Global Medical Lead Entyvio

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’s Privacy 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

About the role:

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as a Global Medical Lead Entyvio where you will lead GMA-driven evidence generation, taking into consideration the medical, scientific, regulatory, and commercial issues. Lead a multi-disciplinary, multi-regional, matrix team through highly complex decisions. This individual has the ultimate responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a GMA Phase IIIb / Phase IV studies. Develop synopses and protocols for Phase IIIb / Phase IV studies. Provide Medical oversight and monitoring for Phase IIIb / Phase IV studies.

You will also be a member of the Global Medical Strategy Team and sub-teams. Partners with other MST members and Commercial and Clinical stakeholders in establishing a medical strategy wholly aligned with the cross-functional plan. Develop and maintain relationships externally through Advisory Boards, Professional Associations, Patient Advocacy, Professional Meetings and Conferences, and regular HCP scientific exchange, etc. to achieve Takeda’s scientific objectives. Manage budget for specific cost centers and provide direction and budget oversight.

As part of the Global Medical Entyvio team, you will report to Global Medical Lead Entyvio.

How you will contribute:

• Lead clinical trial and study-related activities. Contributes to Phase IIIb/IV research and RW data generation plans aligned with brand and market access strategy.
• Focus on Entyvio and IBD phase 3b/4 studies.
• Acts as a Medical Lead for the GMA Medical Affairs Company Sponsored / Collaborative studies.
• Drives clinical science activities relating to the preparation/approval of synopses, protocols, and the conduct of clinical studies. Accountable for the successful design and interpretation of clinical studies. Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
• Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
• Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and compounds in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to the assessment of these issues.
• Makes final decisions regarding study conduct related to scientific integrity.
• Directs activities involved in interactions to establish and maintain strong relationships with key opinion leaders relevant to Entyvio and IBD. These responsibilities include leadership roles in meetings with the key opinion leaders, establishment of a strategy for Entyvio, and also developing documents required to outline the Company's positions on research programs e.g. materials used for meeting presentations and formal responses to communications received from the regulatory organizations or opinion leaders. Lead roles will also be taken on the incorporation of advice/recommendations received into the design of clinical studies/programs as appropriate, accountable to senior leadership for the successful completion of related objectives.
• Core member of the Medical Strategy Unit (MST), contributing to the Global Product Medical Plan and its implementation. The Medical Strategy Unit (MST) comprises of experts from the therapy area medical group and functions such as strategy, project management, publications, research, medical information, etc.
• Partners with the Commercial and Clinical stakeholders in establishing a medical strategy that is wholly aligned with the brand plan.
• Drives, articulates, and socialize an ongoing data-driven “context check” to frame key data releases, extract and exploit value, and pre-identify and address data gaps supporting both assets and disease area assumptions (related to the context).
• Responsible for driving alignment on medical content/messaging within the organization to ensure maximal functional and regional input.
• Participate in the scientific communication plan, and further development of the publications strategy for assigned compounds by providing scientific input, in collaboration with the publications team, external experts, authors, and the internal team.
• A strategic approach focused on improving Takeda’s impact of activities addressing diversity, equity, inclusion, and health equity across the therapeutic area or portfolio.
• Contribute through both strategic internal and external medical education support, medical/scientific information exchange and support, as well as use medical/scientific expertise to gather medical/scientific insights supporting research/data generation activities.
• Represents GMA supporting "Disease Area Strategies."
• Supports Access teams with medical/scientific expertise.
• Contributes to creating the Asset Medical Strategy document with input from the Regional/Local Operating Company Medical Directors.
• Provides functional leadership to contribute to the successful launch and life cycle management of a prioritized global brand.
• Responsible for review and certification of assigned brand-related clinical content material development for medical education, medical communication, publications, and Key Opinion Leader (KOL) engagement plans.
• Provides medical-scientific training to internal/external stakeholders as required.

Minimum Requirements/Qualifications:

• MD required, Ph.D. is a plus, preferably a minimum of 5 years total pharma industry experience. At least 3 years of demonstrated clinical research experience within the pharmaceutical industry, CRO health-related consulting company, and/or biomedical/clinical experience within academia).
• Previous experience successfully leading a phase III/IV studies matrix team with responsibility for studies in multiple regions, and/or management experience
• Experience in synopsis/protocol writing and Medical Monitoring.
• Knowledge of clinical operations and at least 3 years of experience working in the area of immune-mediated disorders, and experience in Inflammatory Bowel Disease is desirable.
• Experience working on Global Products, engaging with International KOLs, and delivering a multinational value proposition for the assigned product.
• Demonstrated ability to work effectively in complex matrix environments.
• Deep knowledge of pharmaceutical industry dynamics and trends including a good understanding of the life cycle of a brand from cross-functional perspectives (e.g. marketing, pricing, reimbursement, supply chain).
• Excellent oral, written, and presentation skills, including proven success in communicating ideas to build collaborative work relationships.
• Advanced interpersonal and negotiation skills including clear achievements in positively influencing key stakeholders.
• Ability to proactively predict issues and solve problems.
• Ability to drive decision-making within multi-disciplinary, multi-regional, matrix teams.
• Diplomacy and positive influencing abilities.
• Fluency in English.
• Proven experience in and understanding multiple regional/country markets.
• Deep understanding of the brand(s)/therapeutic area and the stakeholders’ needs.
• Fluency in more than one language.

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and a company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

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.

Base Salary Range: $ 217,000 to $ 310,000, based on the candidate's professional experience level. Employees may also be eligible for Short-term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program, and Paid Volunteer Time Off.

The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

#RM-LI

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

Boston, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time