Director, Global Clinical Development - Tuberculosis

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 design and oversight of clinical research programs and protocols for Otsuka TB products under good clinical practices (GCP). 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. 

Required

Duties:

• 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.

• Authors program strategies (i.e., GDCP) and oversees trials essential for determining the clinical safety, efficacy, medical usefulness and value of drug or medical device product candidates.

• Interprets and communicates 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 from the earliest stages of development, constantly seeking innovations to add value strategically.

• Provides strategic oversight in our vendor and CRO relationships and provides clinical input into their governance committees and operational activities.

• 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.

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