Director, US Medical Clinical Research - Medical Engagement & Innovation

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Job Description

About the role:

Join Takeda as a Director, US Medical Clinical Research - Medical Engagement & Innovation where you will drive clinical, collaborative and above-therapeutic area external engagement research activities to advance differentiated value-based care. Strategic thought partner with Head of USM Clinical Research and USM External Affairs to create a virtuous cycle of collaborative and patient-centered research, engagement and partnerships to transform care. As part of the US Medical Affairs team, you will report to the Sr. Director & Head, US Medical Clinical Science, Clinical Research & Research Process Excellence. This is a hybrid position based in Exton, PA.

How you will contribute:

OBJECTIVES/PURPOSE

• Strategic Influencer, leads and implements innovative research initiatives and engagement activities designed to advance effective patient-centered healthcare solutions in prioritized areas of interest to Takeda.

• Strategic thought partner to align with external needs to identify and shape partnerships & solutions that link the demands of the current healthcare ecosystem to Takeda priorities. Accountable to successfully deliver and oversee USM clinical and collaborative research (e.g.,MACS, Complex and/or Interventional Collaboration studies) programs in accordance with internal and external legal, compliance and regulatory guidelines and in alignment with USM strategy and TA medical strategies.

• Influence and leads matrix-managed high performing study teams, collaborating with Clinical Research Operational Lead/Clinical Science and Therapeutic Area Medical Units to implement best practices to successfully execute clinical and collaborative research program deliverables in accordance with integrated TA medical plans and strategies.

• Provide strategic input and leads US Medical Clinical Research including synopsis and protocol development with all relevant stakeholders. Represents US Medical externally with external collaborators and investigators to develop and ensure execution of research plans, as applicable. 

• May lead special projects according to USM business needs (e.g. process optimizations).

ACCOUNTABILITIES

Strategy, Execution and Matrix Management

• Drives USM Clinical Research. Medical Engagement & Innovation studies. This includes:

• Providing clear direction on study strategic vision and remit for study team, coaches Associate Directors and Clinical Sr/Research Managers.

• Assurance of quality work product including comprehensive collaborative research, publication and support with external engagement plans.

Fosters Transparent Communication Builds Relationship Among Key Stakeholders

• Understands the US Medical and US BU stakeholder map and proactively influences and supports meaningful and constructive relationships to further effective partnerships. 

• Supports cross-functional efforts with the broader Takeda functions, USM Medical Teams to achieve team strategic imperatives and key objectives.

External Medical Research Leadership

• Strategic thought partner with US Medical External Affairs, US Medical TA leadership (Heads, Medical Directors, Scientific Directors) and other USM Functional Leaders (e.g. HEOR) to understand unmet clinical or innovation needs.

• Develop and deliver comprehensive collaborative research plans that address identified unmet clinical or innovation needs in alignment with TA or Medical Unit strategy; these plans will clearly articulate activities and clinical studies that link to a strategic publication plan or other efforts to deliver transformative patient care.

• Partner with US Medical External Affairs to influence and create comprehensive engagement and research plans with prioritized external organizations. Sets the strategic direction for the collaborative research and is the key contact with the collaborating organization to cultivate medical relationships and develop research plan.  

• Delivers collaborative research and cross functional medical and external efforts to identify, develop, and implement health care quality metrics and care pathways in alignment with USM TAs.

• Partner with TA Medical Heads and other USM leaders to create comprehensive external communication plans to communicate important research activities, collaborations and novel approaches to patient care. Represents Takeda as required to deliver associated communication plans and as a subject matter expert.

Clinical Research and Operational Excellence

• Influences and demonstrates our commitment to transform patient centered care through collaboration and the advancement of digital technology & innovation

• Maintains and grows trust & reputation as a partner of choice through clinical, collaborative and external research

• Strategic thought partner in advancing scalable healthcare solutions for systems of care, providers and demonstrates patient value through evidence generation

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Comprehensive understanding of the pharmaceutical industry and regulations governing medical functions within industry activities and medical regulatory processes.

• Strong understanding of scientific concepts, patient care value creation and digital innovation.

• Significant experience in clinical study management and project management.

Decision-making and Autonomy 

• Broad decision-making responsibilities:

• Ability to seek diverse input from multiple stakeholders to drive innovative solutions

• Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution 

• Accountable for designing and implementing vision for USM Clinical Collaborative Research & Innovation that complements USM vision and TA strategies.

Interaction

• Ability to work in a global and highly matrixed ecosystem with a high degree of complexity.

• Foster solutions-oriented thinking by fostering a culture of performance, accountability, simplicity, empowerment, external orientation and curiosity.

• Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace.

• Effectively negotiates and collaborates with business partners and demonstrates the ability to resolve conflict in a constructive manner.

• Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to Global Medical Affairs, commercial business units, regulatory, medical communications, and market access.

Innovation

• Thought partner, influencer and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.

• Comfortable challenging the status quo and bringing forward innovative solutions.

• Ability to develop and implement business solutions based on trends, needs, opportunities and market direction within pharmaceutical industry.

• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

What you bring to Takeda: 

Education

• Pharm D, PhD, M.P.H., M.S., Bachelor's or equivalent education. Area of Specialization: Clinical Science, Re-search and Development, Health Outcomes, Epidemiology, Health Policy, Health Services Re-search, Pharmacy, Public Health, Health Administration

Knowledge & Experience

• Minimum of 12 years of detailed & in-depth pharmaceutical industry experience and drug development in all phases of development with significant experience within related functions (e.g., Medical Affairs, Clinical Operations, Regulatory, CMC, Marketing).

• Minimum of 10 years’ experience as a project/program manager leading complex pharmaceutical project deliverables in a multi-disciplinary, global environment. 

• Experience in leading cross-functional teams with emphasis on late-phase (i.e., Ph 3-4) and post-marketing development (e.g., through Patent Exclusivity expiration).

• Thorough understanding of legal, compliance, and regulatory guidelines related to the conduct of a variety of research trials in the pharmaceutical industry.

• Knowledge of pertinent external guidelines related to research and publications, and current standards of practice.

• Minimum of 6 years of managing teams in a matrix team environment.

• Strong communication and strategic skills; demonstrated ability to identify opportunities for medical engagement and develop a set of strategic scientific engagement/ research goals.

• Clear understanding of health services research / research methodologies and a demonstrated ability to translate real-world evidence.

• Experience operating in a highly dynamic, changing environment.

• Ability to maintain a command of a large amount of scientific information across multiple therapeutic areas and show effective written/verbal communication skills.

Travel requirements:

• Ability to drive to or fly to various meetings.

• Overnight travel may be required (10-30%), including some weekend commitments.

• Limited international travel may be required.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

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.

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U.S. Base Salary Range:

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.

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Job Exempt