Associate Medical Director Clinical Science (f/m/x)


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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Associate Medical Director Clinical Science in our Vienna office.
Here, you will be a vital contributor to our inspiring, bold mission.

The PDT BU 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 immunologic, hematologic, and other complex diseases.  The Head, Clinical Medicine, Plasma-Derived Therapies Business Unit will have the ability to create and define the future vision and operating model for the team.  There will be two main drivers of innovation in the newly-formed PDT R&D group:

  • Translational / Pharmaceutical Sciences: This innovation engine practices rapid-cycle innovation to test and develop improvements to existing products, develop new products, and improve yield. It combines translational research with pharmaceutical sciences and device, and receives inputs from and into clinical research and manufacturing sciences.
  • Precision Medicine / Integrated Care Solutions: This innovation engine focuses on developing comprehensive, value-oriented health care delivery packages around drug products, targeted to maximize benefit and reduce risk to precise patient populations. In the process, this engine drives innovation by practicing patient-centric R&D.

The Associate Medical Director leads and drives strategy for the overall regional (US/EU) clinical development in partnership with others, taking into consideration the medical, scientific, regulatory and commercial issues for assigned Takeda PDT R&D BU pipeline and inline products. Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership regionally and locally. This individual has the responsibility for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a clinical development plan that will result in the regulatory approval of the assigned product in multiple regions. Applies clinical/medical decision making to clinical development issues. This individual interacts with and influences PDT R&D leadership decision-making for the projects by setting strategic direction. Success or failure directly translates to the ability of PDT R&D to meet its corporate goals and for Takeda to have future commercial products.

Your Opportunity:

Clinical Development team participation and leadership

  • Represents Clinical Development for a given product and/or indication, and may represent Clinical Medicine on the Global (US/EU/Japan) Clinical Development Team to ensure that activities are aligned with the global strategy.
  • Responsible for development team strategy and deliverables producing the development strategy, clinical development plan and cinical protocols.  Recommends scope, complexity and size, and influence the budget of all aspects of a program.  Ongoing work output will involve continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them. Recommends high impact regional and global decisions. Responsible for 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 such as “go/no go” decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling.  A significant error in judgment may result in loss of approvability and/or commercial viability of a product.

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 involved in these activities, and is accountable for the successful design and interpretation of clinical studies.  Presents study conclusions to Management and determine how individual study results impact the overall product strategy
  • Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.

Trial Medical Monitoring

  • Responsible for medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and products in conjunction with Pharmacovigilance. Oversees non-medical clinical scientists with respect to assessment of these issues
  • Makes decisions regarding study conduct related to scientific integrity.

External Interactions

  • Directs activities involved in interactions with regulatory authories/agencies and clinical development and key opinion leaders relevant to assigned products in PDT R&D. Provides leadership and expertise in these activities, and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives. Leads incorporation of advice / recommendations received into the design of clinical studies and programs as appropriate.

Due Diligence, Business Development and Alliance Projects

  • Responsible for 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. Contributes to scientific, medical, and development feasibility by evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing clinical science on internal assessment teams
  • Serves as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda PDT BU R&D’s strategic goals while striving to maintain good working relationship between Takeda PDT BU and partner.

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 represent clinical science on high impact/priority task forces across the organization or external to the company.  May lead PDT R&D internal teams and global cross-functional teams, as appropriate.
  • May hire, manage, mentor, motivate, empower, develop and retain staff to support assigned activities. Conducts performance reviews and drive goal setting and development planning, as appropriate.

Your Skills and Qualifications:

  • MD or internationally recognized equivalent plus 3 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of aforementioned).
  • Previous experience successfully working in a clinical development team/matrix team with responsibility for studies in regions.
  • Knowledge in Immunology, Immunodeficiencies, or related specialties relevant to disease mechanisms and plasma derived/related therapies
  • Regional/global Regulatory requirements
  • GCP/ICH
  • Emerging research in plasma derived/related therapies
  • NDA/MAA/Submission experience preferred
  • Management experience preferred
  • Physician and Surgeon Medical License or equivalent
  • Board certification/s in related specialty area is desired

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer.

We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is 4 751,92 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

Locations

AUT - Wien - DC Tower

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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