Senior Medical Director, Global Specialty Medical Affairs Rare Diseases (m/f/x)

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Date: 23-Jun-2022

Location: Munich, Germany, 81379

Company: Daiichi Sankyo Europe

 

Passion for Innovation. Compassion for Patients.

 


Daiichi Sankyo and its 16,000 employees in more than 20 countries are dedicated to the creation and supply of innovative pharmaceutical products. In Europe, we focus on two areas: In the cardiovascular space, our strong portfolio of medicines reflects our long-standing commitment and shows that we care for every heartbeat; in oncology our goal is to become a global pharma innovator until 2025 by providing novel therapies to patients across the world. Our European headquarters are in Munich, Germany, and we have affiliates in 13 European countries. For more information: www.daiichi-sankyo.eu.

 

For our headquarter in Munich we are seeking highly qualified candidates to fill the position:

 

Senior Medical Director, Global Specialty Medical Affairs Rare Diseases (m/f/x)


The position:

The major objective is to lead and support the implementation of the overall global medical affairs objectives for Specialty & Value Products (S&VP) therapeutic area, specifically for the assigned product(s), i. e. edoxaban. The Senior Medical Director will provide medical scientific and operational know-how, leadership, and direction to execute the defined global medical affairs projects in line with the strategic objectives for the S&VP products, most importantly edoxaban. Medical leadership of the edoxaban life cycle program, including global clinical studies, non-interventional studies, registries, investigator initiated studies (IIS), and medical communication and publication activities (including scientific symposia, advisory boards, authoring publications, medical education and training) are key activities. In collaboration with the operational and medical affairs teams in the regions, the Global Senior Medical Director will assume accountability for the timely planning, implementation, completion, and finalization of the studies and registries under her/his responsibility. In this role, execution of scientific projects at the highest scientific and technical level by managing internal and external partners under consideration of regional guidelines is of importance. Medical scientific communication and collaboration with internal functions and across geographies and with external partners (investigators, key external experts, regulators, CROs etc.) representing GMA S&VP is a critical part of the job. The Senior Medical Director represents the GMA S&VP function towards internal and external stakeholders as the deputy for the department head.

 

Responsibilities:

  • Represents GSMA in committees and meetings related to rare disease providing the clinical and medical affairs perspective
  • Co-develops with GSMA MI&E Head the medical strategies for Life Cycle Management (LCM) of rare disease products, Publications and Communication, Medical Information and Education taking into consideration regional and country needs
  • Takes the lead and responsibility in assigned phase 3 b/4 studies including registries. Coordinates scientific projects with regional medical affairs and supporting departments cross-functionally. Takes responsibility for communication of the progress and results of the projects to internal and external stakeholders in alignment with R&D and the GSMA Publications Lead
  • Serves as the GSMA expert for the new compounds for rare disease under evaluation in research and development and provides the clinical and medical affairs perspective through acquisition of the most updated knowledge by such as identifying and interacting with KEE and participation in conferences. Will impact all clinical trials of rare disease projects including such as first in human and proof of concept
  • Supports GSMA Head in shaping the capabilities of Global Specialty Medical Affairs for rare diseases. The scope includes framing of the organizational structure, capabilities, and filling potential gaps


Experience Qualifications:

  • Advanced training in a sub-specialty such as but not limited to endocrinology or immunology
  • At least 10 years of experience in clinical medicine and clinical research in an academic environment OR minimum 5 years hands-on clinical research in the pharmaceutical industry
  • Knowledge of scientific methods, study designs, and medical practices and procedures that will be acquired on a global level including phase 3b/4 studies and registries
  • Basic knowledge and appropriate application of biostatistics
  • Versed in GCP, ICH, CONSORT, and publication guidelines
  • Advanced presentation skills as evidenced by numerous talks in front of audiences of different types (e.g., educational levels, medical specialties, conferences) and sizes
  • Advanced and solid writing skills of scientific documents (in English) as proven by a track record of study documents such as protocols and study reports
  • Experience in setting and adhering to project budgets
  • Experience in rare diseases
  • Ability to travel up to 20 % (Domestic and International Travel)

 

 

What we offer


Working at Daiichi Sankyo

At Daiichi Sankyo in Europe, we offer a workplace where your voice is heard. Everything we do, we do with a high level of commitment and a clear focus on patients’ needs. We know that our bold ambition to change patients’ lives for the better can only be achieved through the power of collaboration and the exploration of new approaches. Thus, we encourage our colleagues across Europe to be courageous, to bring their ideas to the table and to embrace opportunities to grow. When you join our European family, you will be a part of a dynamic company where everyone, no matter their role, rolls up their sleeves and gets things done.