Director, Global Clinical Development

Otsuka Pharmaceutical Co., Ltd.; United States; On-site; USD 209,599 - 313,375; Full time

Benefits offered by this job

Comprehensive medical, dental, vision coverage

401(k) match

Tuition reimbursement

Flexible time off

Job summary

Otsuka Pharmaceutical Development & Commercialization, Inc. is seeking a Medical Director to oversee clinical trial objectives and strategies. The ideal candidate will have extensive experience in the pharmaceutical industry, preferably as a clinician. Responsibilities include leading regulatory filings, consulting with stakeholders, and ensuring compliance in a regulated environment.

This role offers a competitive salary of $209,599.00 – $313,375.00 plus incentives, along with comprehensive benefits like medical coverage, disability insurance, and a 401(k) match.

Qualifications

• At least 6 years of experience in the pharmaceutical industry or translational clinical research.
• Knowledge of health value creation principles including budgeting and assessment.
• Willingness to travel 30% of the time, including weekends.

Responsibilities

• Consult with patients, regulatory leaders to optimize trial objectives.
• Lead regulatory filing activities and document strategic direction.
• Provide oversight of vendor relationships and governance committees.

Skills

Clinical consultation

Excellent communication skills

Team leadership

Drug development principles

Regulatory knowledge

Education

M.D. or D.O.

Supplementary degrees (Ph.D., M.B.A.)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Job description

Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is a U.S. subsidiary of Otsuka Pharmaceutical Co. Its Global Clinical Development (GCD) department collaborates with physicians and scientists to lead the global clinical development activities for Otsuka’s health‑care products.

Responsibilities

• Consult with patients or their representatives, clinical, regulatory and scientific leaders to optimize trial objectives, designs and protocols.
• Serve as an internal medical/scientific consultant for health economics, medical affairs, marketing, regulatory, statistical and other research project teams, and for external regulatory agencies.
• Author program strategies (e.g., GDCP) and oversee trials essential for determining clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
• Interpret and communicate results of Phase I–IV investigations in preparation for a new drug.
• Act as the signatory on NDA submissions and clinical study and safety documents.
• Participate in product life‑cycle management from the earliest stages of development, continuously seeking innovations to add strategic value.
• Provide strategic oversight of vendor and CRO relationships and clinical input into their governance committees.
• Lead and support regulatory filing activities and documents, providing strategic direction and editing to create concise, clear and convincing argumentation in all written and verbal communication.

Basic Qualifications

• Clinician (M.D., D.O.) preferably a psychiatrist or neurologist with prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.
• Highly qualified candidates with other clinical or scientific doctorates (e.g., D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., Ph.D.) considered if complemented by a team or consulting clinician.
• Minimum 6 years of experience in the pharmaceutical industry or academic translational clinical research.

Preferred Qualifications

• Thorough knowledge of clinical medicine and science management, including defining critical objectives and maintaining focus on business outcomes.
• Excellent communication skills, both in meetings and in written and oral presentations; proficiency with Microsoft Word, Excel, PowerPoint, Outlook.
• Demonstrated experience leading, managing and motivating teams (internal staff and external investigators or consultants).
• Advanced understanding of drug development principles and clinical trial implementation, management and reporting.
• Flexibility across therapeutic areas and stages of clinical development.
• Working knowledge of biostatistics, clinical pharmacology, formulation science, data management and medical writing.
• Complete understanding of global regulatory requirements and prior experience in regulatory filings.
• Knowledge of health value creation principles, including financial assessment, project planning, budgeting and commercialization strategies.
• Dedication to assigned projects and ability to work in a compliant, regulated business setting with matrixed teamwork.
• Willingness to travel 30% of the time, including weekends and international travel.

Competencies

• Accountability for results: Stay focused on key strategic objectives and take an active role in leading change.
• Strategic thinking & problem solving: Make decisions that consider long‑term impact on customers, patients, employees and the business.
• Patient & customer centricity: Maintain an ongoing focus on the needs of our customers and key stakeholders.
• Impactful communication: Communicate with logic, clarity and respect; influence at all levels.
• Respectful collaboration: Seek and value others' perspectives and foster diverse partnerships.
• Empowered development: Actively support professional development as a business imperative.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company‑provided basic life, accidental death & dismemberment, short‑term and long‑term disability insurance.
• Tuition reimbursement and student loan assistance.
• Generous 401(k) match, flexible time off, paid holidays and paid leave programs.

Pay Range

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

Equal Opportunity Employer

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.