Associate Director, Bioanalysis

Otsuka America Pharmaceutical Inc.; Salem (OR); Remote; USD 169.000 - 253.000; Vollzeit

Zusammenfassung

Otsuka America Pharmaceutical, Inc. is seeking an Associate Director, Bioanalysis to provide strategic and scientific oversight for outsourced bioanalytical activities supporting clinical development, with emphasis on PK and biomarkers.

Lead CRO interactions, ensure timely, audit-ready data, and guide assay strategy and validation across programs. The role demands deep expertise in LC-MS/MS, immunogenicity assays, and biomarker strategies, plus ability to communicate complex science to diverse

Qualifikationen

• Ph.D. with at least 5 years of regulated bioanalysis experience.
• Experience in PK and biomarker assays.
• Knowledge of global bioanalytical regulatory guidance.
• Hands-on experience with LC-MS/MS, ELISA, ECL, and flow cytometry.
• Experience with ADA/NAb assays is a plus.
• Experience managing CROs and external partnerships.
• Strong project management and multitasking.
• Excellent communication across technical and non-technical audiences.
• Ability to influence decisions in cross-functional teams.

Aufgaben

• Provide strategic and scientific leadership for outsourced bioanalytical activities.
• Oversee method development, qualification, validation, and sample analysis.
• Develop and maintain partnerships with bioanalytical CROs and vendors.
• Monitor vendor performance, timelines, quality, and compliance.
• Ensure activities meet regulatory guidance and industry best practices.
• Serve as SME on cross-functional project teams, providing risk assessments.
• Support regulatory submissions with study docs and agency responses.
• Identify emerging technologies and biomarker strategies.
• Drive continuous improvement and adopt new technologies and digital solutions.

Kenntnisse

Bioanalysis oversight

CRO management

Mass spectrometry

LBA

Cell-based assays

Regulatory knowledge

Project management

Communication skills

Ausbildung

Ph.D. with 5+ years experience

M.S./B.S. with 8+ years experience

Tools

LC-MS/MS

ELISA

ECL

Flow cytometry

Jobbeschreibung

Remote

Full time

R12891

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.

The 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.

This 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.

In 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.

The 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.

Key responsibilities

• Provide strategic and scientific leadership for outsourced bioanalytical activities supporting clinical development programs.

• Oversee bioanalytical method development, qualification, validation, and sample analysis activities, including scientific troubleshooting and optimization.

• Develop and maintain strong partnerships with bioanalytical CROs and other external vendors to ensure successful execution of bioanalytical strategies.

• Monitor vendor performance and ensure adherence to study timelines, quality standards, contractual obligations, and regulatory requirements.

• Ensure bioanalytical activities are conducted and documented in accordance with applicable global regulatory guidance and industry best practices.

• Serve as the bioanalytical subject matter expert on cross‑functional project teams, providing scientific recommendations and risk assessments to support decision making.

• Support regulatory submissions by contributing to and reviewing submission‑related documents, responses to agency questions, and inspection‑readiness activities.

• Identify and evaluate emerging analytical technologies, biomarker strategies, and innovative measurement approaches that may enhance clinical development programs.

• Drive continuous improvement initiatives and champion new technologies, digital solutions, and operational efficiencies within the bioanalysis function.

Qualifications

• Ph.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.

• Demonstrated expertise in regulated bioanalysis supporting clinical development, including pharmacokinetic and biomarker assays

• Strong knowledge of global bioanalytical regulatory guidance and industry standards

• Hands‑on experience and understanding of bioanalytical technologies, including LC‑MS/MS, ELISA, ECL, flow cytometry, and other relevant platforms.

• Experience with immunogenicity assays, including anti‑drug antibody (ADA) and neutralizing antibody (NAb) assays, is a plus.

• Experience managing CROs and external partnerships, including oversight of deliverables, budgets, timelines, quality, and compliance.

• Strong project management skills with the ability to prioritize and manage multiple complex programs simultaneously.

• Excellent verbal, written, and presentation skills, with the ability to communicate complex scientific information effectively to technical and non‑technical stakeholders.

• Demonstrated ability to work collaboratively in cross‑functional teams and influence decision making.

Competencies

Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

Strategic Thinking & Problem Solving - Make decisions considering the long‑term impact to customers, patients, employees, and the business.

Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.

Empowered Development - Play an active role in professional development as a business imperative.

Minimum $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.

Company 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.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112 .

Otsuka 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.

If 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 [e-mail] .

Otsuka Pharmaceutical Co., Ltd. is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.” In the U.S., Otsuka is comprised of two companies, Otsuka America Pharmaceutical, Inc., and Otsuka Pharmaceutical Development & Commercialization, Inc., that share a deep commitment to the development and commercialization of innovative products in the spaces of neuroscience, nephrology, and digital medicine.

Driven by our purpose to defy limitation, so that others can too, we have an unwavering belief in doing more and transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep‑rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

OPDC and OAPI are indirect subsidiaries of Otsuka Pharmaceutical Company, Ltd., which is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 34,400 people worldwide and had consolidated sales of approximately USD 14.2 billion in 2023.