Senior Director, Clinical Data Management (Oncology & Cell Therapy)

Job Description

Are you looking for a patient-focused company to inspire you and support your career? If so, be empowered to take charge of your future at Takeda.

Join us as the Senior Director, Clinical Data Management (Oncology & Cell Therapy) reporting to the Head of Clinical Data Management based 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 work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers and work towards 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.

GOALS :

• Effective leadership, strategic planning, and oversight for one or several Therapeutic Area Units (TAUs) and / or operational units within Clinical Data Management (CDM).
• Set the vision, direction, and strategy for area(s) of responsibility and actively contribute to and align with the overall CDM, Global Integrated Clinical Trial Data Services, and Global Development Organization (GDO) strategies and operating models.

Lead operationalization activities to ensure on time, high quality and within budget delivery that enable successful trial data analyses for Takeda to deliver medicines to patients faster.

• Champion CDM operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CDM capabilities.
• An accomplished people and relationship manager, who will establish and maintain productive partnerships within CDM, functional leaders across R&D, and third-party service providers.

ACCOUNTABILITIES :

Accountable for the timely and high-quality delivery of clinical databases for assigned TAUs, ensuring fitness of purpose and compliance to applicable regulations and SOPs.

Proactively drive quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards.

• Lead the development of robust strategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making.
• Contribute to the overall strategic direction of Takeda R&D and the role of clinical data management in maintaining the company’s competitive advantage and delivering on Takeda’s business objectives.
• Support the Head of Clinical Data Management in leading cross-functional efforts to build out processes and infrastructure necessary to internalize key CDM capabilities and optimize overall operational delivery.

Represent CDM on key cross-functional initiatives.

• Drive significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models.
• Champion harmonization efforts across regions, TAUs and service providers.
• Recruit, select, develop, manage, motivate, coach and appraise the performance of direct reports. Build team commitment to goals, and create a positive and productive culture within the team.

Ensure appropriate training and be a leader and mentor for all DM globally.

Lead the development of SOPs, procedural documentation and continuous process improvement activities in collaboration with DM leadership team.

Identify areas for simplification and innovation as well as new and emerging enabling technologies.

• Represent CDM in global regulatory audits and inspections and ensure successful outcomes in line with business expectations.
• Establish, foster and enhance relationships within and across the global organization as well as with service providers.
• Be a deputy for the Head, Clinical Data Management as needed.
• Other responsibilities as assigned.

EDUCATION & EXPERIENCE :

• Bachelor’s / MS Degree or international equivalent preferred, or equivalent combination of education, training and experience.
• 15+ years of experience with degree, or equivalency of 20+ years experience in lieu of degree.
• 7+ years of line management experience with prior second-level management experience required.
• Successful experience managing operational vendor relationships and alliance partnerships at a program or portfolio level.
• Proven track record of strong project management skills and experience managing data management activities for large drug development programs.
• Requires advanced experience working on Phase I-IV studies across multiple therapeutic areas and programs, and be capable of leading DM activities to support regulatory submissions and inspections.
• Excellent verbal / written communication skills and ability to influence at all levels across functions and build effective relationships.
• Seasoned leader with a passion for people development and an ability to perform in a highly dynamic environment.
• Exceptional interpersonal skills, outstanding negotiation and problem-solving skills.
• Focused and versatile leader who excels under pressure, ambiguity, frequent change, or unpredictability.
• Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenges the status quo.

Locations : Boston, MA

Worker Type : Employee

Worker Sub-Type : Regular

Time Type : Full time

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