Senior Director, Global Clinical Development
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Job Description
Senior Director leading global immunology clinical development at Otsuka, a healthcare and pharmaceutical company. Overseeing trials, regulatory submissions, CROs, and cross-functional study teams.
Responsibilities:
- Lead clinical development strategy and execution for assigned programs from proof of concept through late-stage trials and regulatory submissions
- Provide medical and scientific leadership to cross-functional study teams
- Ensure high-quality clinical trial design, conduct, and data interpretation
- Serve as medical lead and subject matter expert for assigned indications
- Ensure trials comply with GCP, regulatory requirements, and internal processes
- Lead and contribute to clinical sections of INDs, IBs, clinical study reports, and NDAs/BLAs
- Collaborate with regulatory affairs on interactions with global health authorities
- Provide strategic and medical oversight to vendor and CRO relationships and governance committees
- Lead clinical discussions with KOLs and advisory boards
- Develop medical monitoring plans and asset development plans
- Contribute to publication plans and review scientific manuscripts
- Mentor and provide leadership to junior team members
- Support business development through medical due diligence and evaluation of external opportunities
- Contribute to corporate continuous process improvement initiatives
Requirements:
- M.D. or D.O., preferably with an immunology, rheumatology, or dermatology background
- Management experience, direct or indirect
- Minimum of five years of clinical research experience post academia as a general guideline
- Experience in the pharmaceutical industry, clinical practice, and/or academic translational clinical research
- Thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines, including biostatistics, data management, and medical writing
- Advanced understanding of clinical medicine and science
- Advanced understanding of drug development principles and clinical trial implementation and management
- Complete understanding of global regulatory requirements
- Working knowledge of marketing and commercialization
- Understanding of corporate goals and basic business principles
- Demonstrated experience across developmental phases, including preclinical or in-licensing evaluation, early clinical safety and proof of concept, global registration trials, and late-stage life-cycle management
- Demonstrated experience leading clinical aspects of regulatory interactions
- Ability to work across therapeutic areas and stages of clinical development
- Demonstrated ability to manage and motivate clinical team members, internal staff, and external investigators/consultants
- Strong communication and presentation skills
- Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook
- Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing
- Travel approximately 30–35%
Benefits:
- Comprehensive medical, dental, vision, and prescription drug coverage
- Company-provided basic life insurance
- Accidental death and dismemberment insurance
- Short-term and long-term disability insurance
- Tuition reimbursement
- Student loan assistance
- Generous 401(k) match
- Flexible time off
- Paid holidays
- Paid leave programs
- Other company-provided benefits
- Incentive opportunity
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