{"id":3027962,"url":"https://alion.io/job/kailera-associate-directordirector-program-management-regulatory-submissions","title":"Associate Director/Director, Program Management (Regulatory Submissions)","company":{"id":678636,"name":"Kailera","domain":"kailera.com","url":"https://alion.io/company/kailera","size_band":"51-200","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":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":155000,"max":190000,"currency":"USD","period":"year","gross":null,"usd_annual":190000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"Smartsheet","optional":false}],"status":"live","first_seen_at":"2026-05-26T15:58:05Z","employer_posted_date":"2026-07-27","last_verified_at":"2026-11-01T02:51:10Z","board_verified":true,"closed_at":null,"days_open":158,"trust":{"level":"ok","repost_count":0,"flags":[],"days_open":157},"description":"At Kailera, we are bold, authentic and committed to our mission of developing therapies that give people the power to transform their lives and elevate their overall health. Rooted in an entrepreneurial spirit and a team-oriented culture, we are working together to advance Kailera’s mission to advance novel therapies for obesity and related conditions.\nWe are passionate about creating an inclusive workplace that promotes collaboration, integrity, and excellence. As we expand, we seek the most talented individuals with diverse backgrounds, cultures, perspectives, and experiences to join our team.\nWhat You’ll Do:\nThe Associate Director/Director, Program Management will collaborate with cross-functional teams, including clinical, regulatory, non-clinical, and technical operations, to lead regional and global cross-functional teams in the planning, preparation, and delivery of compliant marketing authorization filings. This individual will oversee the development and execution of project plans from initiation to completion, ensuring the plan is completed on time, in scope, and within budget. Additionally, they will work closely with teams to proactively identify potential risks and implement effective solutions. A successful candidate must have experience managing drug development projects, particularly initial marketing authorization applications, in a fast-paced environment, with a strong willingness to build relationships with cross-functional teams, dive into details, and address gaps as needed to ensure program success.\nResponsibilities:\nContribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements\nLead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)\nOversee project team delivery of the marketing authorization applications\nDevelop and own detailed integrated marketing authorization plans, including goals, deliverables, timelines, and resource requirements\nMonitor project progress and provide regular updates to Program Leader and other stakeholders, ensuring clear communication and transparency\nOwn program reports / dashboards to executive and other governance teams\nEstablish best practices and SOPs as needed for marketing application related submission processes\n\nRequired Qualifications:\n10+ years of relevant experience of project management experience in the biotech, pharmaceutical, or life sciences industry\nStrong understanding of drug development and how biotech functions integrate\nExperience in managing cross-functional teams and complex projects inate-stage drug development, with experience managing global marketing authorization submissions (NDA, BLA, MAA) preferred\nDemonstrated project management and interpersonal skills\nExcellent problem-solving and organizational skills, attention to detail, and analytical skills\nAbility to manage multiple priorities in a fast-paced, dynamic environment\nComfortable navigating ambiguity and driving clarity\nResponds to changing priorities and uncertainty by maintaining composure, resilience, and an open mind while embracing change in an evolving environment\nProven record of collaboration and excellent communication\nProficient in project management tools (e.g., Smartsheet, MS Project, Excel, think-cell, OnePager)\n\nEducation:\nBachelor’s degree in science, engineering, or a related field; advanced degree preferredAssociate Director: advanced degree 5+ years of experience\nDirector: advanced degree 8+ years of experience\n\nThis role may be hired at the Associate Director or Director level depending on candidate experience or business need.\nSalary Range\n$155,000—$190,000 USD\nSalary Range (Associate Director)\n$155,000—$190,000 USD\nSalary Range (Director)\n$192,000—$235,000 USD\nFor Full Time Roles: This range represents the company’s good-faith estimate of the salary at the time of posting. Actual pay may vary based on experience, skills, qualifications, location, and internal equity. We also offer comprehensive health coverage, flexible time off, paid holidays, and a year-end shutdown. Enjoy a monthly wellness stipend, generous 401(k) match, tuition reimbursement, commuter benefits, disability and life insurance, plus annual bonus opportunities and equity grants-because your well-being and future matter to us.\nEQUAL EMPLOYMENT OPPORTUNITY INFORMATION: \nKailera Therapeutics, Inc. is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race (including traits historically associated with race, such as hair texture and protective hairstyles), color, creed, religion (including religious dress and grooming practices), national origin, ancestry, citizenship status, age (40 and over), sex or gender (including pregnancy, childbirth, pregnancy-related conditions, and lactation), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, reproductive health decisions, domestic victim status, political affiliation, or any other characteristic protected by applicable federal, state, or local laws and ordinances.\nE-Verify:\nKailera Therapeutics, Inc. uses E-Verify to confirm the identity and employment eligibility of all new hires.\n #LI-Hybrid","description_format":"text","description_chars":5365,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Equity","Flexible time off","Life insurance"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Drug Discovery","Cardiometabolic Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-21T19:37:38Z"}],"visa":[],"liveness":{"score":16,"band":"cold","label":"Long shot","p_open":1,"p_active":0.581,"p_room":0.28,"age_days":157,"expected_fill_days":69,"reasons":["conf:1","win:tail","crowd:"],"computed_at":"2026-10-31T05:58:55Z"},"pay":{"stated_usd_annual":190000,"is_top_pay":false},"html_url":"https://alion.io/job/kailera-associate-directordirector-program-management-regulatory-submissions","json_url":"https://alion.io/job/kailera-associate-directordirector-program-management-regulatory-submissions.json","meta":{"generated_at":"2026-11-01T05:44:46Z","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":8868,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-02T00:00:00Z"}},"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":678636},"rest":"https://alion.io/mcp/rest/get_company?id=678636"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fkailera-associate-directordirector-program-management-regulatory-submissions"},{"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%2Fkailera-associate-directordirector-program-management-regulatory-submissions"},{"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%2Fkailera-associate-directordirector-program-management-regulatory-submissions"},{"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/kailera-associate-directordirector-program-management-regulatory-submissions\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fkailera-associate-directordirector-program-management-regulatory-submissions"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3027962}},{"tool":"search_jobs","arguments":{"company":"kailera.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3027962},"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. Docs: https://alion.io/developers"}}