The Director, Corporate Counsel will serve as a strategic legal advisor supporting U.S. commercial activities for one or more rare disease products. This role provides pragmatic, day-to-day legal counsel to brand, marketing, and cross-functional stakeholders, with a strong focus on advertising and promotion, product launch readiness, and commercialization strategy across the product lifecycle.

This attorney will operate as a key partner to Commercial, Medical, Regulatory, and Promotion Compliance teams, delivering risk-based legal guidance in a fast-paced, highly regulated environment. The role requires deep understanding of FDA promotional requirements, healthcare fraud and abuse laws, and the unique legal and regulatory considerations associated with rare disease products, including disease awareness, patient identification, and specialized treatment pathways as well as sound judgment, strong cross-functional partnership skills, and the ability to deliver practical, risk-based advice in a fast-paced environment.

The ideal candidate must be able to competently and effectively evaluate legal risk and provide practical, business-oriented recommendations. A demonstrated ability to (i) ensure materials are consistent with FDA-approved labeling and compliant with applicable laws, regulations, and industry standards; (ii) provide legal guidance on promotional claims, disease state education, and scientific communications, particularly in complex or specialized rare disease contexts; (iii) monitor evolving regulatory requirements, guidance documents, and enforcement activity, and translate into actionable advice; (iv) partner closely with Promotion Compliance and Regulatory Affairs to ensure aligned, consistent guidance; (v) evaluate legal risk and provide practical, business-oriented recommendations; and (vi) collaborate with a variety of cross-functional partners, including Commercial, Medical Affairs, Regulatory Affairs, Ethic and Compliance, Privacy, Corporate Affairs and Communications, and Market Access and Channel teams.

Experience with contract drafting and negotiation is not required, but would be highly valued, particularly with respect to market access and channel arrangements. Experience in pharmaceutical pricing matters would similarly be highly valued.

• Key Responsibilities
  
  Commercial Legal Support & Brand Counseling
  
  
  • Serve as lead legal advisor to assigned rare disease brand(s), providing strategic and tactical legal counseling across all commercial activities
  
  
  
  • Advise on day-to-day sales and marketing initiatives, campaigns, and brand strategies in alignment with legal, regulatory, and compliance requirements
  
  
  
  • Support pre-launch and launch readiness activities, including development of promotional strategy, messaging frameworks, and commercialization plans
  
  
  
  • Assess legal risk associated with commercial strategies and communications, and recommend mitigation strategies
  
  
  
  • Develop and contribute to policies, procedures, and training related to advertising and promotion and commercial practices
  
  
  
  • Provide training to internal stakeholders on legal and compliance requirements
  
  
  Promotional Review & Advertising and Promotion
  
  Participate as a core member of promotional review committees, providing legal review and guidance for:
  
  
  • HCP and consumer promotional materials
  
  
  
  • Digital, print, and social media campaigns
  
  
  
  • Sales training and internal materials
  
  
  
  • Market access and payer communications
  
  
  
  • Patient support and disease awareness materials
  
  
  Rare Disease-Specific Counseling
  
  Advise on legal considerations unique to rare disease commercialization, including:
  
  
  • Small and highly targeted patient populations
  
  
  
  • Diagnostic challenges and patient identification strategies
  
  
  
  • High-touch patient and caregiver engagement models
  
  
  
  • Development of compliant approaches to disease awareness and education (prior to or independent of brand promotion), testing awareness, and patient journey messaging
  
  
  Regulatory & Compliance Advisory
  
  Counsel cross-functional stakeholders on applicable laws and regulations, including:
  
  
  • FDA advertising and promotion requirements and OPDP enforcement trends
  
  
  
  • Federal Anti-Kickback Statute, False Claims Act, and OIG guidance
  
  
  
  • FTC advertising and endorsement guidelines
  
  
  
  • PhRMA Code and industry standards
  
  
  
  • Relevant state laws governing commercial practices
  
  
  Commercial Programs & Engagement Models
  
  Provide legal guidance on a range of commercial tactics, including:
  
  
  • Speaker programs and advisory boards
  
  
  
  • Patient ambassador and testimonial programs
  
  
  
  • Influencer and digital engagement strategies
  
  
  
  • Copay programs, patient support services, and reimbursement communications
  
  
  
  • Sponsorships, grants, and market research activities

Qualifications

EDUCATION:

• Doctor of Jurisprudence (J.D.) or equivalent degree required
• Active membership in good standing in at least one U.S. state bar.

EXPERIENCE:

• Minimum of 5- 8 years of relevant experience as an attorney in the pharmaceutical or Biotech industry.
• Substantial experience advising on branded pharmaceutical promotional review and commercialization issues.

Knowledge and skills:

• Strong working knowledge of healthcare fraud and abuse laws, including the Anti-Kickback Statute, False Claims Act, and related enforcement risk areas.
• Familiarity with FDA requirements governing prescription drug promotion and labeling-related risk.
• Demonstrated ability to provide practical, business-oriented legal advice in a highly regulated and fast paced environment.
• Strong judgment, communication, and cross-functional collaboration skills.
• Experience & demonstrated ability to collaborate, build and sustain effective partnerships with multicultural key stakeholders and project teams
• Excellent written, verbal, and interpersonal communication skills.
• Ability to manage multiple priorities and work independently in a dynamic, cross-functional environment.

Highly Preferred Qualifications:

• Experience supporting product launches and commercialization activities strongly preferred

• Experience supporting rare disease products strongly preferred

• Experience interacting with FDA/OPDP on promotional matters

• Experience with specialty or complex therapeutic areas (e.g., neurology, genetic disorders)

• Familiarity with patient support programs, access and reimbursement considerations

• Experience supporting investigational or accelerated approval products

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
Empowered Development - Play an active role in professional development as a business imperative.

Minimum $186,489.00 - Maximum $278,875.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

Application Deadline: This will be posted for a minimum of 5 business days.

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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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.