Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) is an innovative, fast-growing healthcare company that discovers and develops new compounds that address unanswered medical needs and advance human health. With a strong focus on neuroscience, oncology, and cardio-renal treatments, OPDC is dedicated to improving the health and quality of human life. For more information, visit www.otsuka-us.com.
OPDC is a subsidiary of Otsuka America, Inc. (OAI), a holding company established in the U.S. in 1989. OAI is wholly owned by Otsuka Pharmaceutical Co., Ltd. The Otsuka Group employs approximately 42,000 people globally and its products are available in more than 80 countries worldwide. Otsuka welcomes you to visit its global website at https://www.otsuka.co.jp/en/.
Responsible for the design and oversight of clinical research programs and protocols for OPDC products. The incumbent will also be responsible for the clinical development of CNS compounds at different stages of development.
- Develops relationships with key opinion leaders and applies their input to enhance study design and protocols.
- Serves as a medical/scientific consultant to marketing, research project teams, and regulatory agencies.
- Establishes the conditions essential for determining the safety, efficacy, medical usefulness, and marketability of drug or medical device product candidates. Interprets results of Phase I-IV investigations in preparation for a new drug.
- Acts as the signatory on NDA submissions and clinical study and safety documents.
- Involved in product life cycle management.
- Oversees the CRO relationship, and provides input into the governance committee.
- Will help lead and support regulatory filing activities and documentsProvides input into ESP field monitor selection, as assigned. Reviews and approves CVs for ESP monitoring staff.
Performs other duties as assigned.
- M.D., preferably a psychiatrist, with at least 3-6 years of experience in the pharmaceutical industry.
- Prior Management Experience (direct or indirect) - 3 years (Associate Director); 6 years (Director).
- Requires thorough knowledge of clinical medicine and science management.
- Working knowledge of associated disciplines, including biostatistics, data management, and medical writing.
- An 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.
- Ability to work across different therapeutic areas and different stages of clinical development.
- Demonstrated experience in successful regulatory filings.
- Demonstrated ability to manage and motivate all clinical team members (e.g., internal staff and external investigators/consultants).
- Strong communication and presentation skills.
- Strong computer skills with demonstrated experience working in the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
- Knows how/when to apply organizational policy or procedures to a variety of situations.