{"id":2282118,"url":"https://alion.io/job/biogen-clinical-development-lead","title":"Clinical Development Lead","company":{"id":449685,"name":"Biogen","domain":"biogen.com","url":"https://alion.io/company/biogen-2","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":23,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-19T05:45:15Z"}},"role":"Field & Service","role_family":"Field & Service","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Tokyo, Japan"],"countries":["JP"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":23000,"max_usd":59000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":1175},"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-06-11T00:00:00Z","employer_posted_date":"2026-06-11","last_verified_at":"2026-10-19T03:22:24Z","board_verified":true,"closed_at":null,"days_open":130,"trust":{"level":"stale","repost_count":0,"flags":["stale"],"days_open":130},"description":"Clinical Development Lead (CDL) is responsible for the overall Japan clinical development plan for assigned projects. CDL ensures studies are designed to fit Japan specific requirement and situation from clinical, regulatory, and operational perspectives. CDL is accountable for planning and execution of assigned clinical studies and leads communication with the external stakeholders (e.g. investigators, regulators, KMEs, academic societies). CDL is accountable for clinical contents of local study documents (e.g. protocols, IBs, ICFs) and regulatory documents (e.g. briefing books, responses to regulatory queries, CTDs).\nDevelops Integrated Development Plan (IDP): accountable for Japan clinical development strategiesProvides RDPT with necessary information including disease landscape, SOC, KMEs and competitor situation in Japan\nWorks collaboratively with the Project Team and PDC members to integrate the scientific rationale, regulatory requirements, operational feasibility, product development plan, and commercial goals to build a solid strategic framework for the Japanese components of the IDP\nLeads clinical development strategy discussion.\nEnsure that a Japanese strategic plan is fully aligned with a global strategy and is fully understood by a project team\n\nLeads clinical studies in assigned projects as an owner of the studies.Ensures the study protocol is applicable to Japanese medical practice and manages local protocol amendment, if necessary.\nEnsures that the resources and budget necessary for the successful execution of the trial are secured in collaboration with the CTM.\nAccountable for study feasibility in Japan\nAccountable for CRO and vendor selection and study budget.\nProactively identifies study level risks and drives execution of risk mitigation strategies\nAccountable for solving study related issues in Japan including management of AEs in collaboration with Study Medical Director and Safety Physician.\nMaintains study quality\nUnderstands the protocols and educate study team members\n\nLeads medical and scientific discussion as a Biogen Japan clinical representative with investigators and KMEs.\nServes as a local clinical representative in regulatory interactions in JapanPrepares and/or reviews clinical contents of regulatory submission documents and responses to clinical regulatory inquiries.\nParticipates in regulatory consultations and discussions\n\nEstablishes and maintains scientific reputation in academic societies by participating in major scientific conferences and making scientific presentations/publications.\nQualifications:\nScience background and education (Bachelor’s Degree or equivalent), MD/PhD/PharmD preferred\nStrong clinical credentials and/or drug development experiences in the therapeutic areas combined with strong grounding in scientific research.\nClinical development experience within in biopharmaceutical industry (at least 3 years in product development).\nExperience working with regulatory agencies (PMDA experience preferred)\nAbility to lead scientific discussion on mechanisms of new research approaches, clinical endpoints, protocol design, and data interpretation\nEstablished or has ability to establish peer level relationships with therapeutic area opinion leaders worldwide\nDemonstrated leadership and team building skills as well as the ability to perform effectively in a dynamic environment\nDemonstrated strategic and critical thinking\nExcellent communication skills (oral and written) with business level English and excellent organizational skills\nAbility to lead directly and by influence, including strong problem solving, conflict resolution, and analytical skills\nJob Level: ManagementWhy Biogen?\nWe are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.\nAt Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.\nAll qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.","description_format":"text","description_chars":5069,"description_truncated":false,"requirements":{"experience_years_min":3,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Japan","iso":"JP","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Neurology & CNS Therapeutics"],"lifecycle":[{"event":"open","at":"2026-10-11T12:02:13Z"}],"visa":[],"liveness":{"score":7,"band":"cold","label":"Long shot","p_open":1,"p_active":0.236,"p_room":0.28,"age_days":130,"expected_fill_days":29,"reasons":["conf:2","stale_co","velocity","win:tail","crowd:brand"],"computed_at":"2026-10-19T05:45:15Z"},"pay":null,"html_url":"https://alion.io/job/biogen-clinical-development-lead","json_url":"https://alion.io/job/biogen-clinical-development-lead.json","meta":{"generated_at":"2026-10-19T12:39:16Z","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":8702,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-20T00:00:00Z"}},"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":449685},"rest":"https://alion.io/mcp/rest/get_company?id=449685"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fbiogen-clinical-development-lead"},{"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%2Fbiogen-clinical-development-lead"},{"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%2Fbiogen-clinical-development-lead"},{"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/biogen-clinical-development-lead\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fbiogen-clinical-development-lead"}]}