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Director of Quality and Medical Staff

1 month ago

Princeton MN, United States Otsuka Full time

The Director role in Tuberculosis (TB) is part of the Global Clinical Development team at Otsuka and reports to the Senior Director, Global Clinical Development, OPDC.
In this role, you will, in general, support the Global Clinical Development team working on TB drug development in contributing to our trial activity and representing our phased clinical sciences activity in cross-functional teams.
This leadership role is integral to the team and supports the development team for TB assets in clinical development and the commercial team for ongoing surveillance and other activity in marketed TB products. You will provide clinical and scientific input as well as integrate in a variety of activities such as clinical operations, product development, novel diagnostic and biomarker expertise and contribute to clinical study development, implementation, and operational activity for TB assets in clinical development.
You will be responsible for the evaluation and development of TB products at different stages of clinical development for a global health-care market.
In this role, as needs arise, you may also be required to contribute your development expertise to other assets within the Nephrology, Immunology and Infectious Diseases Development Unit at Otsuka .
Consults with patients or their representatives, clinical, regulatory, and scientific leaders and thoughtfully applies their recommendations toward optimizing trial objectives, designs and protocols.
Develops focused expertise to serve as a clinical/medical scientific consultant to health economic, medical affairs, marketing, regulatory, statistical and other research project team members, and to external regulatory agencies.
GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.
Acts as the signatory on NDA submissions and clinical study and safety documents.
Involved in product life cycle management from the earliest stages of development, constantly seeking innovations to add value strategically.
Help lead and support regulatory filing activities and documents by providing strategic direction and editing to provide concise, clear, and convincing argumentation in all written and verbal communications.
Willingness to travel 30% of time, over weekends and ability to travel internationally.
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
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.
preferably an infectious diseases or TB background including prior management experience (direct or indirect). Experience in the pharmaceutical industry, clinical practice experience and/or academic translational clinical research experience in infectious diseases and specifically in TB will be a plus
A thorough knowledge of clinical medicine and science management. This entails defining critical objectives clearly and maintaining focus toward achieving business outcomes on time, on budget and with superior quality.
≥ 5 years of involvement in clinical research or drug development in an academic or industry environment across clinical activities in Phases I through IV.
This includes familiarity with the Microsoft suite of programs (Word, Excel, PowerPoint, and Outlook).
Demonstrated experience leading, managing, and motivating team members (e.g., internal staff and external investigators or consultants).
While not essential, prior personnel management experience will support position at entry.
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 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
Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
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.
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 your disability. Statement Regarding Job Recruiting Fraud Scams
ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
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Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. Please, no phone calls or emails.