The Sr. Medical Director, Japan is the leading country medical position in Japan, accountable for informing and delivering the Medical Affairs strategy related to licensed vaccines and candidate vaccines still in development. Initially, the role will be focused on supporting the rollout of a COVID-19 Vaccines. This individual will help build out the Japanese Medical Affairs strategy for the Infectious Disease franchise and eventually other products in development. To fulfill these objectives, the person in this role will partner and work closely with numerous external and internal stakeholders across the company, foremost the Japan General Manager and the leadership team, as well as regional and global colleagues within Medical Affairs and Research and Development.
S/He will be a key driver in establishing Japanese presence and will contribute to developing the excellence and scientific leadership of Medical Affairs organization. S/he will be responsible for proactive and continuous assessment of the dynamics of the external and internal environment and, as needed based on this assessment, develop and implement strategic plans to establish and evolve local Medical Affairs teams and ways of working.
Here’s What You’ll Do
- Be the head of medical affairs in Japan to include oversight of medical strategy, information for providers, data generation, medical policy, and engagement of Japanese medical and scientific leaders.
- Have oversight of Japanese pharmacovigilance and regulatory activities
- Strategic development, execution and delivery of regional Medical Affairs plans including tactical deliverables such as scientific exchange, support for clinical trials and real world evidence (when requested), post-licensure research, publication plans, investigator-initiated studies, and other knowledge transfer activities
- Build and maintain a network of key scientific leaders in areas of relevance to the current and anticipated needs.
- Develop and/or foster relationships with external stakeholders to ensure that robust local insights from healthcare practitioners and patients, enabling the generation of data that are needed to properly understand and value our innovative medicines and vaccines
- Planning of effective medical education campaigns, scientific advisory boards, KOL engagements, webinars and presentations to develop an effective scientific engagement strategy for Japan.
- Ensure alignment of the regional Medical Affairs plans with global strategy and adherence to all relevant regulations and SOPs
- Participate in outcomes research/health economics engagements with national payers, Health Technology Assessment or regulatory agencies, in coordination with Real-World Evidence, Market Access and Commercial colleagues
- Compliant management of compassionate use requests, pre-licensure patient access programs, patient access/support programs and similar activities
- Management of the approved operating administrative (i.e. salaries and travel) and life cycle management budget (i.e. Advisory boards, local data generation, etc.)
Here’s What You’ll Bring To The Table
- M.D. or equivalent degree from a recognized Medical School. Additional advanced degrees, entry on a Specialist Register (Pharmaceutical Medicine or a relevant clinical specialty) and a current license to practice are a strong plus
- Minimum 10 years of experience in global pharmaceutical industry in Clinical Development and/or Medical Affairs with demonstrated successful track record
- Track record of successful leadership, including training and developing talent, creation of a high performing team
- Demonstrated effective organizational skills, including ability to set goals and align priorities
- Experience in vaccines is strongly preferred
- Strong understanding of the compliance environment in which Medical Affairs functions
- Excellent written and oral communication skills.
- Highly effective leadership, and a strong willingness to collaborate with other functions.
- Fluency in English and Japanese.