Associate Medical Director, Clinical Science, NS TAU

Associate Medical Director

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Medical Director in our Neuroscience Therapeutic Area Unit in our Cambridge, MA office.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Here, you will be a vital contributor to our inspiring, bold mission.

POSITION OBJECTIVES:

• The Associate Medical Director leads and drives strategy for clinical studies within the overall global clinical development for assigned Takeda pipeline compound(s) taking into consideration the medical, scientific, regulatory and commercial issues.
• Leads or joins multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute studies within a clinical development plan that will result in the regulatory approval of the compound in multiple regions. Applies clinical/medical decision making to clinical development issues.
• This individual interacts with and influences Neuroscience Therapeutic Area Unit senior leadership decision-making by contributing to strategic direction.
• Success or failure directly translates to the ability of R&D to meet its 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 that the clinical team activities are aligned with the global strategy.
• May act as Global Clinical Lead for an early clinical stage or preclinical program with significant interactions with translational and biomarker colleagues, and preclinical teams.
• Contributes to Global Project and clinical team strategy and deliverables working on the Asset Strategy, Clinical Development Plan, Clinical Protocols and other documents needed for study execution. Recommends scope, complexity and size, and influences the budget of all aspects of a study or program. Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and 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 modification of development plans or study designs that may have a significant impact on timelines or product labeling.

Synopsis / Protocol Development, Study Execution, & Study Interpretation

• Oversees all Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical scientists involved in these activities, and be accountable for the successful design and interpretation of clinical studies.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.

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, establishment of strategy for assigned compounds, and the direction of clinical scientists involved in developing documents required to outline the Company positions on research programs or regulatory applications (e.g. briefing reports), materials used for meeting presentations, and formal responses to communications received from the regulatory organizations or opinion leaders.
• 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 and conduct of due diligence evaluations assessing scientific, medical and development feasibility, evaluating complete or ongoing clinical trials, and regulatory interactions and future development plans.
• Contributes to the development and negotiation of clinical development plans for potential alliances and or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during DD visits and alliance negotiations and represents clinical science on internal assessment teams.
• For ongoing alliance projects, will interface with partner to achieve Takeda's strategic goals while striving to maintain good working relationship between Takeda and partner.

Leadership, Task Force Participation, Upper Management Accountability

• Interacts with research division and other function based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as scientific content matter expert for assigned compounds.
• Represents clinical science and contributes to or leads internal task forces and Therapeutic Area internal teams as well as global cross-functional teams as appropriate.
• Mentors, motivates, empowers, develops and retains staff to support assigned activities.

EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:

Education and experience

• MD,MD/PhD, or internationally recognized equivalent plus 3 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).
• Previous experience successfully leading matrix teams preferred.
• Previous experience in designing and executing first in human and early proof of concept trials 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 teams
• Diplomacy and positive influencing abilities

Knowledge

• Neurology Therapeutic area knowledge preferred
• Specialization in Neurology preferred
• Subspecialty expertise in neuromuscular disease or neurodegenerative disease preferred
• Regional/global Regulatory requirements
• GCP/ICH

TRAVEL REQUIREMENTS:

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

Requires approximately 10 - 20% travel.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy