Global Clinical Development Lead, CNS & Digital Medicine

Texas Health Institute

Princeton, Northern (NJ, KY)

Hybrid

USD 180,000 - 230,000

Full time

2 days ago

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Job summary

Otsuka is seeking a Director, Global Clinical Development to design and oversee clinical research programs for OPDC products. The role is based in Rockville, MD or Princeton, NJ and requires a medical degree with substantial industry experience under GCP guidelines.

The candidate will supervise trials across CNS and digital medicine, interact with regulators, and shape program strategies while guiding vendor relations and cross-functional teams. Travel is expected.

Qualifications

MD/DO or equivalent medical degree with clinical qualification.
6+ years in pharmaceutical industry or translational clinical research depending on experience.
Direct or indirect management experience in a relevant setting.

Responsibilities

Designs and oversees clinical research programs and protocols in line with GCP.
Serves as internal medical/scientific consultant to cross-functional teams and external regulators.
Authors program strategies and oversees trials to determine safety, efficacy, and value of product candidates.
Leads regulatory filings and provides strategic direction for submissions.
Manages vendor and CRO relationships and governance.
Travel up to 30% and support global regulatory filings.