Director, Global Clinical Development-Rheumatology and Immunology

Job Description

Otsuka is seeking a Director, Global Clinical Development (GCD), who will be responsible for the design and oversight of clinical research programs and protocols for OPDC products under good clinical practices (GCP). This is a remote position.

The incumbent will be responsible for the evaluation and clinical development of Rheumatology, Immunology and Specialty Medicine products at different stages of development for a global health-care market. The specific duties assigned to the Director, Global Clinical Development include the following:

• 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 an 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.
• Will help lead and support regulatory filing activities and documents. Providing strategic direction and editing to provide concise, clear, and convincing argumentation in all written and verbal communications.

Qualifications

Required

• A clinician (M.D., or D.O.) preferably a rheumatology / immunology background including prior management experience (direct or indirect). Supplementary degrees (e.g., Ph.D., M.P.H., M.B.A.) are a plus. In exceptional circumstances, highly qualified candidates with other clinical/scientific doctorates (e.g. D.M.D., D.D.S., Pharm.D., Psy.D., D.V.M., or Ph.D. may be considered if complemented by a team or consulting clinician.
• Experience in the pharmaceutical industry, clinical practice experience and/o academic translational clinical research experience (as a general guideline, 1-3 years for Associate Director level; 3-6 years for Director and 6-9 years is typically required depending on type of experience at application).
• 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 facility 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 (Associate Director/Director).
• 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 immunology, 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.

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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