Clinical Operations/Study Management, Executive Leader, Medical Operations
Supports Vice President, U.S. Medical Affairs. Responsible for all medical affairs activities associated with the development and commercialization of branded neuroscience products in the U.S. Responsibilities include collaborating across commercial, clinical and field medical teams. Acts as a driving force in the public dissemination of information and data, both internally and externally. Provides input on product labeling and promotional materials.
Product commercialization and evidence generation
Work with commercial and clinical development colleagues to support marketed products as well as life cycle management
Serve as a member of the development and brand teams for Otsuka products.
Leads team that develops, produces, and organizes manuscripts, presentations and posters at congresses
Interacts with experts in the field to obtain feedback on products.
Leads team that provides medical input into the creation of marketing materials and ensures data is accurately and effectively communicated, including review of all promotional materials.
Provides input into regulatory documents.
Supports the execution of medical affairs plan for Otsuka products
Participates in extramural conferences and scientific meetings to maintain awareness of research in the field.
Manages and executes Phase 3b & 4 studies as needed
Reviews Investigator Sponsored Trials as needed
Review grant requests as needed
Provide content resources to Field Medical Affairs consistent to Medical Affairs strategy
Coordinates with sales management to provide training to sales staff.
Keeps abreast of current state-of-the-art developments relating to in-house medical program focus, and provides education to project team members, as needed.
Serves as a source of medical expertise on Otsuka clinical trials for in-house customers.
Requires extensive understanding of the company's products, commercialization strategy, the competition, and the pharmaceutical industry in general.
MD or PhD required.
Minimum of 6 years of experience in the pharmaceutical industry.
Experience in psychiatry and/or neuroscience
Maintains a current awareness of new drug developments in targeted therapeutic areas.
Strong scientific background and solid understanding of the pre-clinical and clinical development processes.
Solid statistical knowledge with a demonstrated ability to interpret study findings and communicate appropriately.
Good knowledge of OPDP promotional regulations and pharmaceutical promotion standards
Good knowledge of CDER/CBER regulations regarding evaluation and approval of pharmaceuticals
Understanding of US pharmaceutical safety reporting and surveillance
Ability to interpret scientific data
Skilled in managing and influencing people
Strong computer skills with demonstrated experience in working with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Demonstrated experience working with secondary data sources.
Demonstrated ability to effectively communicate (written information and presentations) with internal and external parties.
Familiarity with Biostatistics and clinical study operations and execution
Excellent communication and interpersonal skills
Physical Demands and Work Environment
Travel 25 – 30% (domestic and/or global) upon return to normal business activities
Internal Number: R134
About Otsuka America Pharmaceutical, Inc.
At Otsuka, we defy limitation, so that others can too.
We have an unwavering belief in doing more. In transcending expectations. In going above and beyond—under any circumstances—for patients, families, providers, and for each other. It’s this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.
Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho – the achievement, completion, and discovery of truth; and Sozosei – pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.
Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com