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. They make high-impact global decisions, interpret data, and interact with senior leadership to set strategic direction.

Responsibilities

• Leads Global Development Team for a given product, aligning activities with global strategy.
• Establishes and drives Development Team strategy and deliverables, producing Development Strategy, Clinical Development Plan, and Clinical Protocols.
• Monitors and interprets data from ongoing internal and external studies, assessing medical and scientific implications, and making recommendations that impact regional and global development.
• Drives clinical science activities, including synopsis and protocol development, study execution, and study interpretation.
• Interprets data from an overall scientific standpoint and within the context of medical significance to individual patients.
• Responsible for medical monitoring activities, assessing protocol conduct and individual subject safety, and overseeing non-medical clinical scientists.
• Makes final decisions regarding study conduct related to scientific integrity.
• Directs activities involving interactions with regulatory authorities and key opinion leaders, establishing and maintaining strong relationships.
• Identifies and evaluates potential business development opportunities, conducts due diligence evaluations, and develops and negotiates clinical development plans for potential alliances and in-licensing opportunities.
• Serves as clinical contact point for ongoing alliance projects and interfaces with partners to achieve Takeda's strategic goals.
• Interacts with Neuroscience Drug Discovery Unit and Business Units to provide knowledge and understanding of market environments, serving as a R&D scientific content matter expert for assigned compounds.
• Represents clinical science on multidisciplinary task forces across divisions, leading R&D internal teams and global cross-functional teams as appropriate.

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.

Skills

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

Knowledge

• Therapeutic area knowledge relevant to mechanism of action.
• Expertise in psychiatry.
• Regional/global regulatory requirements.
• GCP/ICH.
• Emerging research in designated therapeutic area.

Travel Requirements

Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Approximately 10-20% travel.

Compensation and Benefits

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, with new hires accruing up to 120 hours of paid vacation.

EEO Statement

Takeda is committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.