Associate Medical Director, Clinical Science, NS TAU- Neurology/Psychiatry

Job Description Associate Medical Director in Neuroscience Therapeutic Area Unit, Cambridge, MA. Position Objectives The Associate Medical Director leads and drives strategy for clinical studies within global clinical development for assigned Takeda pipeline compounds, considering medical, scientific, regulatory, and commercial issues. Leads or joins multi-disciplinary, multi-regional, matrix teams, making development decisions and integrating input from various disciplines to create and execute studies within a clinical development plan resulting in regulatory approval in multiple regions. Interacts with and influences Neuroscience Therapeutic Area Unit senior leadership by contributing to strategic direction. Success or failure directly translates to the ability of R&D to meet corporate goals and for Takeda to have future commercial products. Accountabilities Clinical team participation and leadership Represents Clinical Science on Study Execution and Clinical Teams and may serve as co-leader of these teams. Supports the Global Project Team to ensure alignment with global strategy. May act as Global Clinical Lead for early or smaller scope products. Contributes to global project and clinical team strategy, deliverables, asset strategy, clinical development plan, clinical protocols, recommending scope, complexity, size and budget, and maintains a state‑of‑the‑art development plan. Monitors and interprets data from ongoing studies, assessing medical and scientific implications and making recommendations impacting regional and global development decisions. Synopsis / Protocol Development, Study Execution, & Study Interpretation Oversees all Clinical Science activities for the preparation/approval of synopses, protocols, and conduct of clinical studies. Interprets data from a scientific standpoint, presenting conclusions to management and determining impact on overall compound strategy. Trial Medical Monitoring Responsible for medical monitoring activities, assessing protocol conduct and subject safety. Assesses overall safety information with Pharmacovigilance. Oversees non‑medical clinical scientists on assessment issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions Directs interactions with key opinion leaders relevant to assigned compounds. Leads meetings and negotiations with key opinion leaders, establishing strategy for assigned compounds and leading clinical scientists in development of documents and responses to regulatory agencies. Incorporates advice into the design of clinical studies and programs. Due Diligence, Business Development and Alliance Projects Evaluates potential business development opportunities and conducts due diligence assessments of scientific, medical and development feasibility. Contributes to negotiation of clinical development plans for potential alliances, interfaces with partners and maintains relationships. Leadership, Task Force Participation, Upper Management Accountability Provides clinical science expertise to research division and other functions. Represents clinical science and leads internal task forces and therapeutic area internal teams. Mentors, motivates, empowers, develops and retains staff. Education, Experience, Knowledge and Skills Education and experience MD or internationally recognized equivalent plus 3 years of clinical research experience in pharmaceutical industry, CRO, consulting, or academia. Previous experience successfully leading matrix teams preferred. Skills Superior communication, strategic, interpersonal and negotiating skills. Ability to proactively predict issues and solve problems. Ability to drive decision‑making within multi‑disciplinary, multi‑regional, matrix teams. Diplomacy and positive influencing abilities. Knowledge Specialization in Neurology or Psychiatry preferred. Regional/global regulatory requirements.

GCP/ICH.

Travel Requirements Ability to drive or fly to meetings or client sites, including overnight trips. Some international travel may be required, approximately 10–20% travel. Position classified as “hybrid”. EEO Statement Takeda is proud in its commitment 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. #J-18808-Ljbffr Initial Therapeutics, Inc.