Associate Scientific Director, Clinical Scientist

Company: Takeda Pharmaceutical
Location: Weymouth
Posted on: November 13, 2021

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's and . I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAre you looking for a patient-focused, innovation-driven company to inspire and empower you? At Takeda, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation and work toward excellence in everything we do. We foster an inclusive and collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.As the Associate Scientific Director, Clinical Scientist you will report to the VP, Clinical Science, Hematology in our Cambridge, MA office.RESPONSIBILITIES:

• Provide medical and scientific support for our clinical research and product development programs under the direction of Global Clinical Development Lead, including medical monitoring and medical support roles
• Be an essential member of the team managing the design and execution of clinical trials to support the advancement and registration of transformative therapies for rare genetic disease and rare hematology
• Help prepare clinical output summary reports, clinical data reviews of ongoing studies, PowerPoint presentations of the clinical data, clinical development plans, clinical trial concepts/synopses, clinical protocols, patient profiles, safety narrative and clinical study reports
• Provide clinical scientist input into IRB, EC, and regulatory questions
• Support the Global Clinical Development Lead and the Medical Monitor in the ongoing monitoring and review of clinical data
• Support GCDL, medical monitors and other clinical science personnel to provide scientific leadership in execution of clinical trials, including and not limited to site qualification visits, site initiation visits, site personnel training, data monitoring committee meetings, and endpoint adjudication committee meetings
• Be an essential resource to address site questions and clarify issues arising during conduct of clinical studies
• Help with the compilation, interpretation, writing, review, and reporting of clinical trial data
• Be a scientific resource to teams to facilitate quality processes and deliverables and assist with study execution and problem resolution (clinical operations, medical writing, data management, PV)
  • Work with Global Clinical Development Lead and the clinical sub team to ensure that all development and product support activities for the assigned projects are coordinated
  • Work with Clinical Development partners such as Clinical Operations, Biostats, Regulatory, Commercial, Compliance, and management teams
  • Support the GCDL when participating in clinical/medical advisory panels, steering committees and investigator meetings
  • Remain up-to-date with current information on pharmaceutical regulations, guidelines, and practices and therapeutic area knowledge and ensures best practice across all activities
  • Support the GCDL to provide expert scientific clinical development advice and leadership to the project teams to develop Phase I-IV clinical programs.
  • Help with the development of clinical synopses and protocols and clinical study reports for scientific and operational accuracy.
  • Participate in drug safety surveillance for Development projects.Education & Experience Requirements:
    • PhD and 10 plus years' of experience
    • Experience in clinical research and organizational management within the pharmaceutical industry, a CRO or similar organization
    • Experience designing and conducting Phase II-III clinical trialsTravel Requirements:
      • Availability to travel up to approximately 25% of time.Effective November 1, 2021, 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. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. 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. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they 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 ProgramsThis job posting excludes CO applicants.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.EEO StatementTakeda 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.LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Takeda Pharmaceutical, Weymouth , Associate Scientific Director, Clinical Scientist, Executive , Weymouth, Massachusetts