Associate Director, Strategic Outsourcing

Initial Therapeutics, Inc.; Boston (MA); On-site; USD 153,000 - 242,000; Full time

Job summary

An established industry player is seeking a strategic leader to oversee preclinical Contract Research Organizations (CROs) in the Boston area. This pivotal role involves enhancing operational efficiencies and expanding research capabilities to support drug discovery initiatives. The ideal candidate will possess a deep understanding of CRO management, strong project management skills, and the ability to foster collaborative environments. Join a forward-thinking team dedicated to innovation and excellence in research, where your expertise will directly impact the future of therapeutic advancements.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Tuition Reimbursement

Paid Volunteer Time Off

Sick Leave

Paid Vacation

Short-term Disability Coverage

Long-term Disability Coverage

Qualifications

• 10+ years in Pharma/Biotech with CRO management experience.
• Solid knowledge of FDA GLP and nonclinical study guidelines.
• Strong relationship management and negotiation skills.

Responsibilities

• Lead CRO management to support drug discovery programs.
• Cultivate strategic partnerships with key CROs.
• Evaluate CRO performance on operational metrics.

Skills

CRO Management

Strategic Planning

Negotiation Skills

Project Management

Analytical Skills

Education

Advanced Degree in Life Sciences

Business Administration

Tools

Smartsheets

Microsoft Software Tools

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 Noticeand 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

Objective / Purpose:

The Research Strategy and Operations function is responsible for integrating scientific acumen with business analytics and processes to deliver clear business plans, operational excellence and portfolio progression for the Takeda Research pipeline.

The AD/Director of Strategic Outsourcing will provide strategic oversight and relationship management of preclinical Contract Research Organizations (CROs) to enhance operational efficiencies and expand research capabilities, thereby supporting drug discovery programs. This role is crucial in shaping the strategic planning, vendor sourcing, evaluation, contracting, and monitoring of both business and scientific performance of key strategic CRO partners.

Accountabilities:

• Provide leadership, management and oversite for Strategic Outsourcing and Contract Research Organization (CRO) management to support Takeda Research projects, ensuring alignment with organizational goals, and regulatory and animal welfare requirements.
• Cultivate strategic partnerships with key CROs partners that are aligned with long-term Research objectives and innovation goals.
• Focus on building relationships that go beyond transactional interactions to create collaborative environments that foster mutual growth and learning.
• Conduct CRO site qualification visits and select CROs based not only on operational capabilities but also on their strategic alignment with the company’s vision, their ability to innovate, and their reputation in the industry.
• Consider the strategic geographical locations, therapeutic area expertise, and technological advancements of CROs in the selection process.
• Integrate CROs into the strategic planning processes, ensuring that their capabilities are fully leveraged in the company’s drug discovery efforts.
• Establish and maintain high-level executive connections between the company and the CRO to ensure open lines of communication and to strengthen the strategic relationship.
• Regularly engage in strategic discussions to align on expectations, share insights, and update on shifts in the industry landscape or company direction.
• Evaluate CRO performance on operational metrics like timeliness and budget adherence as well as fit to evolving Research and disease area strategies.
• Proactively identify strategic risks associated with outsourcing to CROs, including intellectual property issues, dependency risks, and alignment with long-term goals.
• Defines the strategy for implementing instrumentation (i.e. dashboard tools, databases) for strategic analysis, accessibility, and information sharing.
• Defines data management practices to ensure accountability to individuals that generate data.
• Participates in the strategic design and global guidance for any data initiatives by providing best practices, data guidance, key performance indicators, and metrics to support greater efficiency, consistency, and validation of business processes and decision-making.
• Provides recommendations on hardware and software procurement to support business goals on CRO management activities.
• Works with CROs to understand their development plans and how these align with the company’s future needs.

Education & Competencies (Technical and Behavioral):

• Advanced degree in Life Sciences, Business Administration, or related field preferred but may not be required based on industrial experience in a Pharma/Biotech R&D setting.
• Minimum of 10 years of experience in pharmaceutical or biotechnology industry with significant exposure to preclinical CRO management.
• Solid knowledge in all aspects of preclinical CRO management and oversight and has a solid foundation on the operational support needed to advance early and late-stage Research projects.
• Strong background in developing and managing analytics and tools used in managing CROs (i.e. Smartsheets, and other MS software tools)
• Solid understanding of FDA Good Laboratory Practices (GLP) for nonclinical studies as set forth in 21 CFR Part 58, as well as OECD and ICH Guidelines.
• Excellent negotiation and relationship management skills with proven track record of strategic planning and execution in a research environment.
• Deep understanding of drug discovery processes and Takeda therapeutic areas
• Strategic mindset and the ability to think critically and creatively to drive innovation and business growth.
• Strong project management skills, with the ability to prioritize and manage multiple initiatives simultaneously.

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:

$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.

LocationsBoston, MAWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull 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.