Otsuka Pharmaceutical Companies (U.S.) · 4 hours ago
Senior Director, Global Clinical Development – Nephrology & Immunology
United States
Full-time
Remote
Lead/Staff, Director/Executive
$245K/yr - $381K/yr
5+ years expOtsuka Pharmaceutical Companies is a global healthcare company focused on innovative pharmaceutical and nutraceutical products. The Senior Director, Global Clinical Development will lead the design, execution, and oversight of global clinical development programs in immunology, ensuring the highest standards of scientific and medical integrity while guiding cross-functional teams.
Health CareMedical
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 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
Qualification
Required
A clinician (M.D., or D.O.) preferably with an immunology, rheumatology, or dermatology background including 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
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 (e.g. biostatistics, data management, medical writing)
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 (e.g., internal staff and external investigators/consultants)
Strong communication and presentation skills
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook)
Knows how/when to apply organizational policy or procedures to a variety of situations
An advanced understanding of drug development principles and clinical trial implementation, management and reporting are 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 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
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
Other company provided benefits
Company
Otsuka Pharmaceutical Companies (U.S.)
There are two Otsuka pharmaceutical industry companies in the U.S.: Otsuka America Pharmaceutical, Inc.
1001-5000 employees
H1B Sponsorship
Otsuka Pharmaceutical Companies (U.S.) has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2024 (6)
2023 (11)
2022 (5)
2021 (9)
2020 (13)
Funding
Current Stage
Late StageLeadership Team
Tarek Rabah
President & CEO
Reza Moghadam
Co-founder and lead for PsychU (www.PsychU.org)
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