Senior Director, Clinical Data Management

USA - 3316 Takeda Development Center Americas, Inc.; Cambridge (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda in Boston, MA seeks an experienced Head of Clinical Data Management to lead one or more TAUs. You will define vision, drive strategy, and ensure on-time, high-quality data delivery across trials, while aligning with I&D and GDO objectives.

This role demands senior leadership, deep DM expertise across Phase I–IV, strong vendor management, and proven ability to influence across functions and regulators.

Qualifications

• Bachelor’s/MS Degree or international equivalent preferred; 15+ years experience or 20+ years in lieu of degree accepted
• Minimum 7+ years of line management experience
• Experience managing operational vendor relationships and alliance partnerships
• Experience across Phase I-IV studies and regulatory submissions

Responsibilities

• Deliver timely, high-quality clinical databases for assigned TAUs within budget and regulatory standards.
• Lead DM resourcing, outsourcing, technologies and risk management strategies to enable efficient delivery.
• Represent CDM in cross-functional initiatives and regulatory audits/inspections.
• Coach and develop DM teams to maintain world-class performance.

Skills

Strategic leadership

People management

Project management

Vendor management

Regulatory submissions

Cross-functional collaboration

Education

Bachelor’s/MS Degree or international equivalent preferred

15+ years experience or 20+ years in lieu of degree

7+ years of line management experience

Experience managing vendor relationships and alliances

Job description

OBJECTIVES/PURPOSE

Responsible for the effective leadership, strategic planning, and oversight for one or several Therapeutic Area Units (TAUs) and/or operational units within Clinical Data Management (CDM). Sets the vision, direction, and strategy for area(s) of responsibility and actively contributes to and aligns with the overall CDM, Innovation & Data (I&D) and Global Development Office (GDO) strategies and operating models. Leads 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. Champions CDM operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CDM capabilities. Is an accomplished people and relationship manager, establishing and maintaining 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 drives quality, efficiency, and innovation to ensure data management deliverables are met within the established timelines, budget, and applicable standards. Leads the development of robust strategies for DM resourcing, outsourcing, technologies and risk management to enable more efficient management, collaboration, and pro-active decision making. Contributes 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. Supports 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. Represents CDM on key cross-functional initiatives. Drives significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models. Champions harmonization efforts across regions, TAUs and service providers. Recruits, selects, develops, manages, motivates, coaches and appraises the performance of direct reports. Builds team commitment to goals, and creates a positive and productive culture within the team. Ensures appropriate training and acts as a leader and mentor for all DM globally. Leads the development of SOPs, procedural documentation and continuous process improvement activities in collaboration with DM leadership team. Identifies 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. Establishes, fosters and enhances relationships within and across the global organization as well as with service providers. Act as deputy for the Head, Clinical Data Management as needed. Other responsibilities as assigned.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

Bachelor’s/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience Degree with a minimum of 15 plus years of experience or equivalency of 20 plus 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 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; challenge the status quo.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. For Location: Boston, MA U.S. Base Salary Range: $212,000.00 - $333,190.00 The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

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

Locations Boston, MA

WORKER TYPE

Worker Type Employee

WORKER SUB-TYPE

Worker Sub-Type Regular Time Type Full time

JOB EXEMPT

Job Exempt Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own. Takeda is an equal opportunity employer.