Associate Director, Site Start Up and Maintenance

Takeda Pharmaceuticals; Charlotte Amalie (United States Virgin Islands); Remote; USD 153,000 - 242,000; Full time

Job summary

An innovative pharmaceutical company is seeking an Associate Director for Site Start Up and Maintenance. This role is pivotal in overseeing site management and ensuring the effective execution of clinical trials. You will lead a dedicated team, drive innovative processes, and collaborate with various stakeholders to enhance site performance. If you're passionate about improving patient outcomes and thrive in a dynamic environment, this opportunity offers a chance to make a significant impact in the industry. Join a values-led organization committed to transforming healthcare for a brighter future.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Volunteer Time Off

Sick Leave

Paid Vacation

Short-term Disability

Long-term Disability

Qualifications

• 8+ years in Clinical Operations with increasing responsibilities.
• Expertise in clinical trial regulations and ethics committee submissions.

Responsibilities

• Manage and mentor assigned staff in site startup and maintenance.
• Partner with CROs and Clinical Operations to improve metrics.

Skills

Clinical Operations

Project Management

Site Budgeting

Trial Optimization

Data Analysis

Leadership

Education

BS degree in Life Science

Advanced degree (preferred)

Tools

Clinical Trial Management Systems

Database Structures

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’sPrivacy 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 to inspire you and empower you to shine? Join us as the Associate Director, Site Start Up and Maintenance based remotely reporting to the Head, Site Start Up.

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 toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be a necessary contributor to our inspiring, bold mission.

GOALS:

• The Associate Director, Site Start Up and Maintenance is responsible for line management of assigned staff, as well as defining, developing, and delivery of the global site regulatory and site budgeting and contracting maintenance tasks, by partnering with internal and external study team members.
• Provide guidance to staff and oversee the analysis of clinical trial intelligence data and its application to effectively conduct accurate and effective resourcing forecasts, robust planning, and on time delivery of site maintenance tasks.
• Directly support priority or highly complex projects through study closure.
• Champion the creation and implementation of innovative processes, methodologies, data and technologies that will ensure ongoing delivery of valued site startup and site maintenance services.

ACCOUNTABILITIES:

• Responsible for line management, mentoring, and development of assigned staff
• Accountable for defining, developing, and delivery of site maintenance tasks
• Partners with CRO's, Clinical Operations teams, and TAU partners to improve overall metrics and implement processes
• Provides guidance, oversight, and training to the Site Start Up and Maintenance Teams, delivering activities in support of Clinical Programs, including data and methodologies for efficient and effective site maintenance planning, and modeling
• Ensures consistent standards are applied to the site maintenance process across project portfolios and supports continuous improvement activities while developing and implementing TA-aligned strategies / approaches
• Drives the creation and implementation of innovative solutions to improve processes and accelerate site maintenance timelines
• Leverages leading industry tools and data sources to provide data on timelines and performance to assist study teams with study site maintenance timeline forecasting
• Agrees to deliverables on a country and site-level basis with the study team and monitor adherence to these. Promptly recognize and remediate potential delays, and escalate non-performance as needed.
• Leads the cross-functional site maintenance team, utilizing the appropriate team members to support the study site maintenance requirements
• Serves as point of escalation and assists in resolution of issues
• Act as a role model for Takeda’s values

EDUCATION AND EXPERIENCE:

• BS degree or international equivalent in a life science required, advanced degree preferred.
• 8 or more years of experience in Clinical Operations, Project Management, study start-up, site budgeting and contracting and / or trial optimization with evidence of increasing responsibility within a pharmaceutical company, CRO or relevant industry vendor required.
• 5 or more years of direct responsibility in site management and oversight of the site maintenance processes of clinical research studies at a sponsor or CRO.
• Direct experience in the pharmaceutical industry or related field required.
• Expertise in clinical trial regulations and ethics committee submissions.
• Expertise in site contract and budget amendments administration.
• Expertise with leading edge trial optimization vendors, tools, and methods.
• Experience in line management and working in a matrix environment.
• Proficiency with software models and database structures.
• Expertise in principles driving site maintenance strategies including site contract amendments.
• Ability to strongly demonstrate, interpret, explain, represent, and drive unbiased data insights into clinical trials operational delivery.
• Ability to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate and lead within a global matrixed team.
• Ability to explain data, facilitate decision making processes to be data driven.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$153,600.00 - $241,340.00

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.

U.S. based employees may be eligible for short-term and/or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

YesIt 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.