Senior Director, Global Clinical Development – Nephrology & Immunology

Senior Director, Global Clinical Development (GCD)

Otsuka is a global healthcare company with the corporate philosophy: "Otsuka people creating new products for better health worldwide." Otsuka researches, develops, manufactures, and markets innovative products, with a focus on pharmaceutical products for the treatment of diseases and nutraceutical products for maintenance of everyday health. In pharmaceuticals, Otsuka focuses on the development and commercialization of therapies in the challenging areas of Neuroscience, Nephrology, and Immunology in addition to research programs in various unmet specialty disease areas.

Otsuka is seeking an experienced and visionary Senior Director, Global Clinical Development (GCD), with experience in immunology, who will serve as a clinical leader responsible for the design, execution, and oversight of global clinical development programs. The successful candidate will play a key role in shaping the clinical strategy, leading cross-functional study teams, and ensuring the highest standards of scientific and medical integrity. The incumbent will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization, with emphasis on the large global clinical trials and regulatory filing activities.

Key Job Responsibilities:

• Lead the clinical development strategy and execution for assigned programs after 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 team to ensure trials are conducted in compliance with the GCP, regulatory requirements, and internal processes.
• Lead and contribute to development of clinical sections of regulatory documents, including INDs, IBs, clinical study reports, and NDAs/BLAs.
• Collaborate with regulatory affairs on interactions with global health authorities.
• Provides strategic and medical oversight to vendor and CRO relationships and provides clinical input into their governance committees.
• Lead clinical discussions with KOLs and advisory boards.
• Develop clinical documents including medical monitoring plans, asset development plans.
• Contribute to development of publication plans and review scientific manuscripts for publications.
• Mentor and provide leadership to junior team members within the organization.
• Support business development activities through medical due diligence and evaluation of external opportunities.
• Contributes to corporate initiatives by participating in continuous process improvement to meet company goals.

Knowledge, Skills, Competencies, Education, and Experience:

• A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including management experience.
• Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline minimum of five years of clinical research experience, post academia).
• Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines.
• An advanced understanding of clinical medicine and science.
• Advanced understanding of drug development principles and clinical trial implementation and management.
• Complete understanding of the global regulatory requirements.
• Working knowledge of marketing and commercialization.
• Complete understanding of overall corporate goals with a fundamental grasp of basic principles to work in a business setting.
• Demonstrated experience in all developmental phases including evaluation of pre-clinical or in-licensing candidates' potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies.
• Demonstrated experience in successfully leading clinical aspects of regulatory interactions; experience with a successful regulatory filing is a plus.
• Ability to work across different therapeutic areas and different stages of clinical development.
• Demonstrated ability to manage and motivate clinical team members.
• Strong communication and presentation skills.
• Strong computer skills with demonstrated experience in working with the Microsoft suite of programs.
• An advanced understanding of drug development principles and clinical trial implementation, management and reporting are essential and will be further developed.
• Flexibility in working across different therapeutic areas and experience in different stages of clinical development.
• Working knowledge of associated disciplines, including immunology, 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.

Physical Demands and Work Environment:

• Travel (~30-35%)

Competencies:

• Accountability for Results
• Strategic Thinking & Problem Solving
• Patient & Customer Centricity
• Impactful Communication
• Respectful Collaboration
• Empowered Development

Salary Range: Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity.

Application Deadline: This will be posted for a minimum of 5 business days.

Company benefits include 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, and 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 Accommodation Request.

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