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.

Competencies:

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.

• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.

• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.

• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.

• 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.

Qualifications:

• A clinician (M.D., or D.O.) preferably an infectious diseases or TB background including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus.

• 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.

• An ability to communicate effectively in meetings and via written and oral presentations is essential. 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

#LI-Remo

Competencies
Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
Impactful Communication -Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
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.

Company benefits: comprehensive medical, dental, vision and prescription drug coverage, company provided Basic Life, AD&D, Short-term and Long-term Disability insurance, tuition reimbursement, a 401(k) match, PTO allotment each calendar year, paid holidays, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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