Senior Clinical Scientist, Clinical Science Rare Genetic and Hematology (RGH) Therapeutic Area

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Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Clinical Scientist, Clinical Science RGH, 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:

Responsible for providing scientific support for the company's clinical research and product development initiatives under the direction of Clinical Development Lead (CDL).

POSITION ACCOUNTABILITIES:

• Assist in the data review of patient profiles and develop site queries as needed.
• Assist the Medical Monitor (CDL) in the review of trial data and development and review of clinical study documents, reports etc,
• Address medical questions or clarify issues arising during conduct of the study.
• Summarize information relevant for various clinical documents preparation
• Support CDL in execution of clinical trials.
• Provide relevant scientific expertise to internal teams, including clinical operations, medical writing, data management, pharmacovigilance to ensure quality processes and deliverables.
• Serve as a resource to address medical/ scientific questions or clarify issues arising during conduct of the study.
• Assist with ongoing monitoring of safety data and participates in drug safety surveillance for Takeda’s products in development.
• Collaborates with CDL, and Global Product Team Lead to ensure that all development and product support activities for the assigned projects are coordinated and consistent.
• Interacts as needed with Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
• Supports the CDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.
• Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
• Provides input into regulatory questions, runs ad hoc searches
• Remains up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
  

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• PharmD/ PhD/ Pharm D PhD is preferred
• Minimum 9 years in clinical research within the pharmaceutical industry, Clinical Research Organization (CRO) or similar organization.
• Experienced in designing and conducting clinical trials, and/or significant late-stage development research.
• Experienced in submissions of Investigational New Drug (IND), /Clinical Trial Agreement (CTA)/ New Drug Application (NDA)/MAA and interactions with Regulatory authorities and Ethics Committees.
• Experience in hematology and or rare diseases is a plus.
• Able to work independently, prioritize and meet project timelines
• Demonstrated ability to collaborate in a matrixed environment, able to build and support teams of diverse backgrounds.
• Able to effectively present information. Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes.
• Possess good analytical skills and ability to review emerging data and clinical outputs to make appropriate decisions and ensure quality results and safety. It is expected that incumbent will take initiative and work independently, however, ongoing communication with CDL is a vital part of problem-solving and decision-making.
  

Location and Salary Information:

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy

Base Salary Range: $130,200.00 to $186,000.00, based on candidate professional experience level. Employees may also be eligible for Short-Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

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

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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.