Senior Clinical Scientist, Hematology, Neuroimmunology, and Specialty Care

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Job Description

Senior Clinical Scientist, Hematology, Neuroimmunology, and Specialty Care

Cambridge, MA

Hybrid

OBJECTIVES/PURPOSE

The PDT BU R&D group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases.  Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, neurologic, hematologic, and other complex diseases.

The Senior Clinical Scientist, Hematology, Neuroimmunology and Specialty Care (HNSC) will support the HNSC Team in all activities related to development of HNSC assets. This will include but not be limited to support of protocol concept development, protocol development, study start-up, study execution, data cleaning, preparation of the Clinical Study Reports, and support of regulatory filings.

The incumbent’s role will include contributing to the overall global (US/EU/Japan) clinical development strategy for multiple assets within the HNSC portfolio, taking into consideration the medical, scientific, regulatory and commercial issues. He/she will contribute to guiding a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has responsibility for integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned compounds in multiple regions. Applies clinical/medical decision making to clinical development issues. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.

ACCOUNTABILITIES

• Develop independently or in collaboration with different functions in Clinical R&D the clinical trial-related documents such as protocol concept sheet and protocol. Develop/coordinate amendments and updates as necessary.  Contribute to the development of IB, case report forms and ICF and clinical development plan.
• Support preparation of budgets related to each clinical project together with other functions in Clinical R&D.
• Develop clinical timelines together with other functions in Clinical R&D and maintain project status reports.
• Participate in preparation of clinical product forecasts to supply Clinical projects.
• Support, contribute and coordinate in preparation of final reports including data analysis, integrated clinical statistical final study report, clinical sections of regulatory submissions (i.e. IND and NDA).
• Prepare literature reviews as needed.
• Contribute personal expertise to resolution of unique and/or problematic clinical study issues.
• Present lectures and data at internal and external scientific meetings.
• Participate and give presentations at investigator meetings.
• Support other functions with scientific information regarding the use of immunoglobulin products.
• Train/coach new team members to write clinical documents such as clinical concept sheets and protocols.
• Present training session on TA-related topics and results of clinical studies to PDT

DIMENSIONS AND ASPECTS

Leadership

Global perspective with a demonstrated ability to work across functions, regions, and cultures

• Ability to identify potential challenges and opportunities and make recommendations
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
• Invests in helping others learn and succeed
• Able to influence without authority at senior (TET/TET-1) level
• Demonstrates agile leadership by seeking to understand with the ability to evolve idea as needed.

Decision-making and Autonomy

• Accountable for acting decisively and exercise sound judgment in making decisions with limited information
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
• Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
• Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
• Develops executable plans and meets budget and deadlines
• Builds a culture of data driven decisions 

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
• Strong communicator, able to persuasively convey ideas verbally and in writing
• Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders

Innovation

• Disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities
• Continuously challenging the status quo and bringing forward innovative solutions
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

• Delivers solutions to abstract problems across functional areas of the business. 
• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.

EDUCATION AND EXPERIENCE REQUIREMENTS

• Minimum of 5 year’s experience with clinical research drug development in a pharmaceutical, or biotech industry.
• Master’s degree required, advanced university degree preferred (MD, PharmD, DVM or PhD), preferably in medical or related scientific field.
• Knowledge of clinical research discipline and GCP.
• Excellent verbal and written communication skills.
• Presentation, organizational and interpersonal skills are a requirement.
• Confident decision-making, and ability to work affectively as a team leader, team member or individually.
• Interest in application of clinical/medical knowledge in drug development.

• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
• Ability to provide data that will resolve or simplifies complexity between commercial, operations, and strategy
• Resilient and comfortable working through large scale global change management

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and company match of charitable contributions
• Family Planning Support
• Flexible Ways of Working
• Tuition reimbursement

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

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

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

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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.

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