Senior Director, Clinical Operations - Oncology

Company: Takeda Pharmaceutical
Location: Boston
Posted on: January 27, 2023

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 Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?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.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.OBJECTIVES:

• Responsible for Oncology clinical operations strategy, execution, and management of clinical programs in assigned therapeutic area or disease Pathway or therapeutic area(s) or disease pathway(s), supporting clinical strategy defined in the Clinical Development Plan (CDP).
• Responsible for Oncology clinical operations financial planning/forecasting and budget management for assigned therapeutic area or therapeutic areas. Responsible for administrative budget oversight for direct and indirect reports.
• Represents Oncology clinical operations as primary point of contact for therapeutic area, internal stakeholders and Strategic Partners and vendors.
• Responsible for leading the development of consistent Clinical Operations processes and creating the support for unified approaches across therapeutic areas.
• Initiates, develops, leads and/or participates in global initiatives representing clinical operations in support of Takeda R&D objectives.ACCOUNTABILITIES:
  • Collaborates with Oncology global functional heads and TA leadership to define operational strategy for clinical programs, including risk management and contingency planning for clinical programs and clinical studies. Responsible for on-time, on-budget delivery of oncology clinical trials.
  • Ensures Oncology clinical operations process and work product is compliant with global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
  • Direct management of clinical operations staff.
  • Responsible for oversight of clinical budget planning/forecasting and management for assigned therapeutic area.
  • Oversees, reviews and approves operational due diligence for new compounds/alliances for budgeting, timelines, and enrollment modelling.
  • Maintains oncology therapeutic area knowledge and continually assesses impact of new and evolving information on operational strategies.
  • Escalates issues related to quality, timelines and budget and provides recommendations to upper management for resolution of these issues.
  • Supports strategic outsourcing by participating in strategic vendor governance, including identification and resolution of performance issues.
  • Leads and/or participates in initiatives for process, technology or other continuous improvement to achieve cost-reduction, time-savings, efficiency, quality and/or other business objectives.
  • Responsible for functional leadership in oncology clinical operations, including both direct line management (hiring, training, staff assignments, coaching, mentoring, and performance management) and indirect management of global clinical operations staff in a Matrix environment.
  • Acts as a role model for Takedas values.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
    • Bachelor's Degree or international equivalent required, Life Sciences preferred. Advanced degree highly desirable.
    • 15+ years' experience in pharmaceutical industry and/or clinical research organization, including 10+ years clinical study/program management, including at least 6 years of line management experience. 5+ Years' experience in Early Oncology and a proven track record of leadership and project management success at the director level required.
    • Expert knowledge of global regulatory and compliance requirements for clinical research, including but not limited to US CFR, EU CTD, local country requirements and ICH GCP.
    • Global/International experience required, including ability to manage intercultural regionally based teams and fluent business English skills (oral and written).
    • Experience in successful change management (strategy, initiation, development and implementation of important, organization wide changes).
    • Previous line management or direct management of team members.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 ProgramsBase Salary Range: 194,000.00n to 278,000.00. Employees may also be eligible for Short Term and Long-Term Incentive benefits. 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. The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.Empowering Our People to ShineDiscover more at No Phone Calls or Recruiters Please.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. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

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