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 proud of its distinct culture that provides a competitive advantage. At Otsuka, we defy limitation, so that others can too, an attribute that reflects its Japanese heritage. Sozosei, meaning "creativity", gives Otsuka people permission to do what's never been done and can only be done by Otsuka. Every day is a new chance to invent and to create so that we can provide answers to medical needs that have yet to be addressed. Another Japanese tenet, Jissho-Shugi, means "earning responsibility by proving that you can deliver results consistently. Prove what you can do with small responsibilities and then move on to bigger responsibilities." Otsuka people are encouraged to push themselves far beyond expectations. To dream the impossible and make it a reality. By living the principles of Jissho (self-actualization), individuals and teams can achieve unprecedented outcomes that ultimately lead to greater responsibility.

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. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA, BLA, and/or Global filings.

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 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

Knowledge, Skills, Competencies, Education, and Experience:

• 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.

Physical Demands and Work Environment:

• Travel (~30-35%)

Competencies:

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.

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

Company 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, 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