Medical Director, Clinical Science, Neuroscience TAU- Psychiatry

About the role

The Medical Director leads and drives strategy for the overall global clinical development of assigned Takeda pipeline compounds. They lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions, ensuring alignment with global strategy. This individual has ultimate responsibility for development decisions, assessing and integrating input from various disciplines to create, maintain, and execute a global clinical development plan.

Responsibilities

• Leads Global Development Team for a given product, representing Clinical Science on the Global Development Team to ensure activities align with the global strategy.
• Establishes and drives Development Team strategy and deliverables, producing the Development Strategy, Clinical Development Plan, and Clinical Protocols. Influences the scope, complexity, and size of all aspects of a program and continually evaluates the development strategy to maintain a state-of-the-art plan.
• Makes high-impact global decisions, interpreting data from ongoing internal and external studies, assessing medical and scientific implications, and recommending actions that impact regional and global development, such as "go/no go" decisions or modifications to development plans or study designs.
• Drives clinical science activities, including synopsis and protocol development, study execution, and study interpretation. Serves as an advisor to other clinical scientists and is accountable for the successful design and interpretation of clinical studies.
• Interprets data from an overall scientific standpoint and within the context of medical significance to individual patients. Oversees medical monitoring activities, assesses issues related to protocol conduct and/or individual subject safety, and makes final decisions regarding study conduct related to scientific integrity.
• Directs activities involving interactions with regulatory authorities and clinical development activities to establish and maintain strong relationships with key opinion leaders relevant to assigned compounds and therapeutic areas. Directs activities involved in due diligence evaluations, development and negotiation of clinical development plans for potential alliances and/or in-licensing opportunities.
• Serves as a clinical contact point for ongoing alliance projects and interfaces with partners to achieve Takeda's strategic goals while maintaining good working relationships.
• Interacts with Neuroscience Drug Discovery Unit and Business Units to provide knowledge and understanding of the market environment, serving as a R&D scientific content matter expert for assigned compounds. Represents clinical science on multidisciplinary task forces across divisions.

Requirements

MD or internationally recognized equivalent with 5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia. Previous experience successfully leading a clinical development team/matrix team with responsibility for phase 3 clinical studies in multiple regions. NDA/MAA/Submission experience preferred. Management experience.

Qualifications

• Superior communication, strategic, interpersonal, and negotiating skills.
• Proactive issue prediction and problem-solving abilities.
• Strong decision-making capabilities within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.

Skills

• Therapeutic area knowledge relevant to mechanism of action, with expertise in psychiatry.
• Expertise in regional/global regulatory requirements, GCP/ICH, and emerging research in designated therapeutic areas.

Benefits

Takeda offers a comprehensive benefits package including:

• U.S. Base Salary Range: $237,200.00 - $372,790.00
• Short-term and long-term incentives.
• Medical, dental, vision insurance.
• 401(k) plan and company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per year.
• New hires eligible for up to 120 hours of paid vacation.

Pay

Base salary range: $237,200.00 - $372,790.00

Schedule

Hybrid work model with some international travel required.