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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%.
A competitive remuneration package with a minimum salary of € 6.244,19, - gross per month (full-time, collective wage agreement for the chemical industry, 14x) - the actual salary is higher and depends on your professional experience and qualifications.
Awarded Great Place to Work and certified family-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.
AUT - Wien - DC Tower
Employee
Regular
Full time
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