Director, Global Clinical Development

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 209,599 - 313,375; Full time

Benefits offered by this job

Comprehensive medical, dental, and vision coverage

Tuition reimbursement

Flexible time off

Generous 401(k) match

Job summary

A leading pharmaceutical company in the United States is seeking a Director of Global Clinical Development. This role involves consulting with patients and clinical leaders, overseeing clinical trials, and ensuring regulatory compliance. Candidates must have an M.D. or D.O. degree, preferably with a background in rheumatology, nephrology, or immunology, along with proven management experience. The position offers a competitive salary ranging from $209,599 to $313,375, along with comprehensive benefits including medical coverage and generous 401(k) matches.

Qualifications

• Must have a strong background in rheumatology, nephrology, or immunology.
• Experience in the pharmaceutical industry or translational clinical research required.
• Understanding of global regulatory requirements is essential.

Responsibilities

• Consult with patients, clinical, regulatory, and scientific leaders.
• Develop program strategies and oversee clinical trials.
• Lead and support regulatory filing activities.

Skills

Clinical knowledge

Management experience

Effective communication

Team leadership

Drug development principles

Flexibility in therapeutic areas

Education

M.D. or D.O. degree

Additional degrees (Ph.D., M.P.H., M.B.A.)

Tools

Microsoft Office Suite

Job description

Director, Global Clinical Development

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.
• Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
• Provides strategic oversight in vendor and CRO relationships, and provides clinical input into their governance committees.
• Will help lead and support regulatory filing activities and documents, providing strategic direction and editing to ensure concise, clear and convincing argumentation in all written and verbal communications.

Qualities and Required Qualifications

• A clinician (M.D. or D.O.) preferably with a rheumatology, nephrology or immunology background, and prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• Experience in the pharmaceutical industry or in academic translational clinical research (1-3 years for Associate Director level; 3-6 years for Director; 6-9 years for Senior Director depending on experience).
• A thorough knowledge of clinical medicine and science management, defining critical objectives and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.
• Ability to communicate effectively in meetings and via written and oral presentations, including proficiency with the Microsoft suite (Word, Excel, PowerPoint, Outlook).
• Demonstrated experience leading, managing and motivating team members (internal staff, external investigators, consultants). Prior personnel management experience is an advantage.
• Advanced understanding of drug development principles and clinical trial implementation, management and reporting.
• Flexibility in working across different therapeutic areas and stages of clinical development.
• Working knowledge of associated disciplines (biostatistics, clinical pharmacology, formulation science, data management, medical writing).
• Complete understanding of global regulatory requirements and successful regulatory filings.
• Working knowledge of health value creation principles, including financial assessment, project planning, budgeting, market research and commercialization strategies.
• Dedication to assigned projects and goals, appreciating corporate objectives in a compliant, regulated business setting.
• Willingness to travel 30% of the time, including weekends and internationally.

Competencies

• Accountability for Results – Stay focused on key strategic objectives, be accountable for high standards of performance, and lead change.
• Strategic Thinking & Problem Solving – Make decisions considering long‑term impact on customers, patients, employees and business.
• Patient & Customer Centricity – Maintain ongoing focus on their needs and key stakeholders.
• Impactful Communication – Communicate with logic, clarity and respect; influence at all levels.
• Respectful Collaboration – Seek and value others’ perspectives, fostering diverse partnerships.
• Empowered Development – Actively pursue professional development as a business imperative.

Compensation

Minimum $209,599.00 – Maximum $313,375.00, plus incentive opportunity. The range represents a typical pay range for this role in the United States; actual pay is based on experience, skills and internal comparison.

Application Deadline

This position 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; generous 401(k) match; flexible time off; paid holidays and paid leave programs; and other company‑provided benefits.

Disclaimer

This job description is intended to describe the general nature and level of the work performed by the position. It is not intended to include every duty and responsibility. Otsuka reserves the right to amend and change responsibilities as necessary.

Equal Opportunity Employer

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

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