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GMA Medical Unit Lead: PDT RAID

Company: Takeda
Location: Cambridge
Posted on: November 20, 2023

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'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

OBJECTIVES/PURPOSE

  • Leads development and execution of multi-year global medical strategy for Rare Autoimmune Diseases (RAID), appropriately aligned with overall strategy and incorporating PDT R&D functional strategies (e.g. clinical, regulatory, GEO, safety, compliance)
  • Leads the Global RAID Medical team for the product/disease area
  • Responsible for development and in-year implementation of the global medical plans in collaboration with the regional and LOC partners
  • Serves as the global expert within PDT in support of the product/disease area including the respective expanded access strategy

    ACCOUNTABILITIES

    • Leads the Global RAID Medical team for the product/disease area
    • Leads development and execution of multi-year global medical strategy for the specified Rare Autoimmune Diseases(RAID):
    • scientific communicaiton and education strategy e.g. publications strategy, congress strategy, HCP interaction strategy, and the scientific communication platform for the disease area / brand(s);
    • evidence generation: developing integraed evidence generation strategy, phase IV studies, registries, investigator initated research, participate in designing clinical development strategy and and study designs;
    • External Expert engagement: HCP interaction strategy, Scientific societies interaction;
    • Internal capacity building: sceintific training strategy and execution appropriately aligned with overall strategy and incorporating R&D and cross-functional strategies (e.g. clinical, regulatory, GEO, safety, compliance)
    • Acts as a senior company representative interacting with external scientific leaders, patient organizations, scientific societies and/or regulatory authorities as appropriate
    • Responsible for development and in-year implementation of the global medical plans supporting global medical strategy in collaboration with the regional and LOC partners (e.g. publications, medical communications, medical training, evidence generation) Input to development and management of the PDT R&D medical budget, responsibility for the product/disease area medical budget
    • Establishes appropriate strategic partnerships with centers of excellence and health care professionals (HCPs) in areas of scientific interest
    • Collaborates with Legal, Compliance and Regulatory to ensure proper and ethical interactions between PDT Global Medical Affairs personnel and external stakeholders
    • Contribute to PDT Global Medical Affairs Strategy by providing deep medical/ clinical expertise in the particular disease area
    • Planning, designing and managing PDT global medical Advisory Boards as appropriate
    • Providing medical review and approval of Investigator Initiated Research (IIR) proposals and other grants through the grant approval process
    • Leading design and execution of medical affairs company-sponsored and collaborative studies (phase IIIb/IV, disease registries, observational, noninterventional, epidemiological, outcomes surveys, etc.) in close collaboration with Therapeutic Area Unit representatives and Global Clinical Operations
    • Monitor and communicate progress against medical plan; propose and initiate initiatives as need to adjust to disease area requirements

      DIMENSIONS AND ASPECTS

      Technical/Functional (Line) Expertise
      • Comprehensive understanding of the pharmaceutical industry and Medical Affairs (e.g. Publications, Med Info, Knowledge systems, evidence generation, etc.)
      • Global medical affairs expertise with demonstrated strong ability for collaboration and team
      • leadership; experience leading and working with cross-cultural teams
      • Ability to think strategically from a medical perspective about how to medically appropriately support the growth of a medication
      • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
      • Proven skills as an effective team player who can engender credibility and confidence within and outside the company

        Leadership
        • Demonstrated ability to work in a global environment, across functions, regions and cultures
        • Enterprise level leadership with the ability to inspire, motivate and drive results
        • Leadership presence and confidence
        • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviours for the organization
        • Demonstrated business acumen
        • Ability to successfully influence and negotiate across and outside of the organization

          Decision-making and Autonomy
          • Demonstrated business acumen
          • Excellent decision-making capabilities, ability to make complex decisions that impact the department/PDT R&D
          • Ability to incorporate feedback and ensure decisions are made swiftly to yield flawless execution

            Interaction
            • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
            • Ability to effectively implement PDT R&D's partnership strategy
            • Ability to build strong partnerships and drive role clarity with other interfacing Takeda functions, including but not limited to GMA CoE, GPSE, LOC, Market Access, GOR

              Innovation
              • 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 take risks implementing innovative solutions, accelerating time to market
              • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
              • Accountable for designing and implementing vision and strategy for designated scope

                Complexity
                • Ability to distil complex issues and ideas down to simple comprehensible terms
                • Ability to work in a global ecosystem (internal and external) with a significant degree of complexity
                • Breadth of knowledge required across therapeutic areas, indications, and/or modalities
                • Experience operating in a multi-disciplinary drug development environment including international experience and exposure to a variety of therapeutic areas.

                  EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

                  • A medical degree (MD), PharmD or country specific equivalent is required
                  • Clinical experience in neurology is required, in Immunology is a plus
                  • Experience in launching in rare disease (i.e. neurology and/or immunology) is required
                  • > 5 years of experience in pharmaceutical medicine/medical affairs
                  • > 3 Years experience in global/international medical affairs is required
                  • Experience leading teams is required
                  • Experience in field-based roles (e.g. Medical Director, Medical Science Liaison) is a plus
                  • Experience in clinical development is a plus

                    ADDITIONAL INFORMATION
                    • Availability to travel up to 30% of time
                    • Some activities may call for early or late meetings and attendances at scientific meetings on holidays and weekends

                      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 company match of charitable contributions
                      • Family Planning Support
                      • Flexible Ways of Working
                      • 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.

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

                        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

                        Cambridge, MA

                        AUT - Vienna - K--rntner Ring

                        Worker Type

                        Employee

                        Worker Sub-Type

                        Regular

                        Time Type

                        Full time

Keywords: Takeda, Cambridge , GMA Medical Unit Lead: PDT RAID, Healthcare , Cambridge, Massachusetts

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