{"id":3554403,"url":"https://alion.io/job/beam-therapeutics-director-filing-excellence-program-manager","title":"Director, Filing Excellence Program Manager","company":{"id":1884200,"name":"Beam Therapeutics","domain":"beamtx.com","url":"https://alion.io/company/beamtx","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":null},"role":"Management","role_family":"Management","seniority":"head","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cambridge, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":210000,"max":260000,"currency":"USD","period":"year","gross":null,"usd_annual":260000},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Smartsheet","optional":false}],"status":"live","first_seen_at":"2026-10-30T20:00:54Z","employer_posted_date":"2026-10-30","last_verified_at":"2026-11-02T18:25:32Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":3},"description":"Company Overview:\nBeam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.\nPosition Overview:\nBeam is seeking an experienced Director, Filing Excellence Program Manager to provide project leadership for major global regulatory submissions, including Biologics License Applications (BLAs), Marketing Authorization Applications (MAAs), and associated Health Authority review activities. Working closely with Regulatory Affairs and cross-functional leaders, this role will translate regulatory strategy into an integrated execution plan that aligns content development, data availability, submission readiness, and review-cycle activities.\nThis individual will drive the end-to-end submission operating model, establishing the critical path, governance, decision-making forums, risk management, and readiness processes required to deliver high-quality submissions on time. The Director will serve as a central point of integration across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations.\nThe ideal candidate is an experienced regulatory project leader who combines deep submission execution experience with strong cross-functional leadership, operational judgment, and the ability to create clarity and drive decisions in complex, fast-moving environments.\nResponsibilities:\nDrive integrated submission planning and execution by establishing and leading the end-to-end submission plan and critical path, including content development, data availability, review and approval cycles, publishing, submission, and Health Authority review.\nTranslate regulatory strategy into an executable operating plan by partnering with Regulatory Affairs and functional leaders to define deliverables, ownership, milestones, decision points, dependencies, and readiness criteria across submission modules and workstreams.\nLead cross-functional submission readiness across Regulatory, Clinical, Biostatistics, Data Management, CMC, Nonclinical, Safety, Quality, Medical Writing, Labeling, and Regulatory Operations, ensuring alignment of data, analyses, documents, and submission content.\nDrive critical submission milestones, including readiness for pre-submission Health Authority interactions, content completion, cross-functional reviews and approvals, quality-control activities, publishing handoffs, and final submission readiness assessments.\nEstablish submission governance and decision-making forums, with clear decision rights, escalation pathways, risk management, and executive reporting that enable rapid issue resolution and informed leadership decisions.\nProvide clear visibility to submission readiness through fit-for-purpose dashboards, milestone tracking, risk and decision logs, and executive reporting focused on critical-path status, emerging risks, resource constraints, and decisions required.\nLead rolling-submission planning and execution (when applicable) by defining module sequencing and associated content, data, review, approval, and publishing dependencies; identify timing risks and drive mitigation and recovery planning.\nLead Health Authority review-cycle execution, including cross-functional planning and rapid-response activities for information requests, labeling, inspection readiness, commitments, and other critical milestones through approval.\nFor FDA submissions, help integrate U.S. Prescribing Information (USPI), Pre-License Inspection (PLI), Bioresearch Monitoring (BIMO) inspection readiness, and launch readiness activities into the overall submission and review-cycle plan, ensuring clear ownership, dependencies, decision points, and cross-functional alignment through approval and launch.\nDrive resource and capacity planning for submission-critical workstreams, partnering with functional leaders to establish priorities, resolve competing demands, and implement recovery plans when needed.\nBuild scalable submission-management capabilities by establishing standardized plans, dashboards, workflows, and reporting practices using Smartsheet and other project-management tools.\nQualifications:\nBS in a scientific, technical, or related discipline required; advanced degree preferred.\nTypically 12 + years of experience with 10+ years of biotechnology or pharmaceutical industry experience, including significant leadership of complex, cross-functional programs or projects.\nDirect, hands-on experience leading the planning and execution of at least one major marketing application, preferably a BLA, through submission and Health Authority review.\nStrong understanding of eCTD structure, submission content dependencies, regulatory operations, and the end-to-end path from content development through review, approval, publishing, and submission.\nDemonstrated ability to lead integrated submission planning, governance, readiness assessments, risk management, and executive-level reporting.\nProven ability to influence across functions and organizational levels, drive decisions without direct authority, and maintain execution discipline in complex, fast-paced environments.\nExperience managing Health Authority information requests, inspection-readiness activities, labeling, or other post-submission review activities strongly preferred.\nExperience with cell or gene therapy programs and accelerated development or approval pathways preferred.\nProficiency with Smartsheet or comparable project-management, collaboration, and portfolio-planning tools.\nStrong facilitation, problem-solving, communication, and leadership skills, with the ability to translate complex information into clear priorities, actions, and decisions.\nCandidates must live locally and be able to work from Beam's Cambridge location 1 to 3 days per week as needed.\nThe salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.\nBeam Pay Range\n$210,000—$260,000 USD","description_format":"text","description_chars":6898,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Cell & Gene Therapy","Precision Medicine"],"lifecycle":[{"event":"open","at":"2026-10-31T00:07:36Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 9 · green card filings: 3","filings_12m":9,"filings_prev_12m":12,"green_card_filings_12m":3,"median_offered_wage_usd":130000,"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":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":29,"reasons":["conf:0","win:early"],"computed_at":"2026-11-02T06:13:15Z"},"pay":{"stated_usd_annual":260000,"is_top_pay":true},"html_url":"https://alion.io/job/beam-therapeutics-director-filing-excellence-program-manager","json_url":"https://alion.io/job/beam-therapeutics-director-filing-excellence-program-manager.json","meta":{"generated_at":"2026-11-02T20:27:17Z","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":28617,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-03T00:00:00Z"}},"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":1884200},"rest":"https://alion.io/mcp/rest/get_company?id=1884200"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbeam-therapeutics-director-filing-excellence-program-manager"},{"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%2Fbeam-therapeutics-director-filing-excellence-program-manager"},{"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%2Fbeam-therapeutics-director-filing-excellence-program-manager"},{"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/beam-therapeutics-director-filing-excellence-program-manager\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbeam-therapeutics-director-filing-excellence-program-manager"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3554403}},{"tool":"search_jobs","arguments":{"company":"beamtx.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3554403},"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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