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Plasma Derived Therapies Business Unit Research and Development (PDT R&D) group is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients' and health care providers' expectations with plasma-derived and plasma-oriented therapies for patients with serious, complex diseases.

The Medical Director - Immunodeficiency leads and drives strategy for the overall global (US/EU/Japan/other regions and countries) clinical development for assigned Takeda pipeline compounds in Immunodeficiency. The candidate will apply their clinical expertise development, taking into consideration the medical, scientific, regulatory and commercial

perspectives.

• Leads clinical development for a given product and/or indication and may represent Clinical Science on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.

• Establishes and drives development team strategy and deliverables producing the clinical development strategy, Clinical Development Plan and Clinical Protocols.

• Responsible for high impact global decisions with respect to Immunodeficiency: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development.

• Synopsis / Protocol Development, Study Execution, & Study Interpretation: drives clinical science activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to assoc. med directors and clinical scientists.

• Trial Medical Monitoring: responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety.

• External Interactions: directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D.

• Due Diligence, Business Development and Alliance Projects: Responsible for identification and evaluation of potential business development opportunities in PDT R&D, conducts due diligence evaluations, and development and negotiation. of clinical development plans for potential alliances and or in-licensing opportunities and serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D's strategic goals.

• Leadership, Task Force Participation, Upper Management Accountability: interacts directly with research division based on pertinent clinical and development expertise to provide knowledge/understanding of market environment in line with status as PDT R&D scientific content matter expert for assigned products. May also hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities

In this position you will report to the Head of Primary Immunodeficiency Clinical Science.

• M.D. or internationally recognized equivalent degree is required. Additional advanced degree, e.g. Ph.D. is desired.

• Clinical Immunologist or Allergy / Immunology Specialist or Internal Medicine Specialist is preferred.

• 3-5 years of strong clinical research/drug development experience within the pharmaceutical industry is required.

• Previous experience successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions is desired.

• NDA/MAA Submission experience is preferred.

• Knowledge/experience in Immunology, or a related specialty, disease mechanisms and plasma derived/related therapies.

• Regional/global Regulatory requirements.

• Management experience is preferred.

• Superior communication, strategic, interpersonal and negotiating skills

• Ability to proactively predict issues and solve problems

• Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams

• Diplomacy and positive influencing abilities

• Travel Requirement is approximately 10 - 20%.

For Location:

Cambridge, MA

U.S. Base Salary Range:

$237,200.00 - $372,790.00

• AwardedGreat Place to Workand certifiedfamily-friendly employer

• Flexible work models: hybrid working and flexible scheduling where possible

• Career growth & learning: comprehensive development programs, continuous training, mentoring, talent programs, and apprenticeships

• Internal mobility: opportunities for internal job rotations and cross-functional moves

• Recognition & rewards: employee referral and recognition programs, plus an employee stock purchase plan

• Inclusive culture & communities: active participation in employee networks (e.g., Diversity, Equity & Inclusion and Sustainability)

• Employee Assistance Program (EAP): confidential support provided by an external partner

• Health & wellbeing: wide range of health services, including free vaccinations, psychological counseling, and massages

• Fitness support: fitness offerings to help you stay active

• Community & team spirit: company events and celebrations throughout the year

• Great on-site amenities: company canteen with subsidized prices, Meal Allowances for locations without canteen

• Family support: company childcare / bilingual on-site daycare (company kindergarten)

• Easy commute: excellent public transport connections

• Convenient parking: free parking spaces available via booking app

• Sustainable mobility: company bike leasing program (JobRad)

Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide. Our passion and pursuit of potentially life-transforming treatments for patients are deeply rooted in over 240 years of distinguished history in Japan.

We want to improve people's health and create a better future for our world. We specialize in developing and manufacturing life-transforming medicines for people living with rare and complex diseases. We drive innovation and are pioneers in sustainable pharmaceutical production. In everything we do, patients, our employees, and the environment always come first.

Takeda is proud of its commitment to create a diverse workforce and to provide equal employment opportunities to all employees and applicants for employment without regard to ethnicity, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law. If you are living with disabilities, chronic illness, or neurodiversity, please feel free to let us know so that we can provide you with appropriate support during the application process.

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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:

U.S. Base Salary Range:

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-term incentives. 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.

Job Exempt