Associate Director, Clinical Scientist-Rare Diseases応募後で応募 求人ID R0034641 掲載日 06/15/2021 Location:Cambridge, Massachusetts
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Clinical Scientist 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 Individual contributor to our inspiring, bold mission. Responsible for providing scientific support for the company’s clinical research and product development initiatives under the direction of Global Clinical Development Lead
- Assist in the preparation of clinical output summary reports, Power Point presentations of the clinical data, clinical trial synopses, patient profiles
- Provides clinical scientist input into regulatory questions, runs ad hoc searches
- Preparation of targeted reviews/profile of outliers, search and summarize information relevant for various clinical documents preparation
- Assist the Clinical Development Lead in the review of trial data and development and review of clinical study documents, reports etc,
- Support GCDL to provide scientific leadership in execution of clinical trials
- Serve as a resource to address medical questions or clarify issues arising during conduct of the study
- Assist in the review, analysis and reporting of clinical trial data
- Assist with ongoing monitoring of safety data and regular medical review of clinical trial data.
- Serve as a scientific resource to cross-functional internal teams to facilitate quality processes and deliverables and assist with study execution and problem resolution (clinical operations, medical writing, data management, PV)
Other duties/ responsibilities:
- Collaborates with Global Development Team Lead to ensure that all development and product support activities for the assigned projects are coordinated and consistent;
- Interacts as needed with CD partners such as Clinical Operations, Regulatory, Commercial, Compliance, and Business Unit management teams.
- Supports the GCDL when participating in clinical/medical advisory panels, steering committees and investigator meetings.
- Assist the GCDL in assuring the conduction of appropriate steps to support Therapy Area Business Unit and Commercial Teams in crafting target product profiles.
- 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.
- Supports the GCDL to provide expert scientific clinical development advice and leadership to the project teams for the development of Phase I-IV clinical programs.
- Assists in the development of clinical studies and reviews clinical protocols and clinical study reports for scientific and operational accuracy.
- Participates in drug safety surveillance for Development projects.
- Act on behalf of GCDL leading the interpretation of trial data and development and review of clinical study documents, reports etc,
Education & Experience Requirements:
- Advanced degree (doctorate level) is required. Scientific/healthcare field preferred
- 3-5 yrs significant experience at independently designing, running and conducting Phase II & Phase III Clinical trials within the pharmaceutical Industry
- Experience in clinical trials & research and organizational management within the pharmaceutical industry, a CRO or similar organization.
- Industry Experience in designing and conducting Phase II-III clinical trials; and/or significant late-stage development research.
- Demonstrated ability to collaborate in a matrixed environment
- Experience in submissions of IND/CTX/NDA/MAA and interactions with Regulatory authorities, and /or
Other Job Requirements:
- Availability to travel approximately 25% of time.
- Availability to participate in early or late meetings/teleconferences.
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
CO applicants are excluded from this job posting.