Join a Legacy of Innovation 110 Years and Counting!
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
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.
- 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.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
- A full medical degree (MD) with board certification in internal medicine and with solid hands-on experience in all aspects of the designing, implementation, execution, and data dissemination of multinational clinical trials of various complexities and sizes; required
- With a track record of peer-reviewed publications as a lead author in internationally acknowledged journals. required
- Advanced training in a sub-specialty such as but not limited to endocrinology or immunology; required
- 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; required
- 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 required
- Basic knowledge and appropriate application of biostatistics; required
- Versed in GCP, ICH, CONSORT, and publication guidelines; required
- Advanced presentation skills as evidenced by numerous talks in front of audiences of different types (e.g., educational levels, medical specialties, conferences) and sizes; required
- 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; required
- Experience in setting and adhering to project budgets. required
- Experience in rare diseases required
Is willing to participate in virtual meetings outside the regular business hours and to travel domestically and internationally up to 25% of Time
Travel Ability to travel up to 25% Domestic and International Travel
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.