Senior Scientific Director Neurodegenerative Disorders

Job Description Are you looking for a patient-focused company that will inspire you and support your career?
If so, be empowered to take charge of your future at Takeda.
Join us as a Senior Scientific Director, Clinical Science, Neuroscience TAU 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.
OBJECTIVES:The Senior Scientific Director:
Leads, drives, or contributes to strategy for the development of assigned internal or partnered pipeline compound(s), for specific Takeda initiatives, or for business development opportunities while considering the clinical, scientific, regulatory, commercial, and organizational aspects and leads, or is a key member of, multi-disciplinary, multi-regional, matrix team(s) in highly complex decisions.Responsible for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a project plan that will result in the desired outcome.Applies scientific decision making to clinical development, licensing, and portfolio questions.Interacts with and influences R&D senior leadership decision-making by setting strategic direction.
Across these activities, they work closely with Global Clinical Leads or Disease Area Unit Heads.
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: Team leadership / membership
Represents Clinical Science on project, clinical, and diligence teams or ad hoc working groups.Supports Global Project and Clinical Teams to ensure that working group activities, e.g.
indication expansion, LCM, or BD activities, are aligned with the global strategy; may lead working groups and task forces within programs, initiatives, due diligences, etc.Contributes to the overall Asset Strategy by contributing to the Clinical Development Plan, 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 or program.Represents Clinical Science on pre-clinical research project teams to give input into the clinical development and translational strategy and ensures the overall goals are in line with disease area and therapeutic area strategies.Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan or disease area strategy 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 or supervisor to other medical directors or 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.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.Represents Clinical Sciences with external consortia including pre-competitive efforts to enhance disease area readiness for clinical trials.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.Leads the development and negotiation of clinical development plans for potential alliances or in-licensing opportunities, interacts with upper management of potential partner/acquisition companies during due diligence 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 functions 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 or disease areas.Represents clinical science and contributes to or leads internal task forces and Therapeutic Area internal teams, including disease area units as well as global cross-functional teams as appropriate.Hires, mentors, motivates, empowers, develops and retains staff to support assigned activities.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:EDUCATION Ph.D./PharmD or equiv.
experience; MD may substitute for Ph.D. with suitable experience.BEHAVIOURAL COMPETENCIES AND SKILLS: At least 15 years experience in a scientific discipline with expert knowledge of pharmacology or medicine and working knowledge of other disciplines such as toxicology, physiology, metabolism, biochemistry, chemistry, statistics and experimental design.
This includes an understanding of current scientific approaches, problem solving techniques and statistics used in experimental work.5 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned).Previous experience successfully leading matrix teams.This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
LocationsBoston, MA
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
Job Exempt Yes

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