Senior Director, Global Clinical Development CNS

Senior Director, Global Clinical Development

The purpose of this position is to lead the clinical development activities in support of domestic and international clinical development initiatives. The Senior Director, GCD works in a multidisciplinary matrix environment and supports the further development and commercialization of pharmaceutical products, for global launches. This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. The Senior Director, GCD is responsible for all the clinical development activities for the projects assigned and for the successful implementation and completion of trials leading to NDA and / or Global filings.

Key Job Responsibilities :

• Conceives, implements, and analyzes drug development programs, including :
• Understanding pharmacology of drugs and unmet medical needs.
• Formulating a rationale to develop the drug in accordance with a clinical and regulatory strategy.
• Working with experts and consultants in the field to refine a clinical development strategy.
• Designing clinical trials for the purpose of meeting specific objectives.
• Anticipating and addressing future commercial and clinical development needs, based on the clinical character of the compound.
• Implements clinical development programs, including :
• Co-authoring global clinical development plans with all practical elements.
• Leading and motivating the clinical development team to operationalize the clinical develop strategy, i.e., clinical trials management.
• Partnering with internal and external clinical experts and consultants to optimize the scientific integrity of the methodology and ensure the safety of clinical subjects.
• Leading clinical trial projects to ensure all aspects of the clinical trial project plan (e.g., enrollment, database lock) are achieved on time and with the highest quality.
• Developing and leading formal presentations of results to the medical community, in written, verbal, and visual formats.
• Analyzes and interprets the results of clinical programs in collaboration with clinical, biometric and clinical pharmacology experts.
• Partners with biostatistics, medical writers, and external consultants to understand and present the results of clinical development programs.
• Partners with internal decision makers to evaluate critical decision points.
• Acts as a signatory for the medical monitoring team.
• Contributes to corporate initiatives by participating in continuous process improvement to meet company objectives as well as evaluates in-licensing opportunities and / or additional life cycle management opportunities.
• Participates in NDA development, submission and defense.
• Lectures at national and international meetings, scientific advisory board meetings, and data safety monitoring boards.
• Mentors junior team members.

Knowledge, Skills, Competencies, Education, and Experience Required :

Physical Demands and Work Environment :

Travel (approximately 30%) See document Physical Demands and Work Environment for further requirements.

Competencies :

Salary Range : Minimum $245,454.00 - Maximum $381,110.00, plus incentive opportunity.

Company benefits : Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.

Otsuka is an equal opportunity employer. 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.