Senior Director, Global Clinical Development – Nephrology & Immunology
About The Position
Otsuka is seeking an experienced clinical leader with immunology experience to direct global clinical development strategy across multiple programs. The Senior Director will shape clinical strategy, lead cross-functional study teams, and uphold scientific and medical integrity while overseeing the design and conduct of clinical research programs and protocols for OPDC products in accordance with good clinical practices (GCP). Working in a multidisciplinary matrix environment, this role supports the further development and commercialization of pharmaceutical products for global launches. It requires a deep understanding of drug development from early clinical stages through post-commercialization, with particular emphasis on large global trials and regulatory filings. The Senior Director is accountable for clinical development activities for assigned projects and for implementing and completing trials that lead to NDA, BLA, and/or global filings.
Requirements
- M.D. or D.O., preferably with an immunology, rheumatology, or dermatology background, and direct or indirect management experience.
- At least five years of clinical research experience as a general guideline, post-academia; pharmaceutical industry, clinical practice, and/or academic translational clinical research experience.
- 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.
- Experience evaluating preclinical or in-licensing candidates for unmet medical needs, establishing early clinical safety and proof of concept, conducting global registration trials, and implementing late-stage lifecycle management strategies.
- Experience successfully 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, including internal staff and external investigators or consultants.
- Strong communication and presentation skills.
- Strong computer skills and demonstrated experience with Microsoft Word, Excel, PowerPoint, and Outlook.
- Ability to apply organizational policies and procedures appropriately in varied situations.
- Willingness to travel approximately 30–35%.
Nice To Haves
- Supplementary degree such as a Ph.D., M.P.H., or M.B.A.
- In exceptional circumstances, a highly qualified candidate with another clinical or scientific doctorate (such as 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.
- Successful regulatory filing experience.
- Working knowledge of immunology, biostatistics, clinical pharmacology, formulation science, data management, and medical writing.
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 and ensure high-quality clinical trial design, conduct, and data interpretation.
- Serve as the medical lead and subject matter expert for assigned indications.
- Partner with cross-functional teams to ensure trials comply with GCP, regulatory requirements, and internal processes.
- Lead and contribute to clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
- Collaborate with regulatory affairs on interactions with global health authorities.
- Provide strategic and medical oversight of vendor and CRO relationships and contribute clinical input to their governance committees.
- Lead clinical discussions with KOLs and advisory boards.
- Develop clinical documents, including medical monitoring plans and asset development plans.
- Contribute to publication plans and review scientific manuscripts for publication.
- Mentor and provide leadership to junior team members.
- Support business development through medical due diligence and evaluation of external opportunities.
- Participate in continuous process improvement and corporate initiatives.
Benefits
- Comprehensive medical, dental, vision, and prescription drug coverage.
- Company-provided basic life insurance and accidental death and dismemberment coverage.
- 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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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
