Associate Director, Translational Research and Biomarkers Otsuka
- 3.7 Princeton, NJ Job Details Full-time $169,222
- $253,000 a year 2 hours ago Benefits AD&D insurance Paid holidays Disability insurance Health insurance Dental insurance Tuition reimbursement Career development plan Vision insurance 401(k) matching Loan assistance Life insurance Prescription drug insurance Qualifications Data visualization software proficiency Molecular biomarkers Design of experiments DNA sequencing Flow cytometers Assay development Molecular biology techniques Clinical research compliance Clinical program data analysis Vendor relationship management Managing projects Research regulatory compliance Gene expression analysis Clinical data analysis Translational research Clinical trial support in drug product development Research findings presentation Bioinformatics data analysis Pharmaceutical research Cytometry Cross-functional communication Data analysis software Molecular analysis Full Job Description Job Summary Otsuka is looking for a naturally curious, self-motivated individual to join the Translational Research and Biomarkers team.
Innovative projects that focus on bringing solutions to clinical programs, such as
- omics analysis for the elucidation of mechanism of action and identification and selection of mechanism-based pharmacodynamic markers, patient enrichment approaches to improve clinical trial design, and genetic variant correlation with clinical assessments are just a part of what we invest our energy in.
If you are looking for an opportunity to pioneer in the field of translational research and biomarkers in clinical trials that will ultimately impact the lives of patients, look no further. The Associate Director of Translational Research and Biomarkers is an integral member of the Translational Biomarkers team and plays a pivotal role in advancing drug candidates from preclinical research through clinical development. This position requires expertise in immunology and nephology, clinical translational research, and data analysis, visualization and interpretation. Reporting to the Senior Director, Translational Research and Biomarkers, the Associate Director will collaborate closely with cross-functional partners across Research, Nonclinical, Bioanalytical, Regulatory, Clinical Operations, Quantitative Pharmacology, and Medical teams. This role is responsible for overseeing outsourced biomarker measurements in biological fluids and tissues to support clinical development programs. The Associate Director will manage external partnerships with contract research organizations, laboratories, and academic collaborators, ensuring high-quality, timely execution of biomarker strategies. The Associate Director will integrate target engagement, pharmacodynamic, pathway biology, and disease biology data to generate mechanistic insights that inform drug development decisions. This role also supports exploratory clinical data analyses using robust statistical and data visualization approaches. Additionally, the Associate Director ensures compliance with global regulatory guidelines for biomarker data generation, reporting, and submissions, when applicable. The individual will contribute to the design and implementation of innovative biomarker and genomic strategies, working collaboratively with internal teams and external partners—including academic institutions and research organizations—to advance translational research capabilities. This position can be located in either Princeton, NJ or Rockville, MD. Job Description Participate as a key member of cross-functional project teams supporting asset development programs with active biomarker initiatives. Collaborate effectively within a cross-functional, matrixed environment—including Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams—to refine translational hypotheses and deliver high-quality, program-critical outputs on accelerated timelines. Contribute to the design and advancement of scientifically rigorous biomarker and clinical development strategies, including indication and patient population selection, TE/PD biomarker integration, and MoA hypothesis development. Contribute to the selection, outsourcing, and execution of biomarker assays in biological matrices, and manage external vendors to ensure quality and timeliness. Develop and implement biomarker analysis plans and support high-quality data generation for interim and final clinical analyses. Ensure compliance with global regulatory requirements and contribute to the preparation, review, and interpretation of biomarker-related clinical and regulatory documents. Evaluate, recommend, and help defend the adoption of emerging technologies and innovative approaches to enable biomarker measurement in biological matrices for clinical trials. Qualifications PhD or MS with a minimum of 5 years of relevant experience in clinical research or clinical trial execution within immunology/nephrology. Demonstrated experience designing and executing biomarker and genomics research, with a proven ability to analyze, interpret, and translate data to support drug development and inform clinical trial design. Strong expertise across a broad range of biochemical, molecular, and cellular assay platforms, as well as bioinformatics approaches, including RNA-Seq, exome and whole genome sequencing, high-throughput proteomics, and multiplex flow cytometry. Working knowledge of digital biomarker applications and their integration into clinical development programs. Experience managing external vendors, including oversight of timelines, deliverables, contractual obligations, and regulatory compliance. Proven ability to manage and contribute to multiple programs at different stages of development, effectively prioritizing work in a fast-paced environment with evolving timelines. Demonstrated ability to translate insights from scientific literature into the design, execution, and interpretation of complex experiments and research strategies. Excellent verbal and written communication skills, with the ability to clearly present complex scientific concepts and data to diverse cross-functional audiences. Travel (approximately 10%) 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://www.otsuka-us.com/careers-join-otsuka .
Disclaimer:
This 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. 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 Accommodation Request . Statement Regarding Job Recruiting Fraud Scams At 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. Please 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. Otsuka 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. To 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 . Otsuka 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. Otsuka 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.
