Company Background/Culture
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.
Culture
As a Company with a rich 100-year history, 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.
Pipeline
Since 2007, OPDC has dedicated itself to the research and clinical development of products that could have a major impact on human health. OPDC develops promising drug candidates, starting with clinical trial management, and then planning the strategy for drug approval, and life cycle management to maximize a product’s full potential. There are numerous compounds currently in the pipeline. In conjunction with Otsuka America Pharmaceutical, Inc., (OAPI), Otsuka has global strategies in place for the registration of their products.
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Job Description
Position Summary
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
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.
Physical Demands and Work Environment
- Travel (~30-35%)
- See document Physical Demands and Work Environment for further requirements.
