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Associate Scientific Director/Scientific Director Clinical Science - GI

Company: Takeda Pharmaceutical
Location: Dumont
Posted on: November 18, 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 that will inspire you and empower you to shine? Join us as an Associate Scientific Director/Scientific Director, Clinical Science 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:

  • The Associate Scientific Director/Scientific Director, Clinical Science represents and may lead clinical science on the regional (US) clinical development of assigned Takeda pipeline compounds.-
  • Leads a multi-disciplinary, matrix team ensuring that scientific issues are appropriately considered with respect to highly complex data findings.-
  • This individual has the responsibility for influencing the creation, maintenance, and execution of a clinical development plan that will result in the regulatory approval of the compound in multiple regions.POSITION ACCOUNTABILITIES:Trial Data Monitoring and Data Cleaning
    • Review clinical trial data in the database to ensure data consistency across multiple CRF pages and generate queries if necessary.
    • Manages collection of necessary information to assess issues relating to protocol conduct and/or individual subject safety. Provides preliminary assessments to Medical Monitor for review and approval.
    • Reviews and assesses overall safety information in conjunction with Pharmacovigilance and Medical Monitor of record.Clinical Development team participation and leadership
      • Represents Clinical Science on US/EU Development Teams and may serve as leader of this team. Supports the Global Development Team (US, EU, Japan) to ensure that the US/EU Development Team activities are aligned with the global strategy.
      • Responsible deliverables producing the Development Strategy, with significant contributions to assign sections of the Clinical Development Plan and Clinical Protocols.
      • Participates in recommending scope, complexity and size, and influence the budget of all aspects of a program.
      • Provides 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 for those areas assigned.
      • Contributes to high impact global decisions: monitoring and interpreting data from ongoing internal and external studies 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 labelingSynopsis / Protocol Development, Study Execution, & Study Interpretation
        • Assumes primary responsibility for the completion of protocol synopsis, obtaining scientific and corporate review committee approval including presentation and defense of the Synopses during review committee meetings, review and approval of documents related to study Protocols (e.g. Statistical Analysis Plans and Safety Management Plans) for assigned sections. Provides scientific contributions and overall content approval of written responses required by IRB / Ethics Committees and critical study training meetings (e.g. Investigator Meetings).Responsible for review of study data, interpretation of results and communication of study conclusions within the company for assigned sections.External Interactions
          • Successfully contributes to interactions with regulatory authorities / agencies and key opinion leaders relevant to assigned compound and participate in meetings with representatives of the regulatory organizations and the identification / contact/ maintenance of strong Company relationships with key opinion leaders. Influences establishment of strategy for the compound, and the development of 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 by the Company. Responsible for successful incorporation of advice / recommendations received from organizations or specialists into the design of clinical studies / programs as appropriate.Leadership, Task Force Participation, Upper Management Accountability
            • Interacts directly with research division based on pertinent clinical and development expertise to provide knowledge / understanding of market environment in line with status as Development scientific content matter expert for assigned compounds. May represent clinical science on internal task forces. May lead internal teams as appropriate.EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
              • Bachelor's degree and 9 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
              • Master's degree and 7 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
              • PharmD degree and 6 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)
              • PhD and 5 years of clinical research and/or clinical development experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of afore mentioned.)Skills:
                • 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 team
                • Diplomacy and positive influencing abilitiesKnowledge:
                  • Therapeutic area knowledge relevant to mechanism of action
                  • Regional/global Regulatory requirements
                  • GCP/ICH
                  • Emerging research in designated therapeutic areaLocation and Salary Information:
                    • This job posting excludes CO applicants.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 ProgramsEmpowering Our People to ShineAbsent 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.Discover more at takedajobs.comNo Phone Calls or Recruiters Please.#LI-JV2EEO 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, Tenafly , Associate Scientific Director/Scientific Director Clinical Science - GI, Executive , Dumont, New Jersey

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