Chief Medical Officer

The Chief Medical Officer (CMO) serves as the organization’s senior medical and scientific authority, providing strategic leadership and governance across pharmaceutical drug and medical device development, manufacturing, and lifecycle management. The role ensures that all products are developed, manufactured, and commercialized in compliance with global regulatory requirements while meeting the highest standards of patient safety, product quality, and clinical integrity.

The CMO acts as the primary medical representative to regulatory authorities, executive leadership, and external stakeholders, ensuring that medical strategy aligns with corporate objectives, regulatory expectations, and public health responsibilities.

Key Accountabilities

The CMO is accountable for medical oversight across the full product lifecycle—from clinical development through post-market surveillance—while serving as a key executive advisor to the President and Board.

Core Responsibilities

1. Medical & Scientific Leadership

• Serve as the organization’s senior medical authority for pharmaceutical drugs and combination products (drug-device).
• Establish and execute the enterprise medical strategy aligned with business, regulatory, and patient safety objectives.
• Provide expert medical judgment on benefit–risk assessments, label claims, and clinical evidence.

2. Clinical Development Oversight

• Oversee clinical development strategy, including:
• Clinical trial design and protocol review
• Investigator engagement and oversight
• Data interpretation and medical conclusions
• Ensure clinical programs support regulatory submissions (IND, NDA, BLA, PMA, 510(k) as applicable).
• Chair or sponsor internal Medical Review Committees and Safety Review Boards.

3. Manufacturing & Quality Integration

• Partner with Manufacturing, Quality, and Regulatory Affairs to ensure:
• Medical input into process validation and change control
• Alignment of product specifications with clinical and safety expectations
• Robust medical rationale for deviations, CAPAs, and risk assessments
• Support Continuous Improvement initiatives affecting patient safety or clinical performance.

4. Regulatory & Agency Engagement

• Act as the senior medical representative to regulatory authorities (e.g., FDA, EMA, PMDA).
• Provide medical leadership during inspections, audits, advisory committee meetings, and regulatory hearings.
• Review and approve key medical sections of regulatory submissions and responses.

5. Pharmacovigilance & Post-Market Surveillance

• Maintain executive accountability for:
• Pharmacovigilance systems and medical device reporting (MDR)
• Signal detection, risk mitigation, and safety communications
• Review and sign off on safety reports (PSURs, DSURs, RMPs).
• Oversee medical response to recalls, field actions, and serious adverse events.

6. Compliance & Governance

• Ensure compliance with applicable laws and standards, including:
• FDA, EU MDR, ICH, GxP, HIPAA
• Clinical ethics and informed consent standards
• Promote a culture of medical ethics, transparency, and regulatory integrity.
• Serve as executive sponsor for medical SOPs and controlled documentation.

7. Cross-Functional Executive Partnership

• Collaborate with:
• Regulatory Affairs
• Quality & Manufacturing
• Commercial and Market Access teams
• Legal, Compliance, and Risk Management
• Provide medical input into lifecycle strategy, labeling, promotional review, and external communications.
• Build and lead a high-performing medical organization.
• Mentor medical leaders, physicians, and scientists.
• Ensure succession planning and continuous professional development across the medical function.

Required Education & Credentials

Mandatory

• MD or DO from an accredited medical school
• Active, unrestricted medical license (U.S. state license required; multi-state preferred)
• Board certification in a relevant specialty (e.g., Internal Medicine, Pharmacology, Pathology, or related)

Strongly Preferred

• Advanced degree such as PhD , MPH , or MBA
• Formal training or certification in pharmaceutical or clinical research

Required Experience

• 15+ years of progressively responsible medical leadership experience within:
• Pharmaceutical manufacturing
• Demonstrated experience supporting regulatory submissions and inspections.
• Executive-level experience interacting with FDA and global health authorities.
• Proven track record of leading multidisciplinary medical teams.

Company 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.

Disclaimer:

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request.