Director, Translational Medicine

5-10 years

Not Disclosed

Princeton Junction

10 Oct. 22, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Director of Translational Medicine

Company: Otsuka Pharmaceutical Company
Location: Rockville, Maryland or Princeton, New Jersey (Hybrid; Remote options available for US candidates)
Travel: Expected 20% based on business needs

Otsuka Pharmaceutical Company is a global healthcare leader committed to “Otsuka-people creating new products for better health worldwide.” We research, develop, manufacture, and market innovative pharmaceutical and nutraceutical products to meet unmet medical needs and support everyday health.

Job Overview

As the Director of Translational Medicine, you will embody Otsuka’s culture and values, overseeing the design, execution, and reporting of First in Human (FIH), Translational Medicine (TM), and Proof of Concept (POC) studies. You will collaborate with teams across Discovery, Preclinical, Biomarker, Genomics, Bioanalytical, and Global Clinical Development to ensure efficient execution of early-phase trials and development of biomarker plans.

Key Responsibilities

Chair the Research and Development team (RDT) to ensure execution and reporting of FIH, Experimental Medicine, TM, and POC studies.
Prepare study designs, outlines, and finalize study protocols.
Provide medical oversight for early-phase studies, including protocol development and interaction with medical monitors.
Identify and implement the latest biomarker and translational tools to support Otsuka’s pipeline.
Collaborate with internal and external research organizations to facilitate early-phase development.
Advise stakeholders on incorporating translational tools in early development and make go/no-go decisions.
Support the development of biomarker plans for each compound in collaboration with relevant functions.
Work with Strategy and Commercial teams on target validation and discovery of new compounds.
Author or review clinical study protocols, investigator brochures, study reports, INDs, NDAs, and CTAs.

Qualifications

Education: MD or MD/PhD in Pharmacology, Neuropsychopharmacology, or a related field.
Experience: 5-10 years in designing, executing, and reporting FIH and translational studies.
In-depth knowledge of translational medicine and pharmacology, including models and guidance documents.

Preferred Skills

Strong leadership in Early Phase and Translational Medicine.
Excellent communication skills and ability to adapt to changing situations.
Track record in early clinical drug development and operational understanding.

Benefits

Comprehensive medical, dental, vision, and prescription drug coverage.
Company-provided life and disability insurance.
Tuition reimbursement and 401(k) match.
Paid time off and paid leave programs.

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