Senior Medical Director, Clinical Science ,NS TAU- Sleep Medicine

About the role

The Senior Medical Director, Clinical Science Neuroscience, will lead and drive strategy for the global clinical development of assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues. They will lead a multi-disciplinary, multi-regional team through complex decisions, ensuring alignment with global strategy and maintaining a competitive, compliant development plan.

Responsibilities

• Leads Global Development Team, managing US/EU and Japan teams to ensure alignment with global strategy.
• Establishes and drives Development Team strategy and deliverables, including Development Strategy, Clinical Development Plan, and Clinical Protocols.
• Makes high-impact global decisions, interpreting data from studies and recommending changes to development plans or study designs.
• Drives clinical science activities, preparing synopses, protocols, and conducting studies, advising other clinical scientists.
• Manages medical monitoring activities, assessing protocol conduct and individual subject safety, and making final decisions on study conduct.
• Directs interactions with regulatory authorities and key opinion leaders, establishing strategy for assigned compounds and negotiating clinical development plans for potential alliances.
• Identifies and evaluates business development opportunities, conducts due diligence, and develops clinical development plans for potential alliances and in-licensing opportunities.
• Serves as clinical contact point for ongoing alliance projects, representing clinical science on internal assessment teams, and interfacing with partners to achieve Takeda's strategic goals.
• Hires, manages, mentors, motivates, empowers, develops, and retains staff to support assigned activities.

Requirements

• MD or internationally recognized equivalent with 7+ years of clinical research experience in the pharmaceutical industry, CRO, or academia.
• Previous experience leading a clinical development team/matrix team with responsibility for studies in multiple regions.
• NDA/MAA/Submission experience preferred.
• Management experience.

Skills

• Superior communication, strategic, interpersonal, and negotiating skills.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.

Education, Behavioural Competencies, and Skills

• MD or internationally recognized equivalent plus 7 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia.
• Therapeutic area knowledge relevant to mechanism of action, preferably with expertise in sleep medicine.
• Knowledge of regional/global regulatory requirements, GCP/ICH, and 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 15-25% travel.