Director, Global Clinical Development

About the role

OPDC-GCD is a group of physicians and scientists who lead clinical development activities for Otsuka’s global health-care products. Our team is collaborative, innovative with a mantra of “acting as though the company was our own.” Responsibilities range from due-diligence evaluations to developing global development & commercialization plans (GDCP).

Responsibilities

• Consults with patients or their representatives, clinical, regulatory and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.
• Develops focused expertise to serve as an internal medical/scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
• Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interprets and communicates results of Phase I-IV investigations in preparation for a new drug.
• Acts as the signatory on NDA submissions and clinical study and safety documents.
• Provides strategic oversight in our vendor and CRO relationships, and provides clinical input into their governance committees.
• Helps lead and support regulatory filing activities and documents.
• Provides strategic direction and editing to provide concise, clear and convincing argumentation in all such written and verbal communications.

Qualifications

• A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect).
• Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D.) may be considered if complemented by a team or consulting clinician.
• Experience in the pharmaceutical industry or in academic translational clinical research 6+ years is typically required depending on type of experience at application.

Pay

$209,599.00 - $313,375.00, plus incentive opportunity.

Schedule

Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.

Benefits

Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.