Scientific Director, Clinical Science- Neuroscience:
Takeda Pharmaceutical

1568411422
Takeda Pharmaceutical
Littleton Colorado
Pharmaceutical
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Description
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Job Description
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Scientific Director in our Neuroscience Therapeutic Area Unit in our Cambridge, MA or Zurich, Switzerland 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:
Leads, drives, or contributes to 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; Joins multi-disciplinary, multi-regional, matrix teams as they address, and take decision in, highly complex circumstances. 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 decision making to clinical development issues; 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; Supports the Clinical Subteam to ensure that the clinical team activities are aligned with the global strategy; 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 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. Ensures that at all times the scientific rigor and integrity of clinical trials is maintained and that the resulting data are of high quality to allow data-driven decision-making. In this role works with, and leads, other functional representatives to ensure optimal data quality.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
Oversees Clinical Science activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies. Serves as an advisor to other clinical science personnel involved in these activities, and contributes to the successful design and interpretation of clinical studies. Interprets data from an overall scientific standpoint as well as within the context of the clinical significance to individual patients. May present study conclusions to Management and determines how individual study results impact the overall compound strategy.
Data Monitoring
Responsible for clinical data monitoring activities, assessing issues related to protocol conduct and data quality and integrity. Assesses overall safety information for studies and compound in conjunction with the study medical director and Pharmacovigilance. May oversee other clinical scientists with respect to assessment of these issues. Informs final decisions regarding study conduct related to scientific integrity.
External Interactions
Contributes and leads interactions with key opinion leaders relevant to assigned compounds and therapeutic area. Contributes to 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 or contributes to incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.
Due Diligence, Business Development and Alliance Projects
Consulted for evaluation of potential business development opportunities and conduct of due diligence evaluations assessing scientific 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 and represents clinical science on internal assessment teams. For ongoing alliance projects, may 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
MSc/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. 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 desired Regional/global Regulatory requirements GCP/ICH
In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

WHAT TAKEDA CAN OFFER YOU:
• 401(k) with company match and Annual Retirement Contribution Plan
• Tuition reimbursement Company match of charitable contributions
• Health & Wellness programs including onsite flu shots and health screenings
• Generous time off for vacation and the option to purchase additional vacation days
• Community Outreach Programs

Empowering Our People to Shine

Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

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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.

Locations
Cambridge, MA

Zurich, Switzerland
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time