Director, Global Clinical Development

Otsuka Pharmaceutical Co., Ltd.; United States; Remote; USD 210,000 - 313,000; Full time

Benefits offered by this job

Comprehensive medical

Dental

Vision

Prescription drug coverage

Life insurance

Disability insurance

Tuition reimbursement

Student loan assistance

401(k) match

Flexible time off

Paid holidays

Paid leave

Job summary

Otsuka Pharmaceutical Co., Ltd. seeks a Director, Global Clinical Development to design and oversee clinical programs for OPDC products, with options to work remotely or in Princeton, NJ, or Rockville, MD.

The role emphasizes collaboration with regulatory, medical affairs, and research teams to drive development strategies. The ideal candidate is an MD/DO with rheumatology/immunology/dermatology experience and 3–6 years in pharma or translational research, capable of leading diverse teams and

Qualifications

• MD/DO with rheumatology, nephrology, immunology or dermatology background; prior management experience is a plus.
• 3–6 years in pharma or translational clinical research.
• Strong understanding of clinical medicine and project management to deliver on time and budget.

Responsibilities

• Designs and oversees clinical research programs and protocols under GCP.
• Serves as internal medical/scientific consultant to cross-functional teams and external regulatory bodies.
• Authors program strategies and oversees trials to determine safety, efficacy, and value of products.
• Interprets Phase I–IV results for regulatory submissions and development decisions.
• Provides oversight of vendor/CRO relationships and governance inputs.
• Supports regulatory filing activities and contributes to clear, persuasive communications.

Skills

Clinical development

GCP

Regulatory filings

Team leadership

Medical affairs

Education

MD/DO (Rheumatology/Immunology/ Dermatology)

PhD / MPH / MBA (plus)

Tools

MS Office

Job description

Detailed Description of Duties:

• Otsuka is seeking a Director, Global Clinical Development (GCD) based Remotely or in our Princeton, NJ or Rockville, MD offices, who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The incumbent will be responsible for the evaluation and clinical development of Rheumatology, Immunology and Specialty Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Associate Director/Director/Senior Director, Global Clinical Development include the following:
• 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 our 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 provide concise, clear and convincing argumentation in all such written and verbal communications.

Detailed Description of Required Qualifications:

• A clinician (M.D., or D.O.) preferably a rheumatology, nephrology, immunology or dermatology background, 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.
• 3-6 years of experience in the pharmaceutical industry or in academic translational clinical research.
• A thorough knowledge of clinical medicine and science management. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.
• An ability to communicate effectively in meetings and via written and oral presentations is essential. This includes facility with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
• Demonstrated experience leading, managing and motivating team members (e.g., internal staff and external investigators or consultants). While not essential, prior personnel management experience, will support position at entry (Associate Director/Director/Senior Director).
• An advanced understanding of drug development principles and clinical trial implementation, management and reporting is essential and will be further developed, including:
• Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
• Working knowledge of associated disciplines, including biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
• Complete understanding of the global regulatory requirements. Demonstrated experience in successful regulatory filings, while not essential, is an advantage.
• Working knowledge of the principles of health value creation, including financial assessment (e.g., net present value), project planning and budgeting, market research and commercialization strategies.
• Dedication to assigned, developed projects and project goals. This includes an appreciation of the principles applied in setting and achieving corporate goals through matrixed teamwork in a compliant, regulated business setting.
• Willingness to travel 30% of time, over weekends and ability to travel internationally.

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 $209,599.00 - Maximum $313,375.00, 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
• paid leave programs as well as other company provided benefits

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 [e-mail].