Global Medical Safety Director (Psychedelics) — Remote

Otsuka America Pharmaceutical Inc.; Dover (DE); Remote; USD 250,000 - 388,000; Full time

Benefits offered by this job

Medical, dental, vision coverage

401(k) retirement plan with match

Tuition reimbursement

Paid holidays and leave programs

Comprehensive life and disability ins.

Job summary

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Medical Safety to lead safety strategy for late-stage psychedelic portfolios. You’ll monitor risk, guide regulatory submissions, and ensure scientific integrity in safety evaluations.

The role requires MD with US license, extensive PV expertise, and strong cross-functional collaboration across GRA, GCD, CM, and GPV teams. Remote option with global scope and leadership responsibilities.

Qualifications

• MD with medical license and at least 10 years in pharmacovigilance/med safety.
• Proven track record in global regulatory submissions (IND/NDA/MAA).
• Experience with psychedelic clinical programs is preferred.

Responsibilities

• Lead and advance safety strategy for late-stage psychedelic assets.
• Author and review safety content for regulatory submissions.
• Define safety monitoring and risk mitigation plans across programs.
• Represent Global Safety in regulatory interactions and governance meetings.
• Mentor GPV Associates and Safety physicians, and drive training.

Skills

Medical safety leadership

Clinical safety

Regulatory strategy

Cross-functional leadership

Risk management

Strategic thinking

Global/pharmacovigilance

Communication skills

Education

MD degree

US medical license

Job description

Otsuka America Pharmaceutical Inc. is seeking a Senior Director of Global Medical Safety to lead safety strategy for late-stage psychedelic portfolios. You’ll monitor risk, guide regulatory submissions, and ensure scientific integrity in safety evaluations.

The role requires MD with US license, extensive PV expertise, and strong cross-functional collaboration across GRA, GCD, CM, and GPV teams. Remote option with global scope and leadership responsibilities.