DIRECTOR, TRANSLATIONAL MEDICINE (TM)

Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy : Otsuka-people creating new products for better health worldwide.

Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.

As a Director of Translational Medicine, you will be a champion of Otsuka's culture and values, and will be responsible for design, execution, oversight and reporting of First in Human (FIH), Translational Medicine (TM) and Proof of Concept (POC) studies and will work with Discovery, Preclinical, Biomarker, Genomics, Bioanalytical and Global Clinical Development teams to ensure efficient and scientific execution of early phase trials and development / execution of biomarker plans and identification and utilization of new biomarker and translational tools, new technologies and scientific capabilities to support Otsuka's pipeline.

The Director TM works with digital and diagnostics groups to support development of biomarkers throughout life cycle of Otsuka's compounds.

You will represent TM at teams to identify, introduce, and evaluate discovery assets and ensures incorporation of translational tools in early phase programs.

You will participate in the Early Development Team (EDT) or serve as chair of Research and Development team (RDT) and support transition of discovery compounds from preclinical stage to first in human and POC and provides medical oversight of ongoing studies and input to strategy and commercial teams for asset and indication mapping.

At study level, The Director of TM will serve as the medical oversight of the study and oversee protocol development, study execution while working with medical monitor and other functions and activities related to Clinical Study Report (CSR).

The Director of TM, in alignment with Head of the Translational Medicine, will participate in Key Opinion Leader (KOL) meetings, advisory boards, academic and scientific groups to ensure evaluation and incorporation of innovative translational and biomarker endpoint in early phase programs.

This position is based in Rockville, Maryland or Princeton, New Jersey. Otsuka maintains a hybrid work policy and travel is expected 20% of the time based on business needs.

Remote options will be considered for US candidates.

Job Description :

• Serve as chair of RDT to ensure execution and reporting of FIH, Experimental Medicine, Translational Medicine or POC studies.
• Prepare study design, study outline, participate in defense of FIH, Experimental Medicine, Translational Medicine or POC studies in review meetings, review and finalize study protocols.
• Serve in the role of medical oversight of early phase studies and oversee protocol development, study execution, interaction with medical monitor and other cross functional stake holders.
• Support identification and utilization of latest Biomarker, Translational tools, new technologies and scientific capabilities to support Otsuka's pipeline.
• Partner with internal and external research organizations to expand and facilitate development of early phase and discovery phase compounds and Translational tools.
• Provide expert advice to internal and external stakeholders and interact with subject matter experts for early development and go / no go decisions.
• Provide expert advice to internal and external discovery teams and academic and early investment partners on incorporation of Translational tools and studies in early development, lead optimization and go / no go decisions.
• Collaborate with internal and external discovery teams and BD, MSRD on activities related to early phase target and asset identification.
• Support development of biomarker plans for each compound in alignment with functional head and collaboration with Biomarker, Genomics and Bioanalytical, Digital, and other functions for early go / no go decisions, patient stratification and dose selection.
• Work in close collaboration with Strategy and Commercial teams to identify new modalities and targets and execute internal and external Translational studies for target validation and discovery of new compounds.
• Develop and implement scientifically driven yet practical clinical biomarker and translational plans to address important program-level questions with cross-functional team.
• Serve as EDT member or RDT chair for multiple early Phase and discovery programs.
• Author or review and clinical study protocols, investigator brochures, study reports, INDs, NDAs and CTAs.
• Demonstrate a track record in early clinical drug development, including the principles of clinical pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for implementation

Minimum Qualifications :

• MD or MD / PhD in Pharmacology, Neuropsychopharmacology (or a related area) with a minimum 5-10 years of experience.
• In-depth experience in design, execution and reporting of first in Human, Translational studies and biomarker research.
• Medical oversight of FIH, Experimental Medicine, Translational Medicine or POC studies.
• In-depth knowledge of Translational Medicine, Pharmacology, Neuropsychopharmacology Translational and Pharmacology models.
• Great working knowledge of drug development, clinical development, biomarker, and translational tools.
• In depth knowledge of the latest developments in clinical pharmacology, and guidance documents.

Preferred Knowledge, Skills, and Abilities :

• Must be able to apply scientific knowledge (in the areas specified above) to further our products, anticipate and identify core problems, apply analysis, and solve problems effectively.
• Strong leadership experience related to Early Phase and Translational Medicine.
• Strong communication skills.
• Flexibility to react rapidly to changing situations / environment.

Our Benefits :

• Comprehensive medical, dental, vision and prescription drug coverage
• Company provided Basic Life, AD&D, Short-term and Long-term Disability insurance
• Tuition reimbursement
• 401(k) match
• PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits

LI-Remote

LI-Hybrid

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.

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 ODH, 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.