Medical Director, Inflammation Clinical Science (Global)

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); Sur place; USD 237 000 - 373 000; Plein temps

Résumé du poste

Takeda in Cambridge, MA seeks a Medical Director, Clinical Science in the Inflammation TAU to provide medical leadership across global development programs. You will contribute to clinical strategy, study design, protocol development, medical monitoring and safety oversight, and the preparation of key regulatory documents.

You will work with cross-functional partners, interact with investigators and regulatory authorities, and drive decision-making on go/no-go, study modifications and labeling

Qualifications

• MD or internationally recognized equivalent plus 2 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned).
• Clinical or industry experience in Nephrology or Immunology preferred.
• Previous experience successfully leading matrix teams preferred.
• Management experience preferred.
• 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.
• Therapeutic area knowledge relevant to mechanisms of action of compounds in remit.
• 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.

Responsabilités

• Provides medical leadership for global development programs in the Inflammation TAU.
• Contributes to clinical development plans, protocol development, and regulatory submissions.
• Monitors safety and interprets data across ongoing studies, guiding go/no-go decisions and labeling considerations.
• Represents clinical science in cross-functional teams and external interactions with investigators and regulators.
• Leads and mentors clinical scientists, oversees study design and interpretation of results.
• Ensures scientific integrity and timely communication of study conclusions to management.

Connaissances

Clinical leadership

Regulatory strategy

Strategic planning

Cross-functional collaboration

Negotiation

Formation

MD or equivalent

Description du poste

Takeda in Cambridge, MA seeks a Medical Director, Clinical Science in the Inflammation TAU to provide medical leadership across global development programs. You will contribute to clinical strategy, study design, protocol development, medical monitoring and safety oversight, and the preparation of key regulatory documents.

You will work with cross-functional partners, interact with investigators and regulatory authorities, and drive decision-making on go/no-go, study modifications and labeling