{"id":4256420,"url":"https://alion.io/job/otsuka-us-associate-director-bioanalysis","title":"Associate Director, Bioanalysis","company":{"id":1794798,"name":"Otsuka US","domain":"otsuka-us.com","url":"https://alion.io/company/otsuka-us","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"head","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"posting_text","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":169222,"max":253000,"currency":"USD","period":"year","gross":null,"usd_annual":253000},"salary_estimate":null,"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"ELISA","optional":false},{"name":"Flow Cytometry","optional":false},{"name":"Mass Spectrometry","optional":false},{"name":"Gmail","optional":true}],"status":"live","first_seen_at":"2026-11-11T00:00:00Z","employer_posted_date":"2026-11-11","last_verified_at":"2026-11-13T14:14:21Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"Otsuka is seeking a highly motivated and scientifically driven professional to join the Bioanalysis team. The team provides bioanalytical oversight for clinical development programs through management of external laboratory partners and collaboration with cross-functional stakeholders. Beyond supporting regulated bioanalysis, this role offers opportunities to drive process improvements, evaluate emerging analytical technologies, and contribute to the continued advancement of bioanalytical capabilities across the development portfolio.\nThe Associate Director, Bioanalysis is responsible for providing strategic and scientific oversight of outsourced bioanalytical activities supporting clinical development programs, with a primary focus on pharmacokinetics (PK) and biomarkers. The successful candidate will possess deep expertise in bioanalytical sciences, particularly mass spectrometry-based assays, ligand-binding assays (LBA), and cell-based methodologies, along with a strong understanding of global bioanalytical regulatory requirements.\nThis individual will lead interactions with external contract research organizations (CROs), ensuring the timely delivery of high-quality, audit-ready, and submission-ready bioanalytical data. The Associate Director will provide scientific leadership in assay strategy, method development, validation, and troubleshooting while ensuring the integrity and efficiency of bioanalytical data flow throughout clinical development.\nIn addition, the Associate Director will actively assess emerging technologies, industry trends, and innovative measurement approaches that can enhance clinical trial execution and data quality. The role requires effective collaboration with cross-functional stakeholders and the ability to communicate complex scientific concepts to diverse audiences.\nThe ideal candidate is a proactive problem solver with strong scientific judgment, excellent communication skills, and the ability to manage multiple projects simultaneously in a fast-paced environment.\nKey responsibilities\nProvide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.\n\nOversee bioanalytical method development, qualification, validation, and sample analysis activities, including scientific troubleshooting and optimization.\n\nDevelop and maintain strong partnerships with bioanalytical CROs and other external vendors to ensure successful execution of bioanalytical strategies.\n\nMonitor vendor performance and ensure adherence to study timelines, quality standards, contractual obligations, and regulatory requirements.\n\nEnsure bioanalytical activities are conducted and documented in accordance with applicable global regulatory guidance and industry best practices.\n\nServe as the bioanalytical subject matter expert on cross-functional project teams, providing scientific recommendations and risk assessments to support decision making.\n\nSupport regulatory submissions by contributing to and reviewing submission-related documents, responses to agency questions, and inspection-readiness activities.\n\nIdentify and evaluate emerging analytical technologies, biomarker strategies, and innovative measurement approaches that may enhance clinical development programs.\n\nDrive continuous improvement initiatives and champion new technologies, digital solutions, and operational efficiencies within the bioanalysis function.\n\nQualifications\nPh.D. with a minimum of 5 years of relevant industry experience in regulated bioanalysis; or M.S. or B.S. degree with a minimum of 8 years of relevant industry experience.\n\nDemonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays\n\nStrong knowledge of global bioanalytical regulatory guidance and industry standards\n\nHands-on experience and understanding of bioanalytical technologies, including LC-MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms.\n\nExperience with immunogenicity assays, including anti-drug antibody (ADA) and neutralizing antibody (NAb) assays, is a plus.\n\nExperience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance.\n\nStrong project management skills with the ability to prioritize and manage multiple complex programs simultaneously.\n\nExcellent verbal, written, and presentation skills, with the ability to communicate complex scientific information effectively to technical and non-technical stakeholders.\n\nDemonstrated ability to work collaboratively in cross-functional teams and influence decision making.\n\nCompetencies\nAccountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.\nStrategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.\nPatient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.\nImpactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.\nRespectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.\nEmpowered Development - Play an active role in professional development as a business imperative.\nMinimum $169,222.00 - Maximum $253,000.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate’s job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.Application Deadline: This will be posted for a minimum of 5 business days.\nCompany benefits: Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.\nCome discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.\nJoin Our Talent Community: Stay connected with Otsuka by joining our Talent Community. Tell us about your interests, and we’ll notify you about future opportunities that align with your background. https://community.hireez.com/cielo-otsuka/82cb3591\nDisclaimer:\nThis job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.\nOtsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.\nIf you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting .\nStatement Regarding Job Recruiting Fraud Scams\nAt Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.\nPlease understand, Otsuka will never ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.\nOtsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.\nTo ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website https://vhr-otsuka.wd1.myworkdayjobs.com/en-US/External.\nOtsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka’s call center at: 800-363-5670. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: https://www.ic3.gov, or your local authorities.\nOtsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.","description_format":"text","description_chars":10778,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"phd","optional":false},"security_clearance":false,"languages":[]},"benefits":["Flexible time off","Professional development"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Health Care"],"lifecycle":[{"event":"open","at":"2026-11-13T14:14:21Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":2,"expected_fill_days":22,"reasons":["conf:1","win:early","comp:brand"],"computed_at":"2026-11-13T15:59:14Z"},"pay":{"stated_usd_annual":253000,"is_top_pay":false},"html_url":"https://alion.io/job/otsuka-us-associate-director-bioanalysis","json_url":"https://alion.io/job/otsuka-us-associate-director-bioanalysis.json","meta":{"generated_at":"2026-11-13T15:59:14Z","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":32047,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-14T00:00:00Z"}},"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":1794798},"rest":"https://alion.io/mcp/rest/get_company?id=1794798"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fotsuka-us-associate-director-bioanalysis"},{"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%2Fotsuka-us-associate-director-bioanalysis"},{"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%2Fotsuka-us-associate-director-bioanalysis"},{"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/otsuka-us-associate-director-bioanalysis\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fotsuka-us-associate-director-bioanalysis"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":4256420}},{"tool":"search_jobs","arguments":{"company":"otsuka-us.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":4256420},"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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