,"reasons":["conf:0","win:tail"],"computed_at":"2026-11-12T10:38:37Z"},"pay":{"stated_usd_annual":280000,"is_top_pay":false},"html_url":"https://alion.io/job/metaphore-sr-director-clinical-operations","json_url":"https://alion.io/job/metaphore-sr-director-clinical-operations.json","meta":{"generated_at":"2026-11-14T04:43:16Z","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":7712,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-15T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.1,"usd":0.01,"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":3780300},"rest":"https://alion.io/mcp/rest/get_company?id=3780300"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fmetaphore-sr-director-clinical-operations"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"free","price":{"credits":0,"usd":0},"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%2Fmetaphore-sr-director-clinical-operations"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.1,"usd":0.01},"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%2Fmetaphore-sr-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/metaphore-sr-director-clinical-operations\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fmetaphore-sr-director-clinical-operations"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3121028}},{"tool":"search_jobs","arguments":{"company":"metaphorebio.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3121028},"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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