Associate Medical Director, Clinical Science, GI2 TAU

Job Description Apply as an Associate Medical Director, Clinical Science, GI2 TAU in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D‑driven market leadership. We are a values‑led company, certified as a Global Top Employer, and we foster an inclusive, collaborative workplace united by a commitment to deliver Better Health and a Brighter Future to people worldwide. Here, you will be a vital contributor to our inspiring, bold mission. Accountabilities Represents Clinical Science on Project or Clinical Teams and may serve as the Clinical Science leader on these teams. Supports the Global Project Team to ensure that the clinical team activities are aligned with the global strategy. Contributes to the overall Asset Strategy by supporting the development of the Clinical Development Plan, leads the development of Clinical Protocols and other documents needed for CDP and study execution and regulatory submissions. Recommends scope, complexity and size, and influences the budget of all aspects of a study. Ongoing work output involves continual critical evaluation of the development strategy to maintain a state‑of‑the‑art development plan competitively consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Recommends high‑impact global decisions. Responsible for monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications, and making recommendations that impact regional and global development such as go/no‑go decisions or modifications of development plans or study designs that may have significant impact on timelines or product labeling. Synopsis / Protocol Development, Study Execution, & Study Interpretation Oversees Clinical Science department activities concerning the preparation/approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists and is accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy. Interprets data from an overall scientific standpoint as well as within the context of medical significance to individual patients. Trial Medical Monitoring Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compound in conjunction with Pharmacovigilance. Oversees non‑medical clinical scientists with respect to assessment of these issues. Makes final decisions regarding study conduct related to scientific integrity. External Interactions Directs interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Provides leadership in meetings and negotiations with key opinion leaders, establishes strategy for assigned compounds, and directs clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications. Leads incorporation of advice/recommendations received into the design of clinical studies and programs as appropriate. Due Diligence, Business Development and Alliance Projects Responsible for evaluation of potential business development opportunities, conducts due diligence evaluating scientific, medical, and development feasibility, evaluating ongoing clinical trials, assessing regulatory interactions and future development plans. For alliance projects, will interface with partner to achieve Takeda’s strategic goals while maintaining a good working relationship. Leadership, Task Force Participation, Upper Management Accountability Interacts directly with research division based on pertinent clinical and development expertise. Represents clinical science on high‑impact/priority task forces across the organization or externally. Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Education, Experience, Knowledge and Skills MD or internationally recognized equivalent plus 3 years of clinical research experience in the pharmaceutical industry, a CRO, health‑related consulting company, or biomedical/clinical academia (or a combination). Subspecialty in Hepatology or Immunology highly preferred. Experience and knowledge of alpha‑1 antitrypsin deficiency a plus. Phase 3 clinical trial experience preferred. Previous experience successfully leading matrix teams preferred. Management experience preferred. 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 team. Diplomacy and positive influencing abilities. Knowledge Therapeutic area knowledge relevant to mechanisms of action of compounds in remit. Regional/global regulatory requirements. GCP/ICH guidelines. Emerging research in designated therapeutic area. Travel Requirements Ability to drive or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 15‑25% travel. Takeda Compensation and Benefits Summary For Location: USA – MA – Cambridge U.S. Base Salary Range: $198,500.00 – $311,850.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the applicant, years of relevant experience, specific skills, level of education, certifications, and location. U.S. based employees may be eligible for short‑term and/or long‑term incentives, medical, dental, vision insurance, a 401(k) plan with company match, short‑term and long‑term disability coverage, basic life insurance, tuition reimbursement, paid volunteer time off, company holidays, and wellbeing benefits. U.S. based employees are eligible to receive, per calendar year, up to 80 hours of sick time, and new hires accrue up to 120 hours of paid vacation. 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.