Head, Oncology & Cell Therapy Clinical Operations

Company: Takeda Pharmaceutical
Location: Bronx
Posted on: May 13, 2022

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 Head, Oncology & Cell Therapy Clinical Operations in our Cambridge 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.OBJECTIVES/PURPOSE:

• You will reporting to the Head of the Global Development Office, responsible for leading the Oncology & Cell Therapy Clinical Operations group to partner with Therapeutic Area Units, Medical Affairs/Marketed Products, - Early Clinical Operations, to drive the clinical development operational strategy and design studies so that studies can be executed effectively and reach their objectives
• Accountable for the strategic input and oversight for all operational aspects of oncology and cell therapy clinical programs and studies, including trial planning, study / protocol design and development, execution within budget and timelines, quality and compliance
• Responsible for overall timely, high quality, and sustainable delivery of Takeda's clinical trial portfolio, as well as shaping the development strategy as member of GDO Leadership TeamACCOUNTABILITIES
  • Provides Leadership and direction to Oncology & Cell Therapy teams to ensure:
    • Reliable execution and delivery (quality, cost and time) of clinical studies to support global program requirements
    • Key partner to OTAU and other key groups within Takeda R&D and beyond to ensure strategic delivery of clinical studies.
    • Oversight of study operational strategies and plans, including regional input into global development plans
    • Cross-functional program and study teams oversight, including COPLs, COMs and CTAs
    • Oversight of overall study budget planning and management
    • Provides ongoing monitoring of operational issues/risks and remediation measures across portfolio
    • Collaborates with Heads of Clinical Site Startup & Engagement, Trial Insights and Performance Optimization Innovation & Data, Clinical Partner Management and Regional Clinical Operations Leadership to drive best in class operating model and to ensure success of global development programs.
    • Works with Clinical Partner Management group to provide strategic direction to partnership/s with external vendors, including functional and regional representation in partnership governance bodies and sponsor oversight for operational strategy, performance and quality
    • Ensures compliance with all applicable internal policies and procedures, GCPs, and all applicable regulations; ensure inspection readiness of all regulated activities
    • Drives Oncology & Cell Therapy Clinical Operations Senior Leadership Team to achieve functional objectives of globalization, standardization and efficiency
    • Directs staff to ensure attainment of established goals and objectives and compliance with policies and applicable regulations.
    • Responsible for long term talent development. Conducts targeted coaching and mentoring of clinical and medical staff.
    • Enables staff to perform their highest level by setting direction and providing feedback and information. Provides leadership, expertise, and guidance to management and other departments regarding clinical drug development, and specifically clinical programs.
    • Constantly strives to be ahead of the curve by focusing on Takeda's mission and strategic principles.DIMENSIONS AND ASPECTS:Technical/Functional (Line) Expertise
      • Thorough knowledge of pharmaceutical industry and deep understanding of drug development from research through commercialization
        • Experience in leading global, cross-functional teams
        • Sufficient knowledge of communication tools including online meeting and virtual meeting platforms to optimize communication and information exchange in a global environmentLeadership
          • Demonstrated ability to work across functions, regions and cultures
            • Enterprise level leadership with the ability to inspire, motivate and drive results
            • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
            • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
            • Ability to distill complex issues and ideas down to simple comprehensible terms
            • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organizationDecision-making and Autonomy
              • Broad decision making responsibilities:
                • Ability to make highly complex decisions that impact the enterprise
                • Accountable for decision making for designated function
                • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
                • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution -
                  • Accountable for designing and implementing vision and strategy for designated scopeInteraction
                    • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
                      • Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner
                      • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functionsInnovation
                        • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation
                          • Comfortable challenging the status quo and bringing forward innovative solutions
                          • Ability to take risks implementing innovative solutions, accelerating time to marketComplexity
                            • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
                              • Breadth of knowledge required across therapeutic areas, indications, and/or modalitiesEDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: -
                                • Bachelor's Degree or international equivalent required, Life Sciences preferred. - Advanced degree highly desirable.
                                  • 10+ years of applicable clinical development and operations experience, ideally with at least 5 years in a global leadership role -
                                  • 5+ years of line management experience including management of senior staff with accountability to therapeutic area development teams (highly matrix organization) and management of staff across multiple sites/regions
                                  • Experience in people leadership, managing global teams and coordinating collaboration with cross-functional teams
                                  • Strong strategic thinking, planning, execution, and communication skills
                                  • Expert knowledge of global regulatory and compliance requirements for clinical research, local country requirements and ICH GCP, including experience with global regulations and global regulatory inspections is required. - Familiarity with industry interpretations to ensure compliance while reducing complexity is desired.
                                  • Global/international experience required, including ability to collaborate with colleagues and staff in other locations.
                                  • Advanced knowledge of existing and emerging global GCP regulations (Americas, Europe, Asia and Japan) and industry interpretations to ensure compliance while reducing complexity
                                  • Senior management experience in Clinical Operations/clinical trial management, enabling technology solutions or related field, leading a medium to large organization and influencing senior-level management and key stakeholders
                                  • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
                                  • Operational experience in pharmaceutical drug development with significant direct exposure to clinical development
                                  • Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
                                  • Health care business acumen with a comprehensive understanding of the pharmaceutical industryAbsent 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.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 ProgramsDiscover more at -takedajobs.comNo Phone Calls or Recruiters Please.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.#LI-CS1EEO 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, New Rochelle , Head, Oncology & Cell Therapy Clinical Operations, Other , Bronx, New York