Global Clinical Development Director — Remote & Strategy Lead

Cim

Northern (KY)

Hybrid

USD 180,000 - 240,000

Full time

7 days ago

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Job summary

Otsuka seeks a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products, remotely or in Princeton, NJ or Rockville, MD, under GCP. The incumbent will guide trials across rheumatology/immunology and specialty medicine for a global market.

Responsibilities include leading cross-functional teams, drafting program strategies, interpreting Phase I–IV results, and serving as signatory on NDA submissions, while managing CRO/vendor relationships and

Qualifications

Clinician with MD/DO and clinical medicine knowledge; leadership experience.
3–6 years in pharma or translational clinical research.
Strong communication, meeting facilitation and written/oral presentation skills.
Advanced understanding of drug development and regulatory requirements.
Willingness to travel up to 30% domestically and internationally.

Responsibilities

Designs and oversees clinical research programs and protocols for OPDC products.
Consults with clinical, regulatory, scientific leaders and stakeholders.
Authors program strategies and oversees essential trials for safety and efficacy.
Interprets Phase I–IV results for NDA submissions and regulatory interactions.
Oversees vendor/CRO governance and provides strategic input to filings.
Leads regulatory filing activities and documents with clinical input.