Remote Senior Director, Global Clinical Development

Otsuka America Pharmaceutical Inc.; Annapolis (MD); Remoto; USD 180.000 - 250.000; Tempo pieno

Descrizione del lavoro

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, remote-based or in Rockville, MD or Princeton, NJ. You will design and oversee clinical research programs and protocols for OPDC products under good clinical practices (GCP).

The incumbent will evaluate CNS and Digital Medicine products for a global healthcare market, leading cross-functional teams and strategic regulatory activities.

Competenze

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist with management experience.

Mansioni

• Designs and oversees clinical research programs and protocols for OPDC products under GCP.
• Evaluates and develops CNS and Digital Medicine products for a global market.
• Acts as internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical, and other teams.
• Authors program strategies and study reports; oversees trials essential for determining safety, efficacy and value.
• Interprets and communicates results of Phase I–IV investigations for NDA submissions and regulatory filings.
• Provides strategic oversight of vendor and CRO relationships and governance.
• Leads regulatory filing activities and drafts concise regulatory communications.
• Willingness to travel up to 30% of the time and travel internationally.

Conoscenze

MD/DO physician

Management experience

Clinical medicine knowledge

Communication skills

MS Office

Leadership ability

Drug development knowledge

Formazione

MD/DO medical degree

PhD/MPH/MBA a plus

Strumenti

Microsoft Office

Descrizione del lavoro

Otsuka Pharmaceutical Company seeks a Senior Director, Global Clinical Development, remote-based or in Rockville, MD or Princeton, NJ. You will design and oversee clinical research programs and protocols for OPDC products under good clinical practices (GCP).

The incumbent will evaluate CNS and Digital Medicine products for a global healthcare market, leading cross-functional teams and strategic regulatory activities.