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Associate Director, Clinical Research, Value & Evidence Generation, US Medical

Lexington, Massachusetts
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At Takeda, it's our people, our values and our culture that make us special. We share a sense of vocation and a desire to serve others that pulses through our entire organization. We're fortunate to be grounded in a history that gives us a long term perspective, the confidence to stick to what we believe in, and the humility to know we don't have all the answers.

We combine this outlook with an agility and tenacity to deliver for our patients that has fueled the growth of our business. But what really sets our company apart is something we call Patient Trust Reputation Business. It's the framework that enables us to translate our purpose and values into action. It's how we synchronize the diversity of our perspectives, strengths and expertise. And it’s what keeps our decision making tethered to what really matters.

Job ID R0150276 Date posted 05/02/2025 Location Lexington, Massachusetts

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Job Description

Associate Director, Clinical Research, Value & Evidence Generation, US Medical

Lexington, MA

Hybrid

OBJECTIVES/PURPOSE:

Provides clinical project management and leadership to ensure successful operational execution of all US Medical Clinical Research including, Medical Affairs Company Sponsored Studies (MACS) collaborative studies and Investigator Initiated Research (IIR). Specific objectives include:

  • Partners with Head of US Medical Clinical Science Lead to translate strategy into efficiently executable research plan; predicting and planning solutions to achieve successful operational execution to meet study objectives and strategic objectives; driving the team to achieve clarity on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies to get back on plan and navigating through the internal governance for projects.
  • Responsible for the design and conduct of MACS, collaborative studies and IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines.
  • Partners with US Medical TA leadership to determine project prioritization according to TA medical strategy. Proposes resource needs according to study complexity. Leads operational planning activities; reports on program progress; manage individual study budgets and communicates status to appropriate TA project manager; and execute communication and change management plans.
  • Represents and supports US Medical Clinical Research including synopsis and protocol development with all relevant stakeholders. Oversee reporting of study and/or program progress; ensure appropriate invoicing/budget management. Represents US Medical externally with external collaborators and investigators to develop and ensure execution of research plans, as applicable.  
  • Identifies and drives innovative process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management processes and systems.
  • Lead and matrix-manage high performing study teams, collaborating across the organization.

ACCOUNTABILITIES

Research Study Delivery

  • Defines annual IIR key objectives and KPI’s in partnership with Clinical Science Lead and TA Medical Teams,as applicable.
  • Provides ongoing reporting on individual studies program progress to inform budget management/invoicing, publications planning, and general progress on TA medical strategy(ies).
  • Ensures that regular reporting (e.g., key product dashboards, financial aspects) are delivered with high quality and partner with TA Project Managers as necessary.
  • Oversees & manages external CRO partners accountable to support operational execution of IIR work.

MACS and Externally Sponsored Research

  • Defines annual Research key objectives and KPI’s in partnership with Clinical Science Lead and TA Medical Teams.
  • Drive and deliver all aspects of clinical trial execution from study concept to final reporting

Research and Strategic Implementation Excellence

  • Identifies scalable and consistent reporting methods to transparently inform on key TA or medical products.
  • Provides direction and obtains buy-in from relevant internal stakeholders and team members to therapeutic, functional, or operational strategy.
  • Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
  • Continuously and efficiently manages stakeholders at various levels, across all US Medical functions.
  • Addresses and resolves project challenges, keeping leadership informed of critical considerations (e.g., resources, performance concerns). Provides clarity and direction in urgent or unexpected situations.
  • Provides clear and targeted messaging to teams, translating corporate priorities into clear and meaningful team goals
  • Identifies ways to accelerate the project execution where possible while maintaining high quality standards.
  • Manage the planning, operational and reporting logistics of the Research and/or other teams (including but not limited to: meeting schedule management, meeting facilitation, development of meeting materials with contributors, capture and follow up of action items and deliverables, distribution of minutes, and maintenance of relevant SharePoint site (or equivalent).
  • Partners with the Head of US Medical Clinical Research to lead and manage Research Team meeting, or other teams, through the project plan execution and holds to the highest standards for operational excellence and compliance in all US Medical activities.
  • Drive and deliver all aspects of clinical study execution from study concept to final reporting, coordinate and ensure team deliverables for project completion for assigned research activities across all functions.
  • Responsible for building quality relationships with key cross functional stakeholders, that result in valued and trusted partnerships and program support.
  • Proactively identifies potential issues or obstacles and achieves resolution or plans contingencies and follows issues through to resolution.
  • Provides financial oversight for program/study budgets.  Includes consolidation, vetting and prioritization of spending risks and opportunities, in partnership with Head of US Medical Clinical Research, and in collaboration with US MA Medical and Scientific Leads.
  • Leads the project risk management process and generates the cross-functional project risk register for assigned projects. Ensure that the risks identified for US Medical activities are reported up through to the Program Manager and Medical and Scientific.
  • Independently resolves complex issues and competing priorities that may impact achievement of goals, and creates mitigation plans and drives to resolution.
  • Works closely with the US Medical Strategy Team/Medical Unit and/or other cross functional teams, to balance operational execution with Research strategy.
  • Manages project status reporting and dashboards for a given program, including scheduled as well as ad-hoc updates.
  • Participates in regular project portfolio reviews at the Medical Franchise Unit for a given TA to ensure accurate information, timelines and budgets are completed to support project recommendations to Senior Management.
  • Generates collaboration, cooperation and communication across functions ensuring that team goals are achieved.
  • Provides direction, mentors junior colleagues, as applicable, looks for opportunities for junior staff to demonstrate their abilities; uses effective coaching techniques; leads by example. May have responsibility for line management of Senior Managers, as well as contractors or CRO service providers.
  • Orchestrates the involvement of appropriate cross-regional or cross-functional stakeholders in relevant communications, decisions and working group.
  • Establish best practices and embrace an open, learning, sharing culture.
  • Implement novel trial designs, including digital interventions, as applicable.

DIMENSIONS AND ASPECTS

Technical/Functional Expertise

  • Comprehensive understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory process, including clinical research, study design, and good clinical practice.
  • Strong clinical research and program management experienced in leading cross-functional clinical programs within Medical Affairs, Clinical Research, Regulatory, CMC or other drug development related function. Clinical Science experience a plus.
  • Experience managing study budgets across multiple Therapeutic Areas
  • Applied knowledge of performance management (e.g., metrics, dashboards)

Decision-making and Autonomy

  • Ability to predict issues, anticipate risks and solve problems
  • Ability to articulate & establish processes to foster cross-functional efficiency or resource scalability

Interaction

  • Flexibility, tolerance and diplomacy to best manage change and differing opinions
  • Ability to work in a highly complex, multi-cultural, often stressful environment
  • Highly effective communications skills – written and verbal
  • Demonstrated ability to concisely communicate/prepare presentations for management
  • Excellent organizational skills
  • Effective negotiation and positive influencing abilities
  • Proven ability to work effectively and diplomatically in conflict situations

Innovation

  • Experience in identifying and driving opportunities for process improvements with significant organizational impact and takes on, as needed, non-project responsibilities, which can include project management to implement new processes and systems

Complexity

Management of multiple tasks of varied complexity to enable successful delivery of multiple and/or complex projects within a single or across therapeutic areas for US Medical

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

Education

  • Bachelor’s Degree science, advanced science degree preferred
  • Project Management Professional certification with PMI desired

Knowledge & Experience

  • Minimum of 5 years of detailed & in-depth pharmaceutical industry, academic or hospital system experience and/or drug development experience in all phases of development with significant experience within related functions (e.g., Medical Affairs, Clinical Operations, Regulatory, CMC, Marketing).
  • Minimum of 5 years’ experience as a clinical project/program manager leading complex pharmaceutical, academic or hospital system clinical research deliverables in a multi-disciplinary, global or regional environment. 
  • Experience in leading global or regional cross-functional teams spanning drug development life cycle with emphasis on late-phase (i.e., Ph 3-4) and post-marketing development (e.g., thru Patent Exclusivity expiration).
  • Thorough understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of types of research trials in the pharmaceutical industry.
  • Knowledge of pertinent external guidelines related to research and publications, and current standards of practice.
  • Minimum of 3 years of matrix or indirect people management experience

Leadership Skills & Behaviors

  • Matrix project leadership and proven line management skills are required.
  • Proven strategic problem-solving ability and identify appropriate solutions.
  • Solid influencing skills and ability to negotiate in a matrix environment to optimize development and address barriers.
  • Highly effective written and verbal communication skills, including strong presentation skills.
  • Ability to lead business process transformation and implement organizational culture change.
  • Simultaneous management of multiple tasks of varied complexity.
  • Flexibility, tolerance and diplomacy to best manage change and differing opinions.
  • Excellent organizational skills.
  • Proven skills in negotiation, influencing without authority, managing through ambiguity, and working diplomatically through conflict.
  • Sufficient knowledge of all MS Office tools to effectively capture and communicate project information
  • Fluent in English.

ADDITIONAL INFORMATION

  • Must be able to work at computer for several hours at a time.
  • May travel ~10% of time, primarily within US with occasional international travel.

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 Programs

Empowering Our People to Shine Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

This job posting exclude Colorado applicants.

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:

Lexington, 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.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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.
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There are endless opportunities for people in science-related fields at Takeda. This is a company that focuses on the patients and their employees.

Tamara D. - Director, US Field Medical, GI

Patient centricity and the fact that we make decisions based on how they will impact the patient, trust, reputation and business – in that order – is what keeps me here. That is always steady.

Jill E. - Medical Affairs

It's comforting to know I have flexibility when it comes to managing my schedule and my family, especially through COVID. This flexibility gave me the time and capacity I needed to care of all of my responsibilities.

Tony P. - Managed Markets

I am overwhelmingly thrilled with Takeda's leadership, the care through COVID, and the decision making framework that prioritizes the patient, trust, reputation and business – in that order. It's all about building trust and honoring our commitments.

Dayna F. - Director, IG Community Support

The people here are fantastic. Everyone has been wonderful. The opportunities at Takeda are enormous. I don’t know why you would go anywhere else, incredible support system, everything a professional could ask for.

David M. - Sales

I love the fact that I am empowered to do what is right and what I need to do. If you are a person who likes to make decisions and be accountable and responsibile for your actions, this is the right company for you. If you want a company that cares for its employees, Takeda is a great fit for you.

Kristen H. - US Medical

Takeda walks the talk. When we say we value patients, trust, reputation and business – in that order – we mean it. The openness of Leadership, from Christophe to Ramona and others…it trickles down.

Barbara O. - Finance

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Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

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Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

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  • Honesty

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Lexington, Massachusetts


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