Regional Medical Director
Regional Medical DirectorApply NowJob ID1602425Date posted10/12/2016LocationZurich, Switzerland;
With around 30,000 people working in approximately 70 countries we are a truly global partner for better health. Takeda is dedicated to pharmaceutical innovation and tackling diseases for which there is currently no cure. We are expanding continuously into new fields of treatment and therapy. By always putting people first, we empower employees so everyone can develop to his or her full potential. We are looking for colleagues with the right skills and experiences to support us in improving the quality of the most precious thing we know: life.
Clinical Development Team Participation
- Ensure that the regional/country medical needs and practices are taken into account when elaborating global clinical development plans.
- Work in a matrix team with other colleagues to ensure that the development teams are proactively identifying contingencies, potential risks and strategies
- Support the Development Strategy, Clinical Development Plan and Clinical Protocols. Recommend scope, complexity and size, which influence the budget of all aspects of a program.
- Considers how a given product will fit in with current treatments, standard of care, and unmet medical need
- Co-lead in the country and site/investigator selection process.
- Provide medical input in regional/local study documents for submissions
- Provide leadership to the regional development team (including the Development Delivery members).
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Reports and publications of high scientific, operational and ethical standards. Ensure consistency of data within program and across trials in the region.
- Support preparation of the Investigator Brochure and Common Technical Documents (including updates) and the Annual Safety Reports (DSUR and if applicable PSUR’s) to Regulatory Agencies as applicable.
- Supportive in clinical liaison to IDMCs.
- Interpret data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Liaise with Pharmacovigilance (PV) to develop RMPs (Risk management plans), Core safety data sheets and serves on SMT (safety management team).
Trial Medical Monitoring
- Oversee medical monitoring activities
- Assess the overall safety information for studies and vaccines in conjunction with Pharmacovigilance. Pay special attention to serious adverse events, pregnancies, AESI’s and potential safety signals.
- Serve as a counterpart of vendor physicians to ensure alignment of clinical trial activities -
- Attendance and participation in meetings with regulatory authorities/agencies in the assigned region/countries.
- Contribute to ensure the regional/country medical needs are taken into account when elaborating Medical Affairs strategies.
- In coordination with Medical Affairs, set-up and manage a regional network of KOLs which will be instrumental in advising and supporting the adequate development of Takeda’s vaccines in the region.
- Provide input in the epidemiology plan making sure that the regional needs and specificities are taken into account.
- Participate in the initiation, set-up, oversight and reporting of country/region specific epidemiology trials in collaboration with the Development Delivery Group.
- In collaboration with the program team, sets-up and participates in Regional/Local Scientific and Clinical Advisory Board
- Take the lead in initiation, set-up, oversight and reporting of country specific Phase IV trials.
- In collaboration with the Development Delivery Group, supports the set-up and medical oversight of post-marketing commitment trials.
- Responsible for the oversight of Investigators’ Initiated Studies in the assigned region.
- Provide continual critical evaluation of the regional development strategy, proactively identifies challenges, and develops contingency plans to meet them.
- Ensure that the medical activities in the region/country are compliant with all applicable local and regional regulations and obligations as well as in line with Takeda’s own Ethical Guidelines and Business Practices.
Due Diligence, Business Development and Alliance Projects
- Serve as clinical contact point for ongoing alliance projects and interfaces with partner to achieve Takeda’s strategic goals while striving to maintain good working relationship between Takeda and partner.
Leadership, Task Force Participation, Upper Management Accountability
- Interact directly with specific divisions based on pertinent clinical and development expertise to provide knowledge/understanding of regional market environment in line with status of the scientific content matter expert for assigned products.
- Medical Degree or internationally recognized equivalent with the relevant industry experience and 5 years of clinical research experience within the Vaccines industry or CRO health-related consulting company, or biomedical/clinical
- Experience within academia (or a combination of afore mentioned).
- Previous experience successfully leading a clinical development team/matrix team with responsibility for studies/activities in multiple regions.
- Experience and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals
- Superior communication, strategic, interpersonal and negotiating skills.
- Ability to proactively predict issues and solve problem.
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
- Diplomacy and positive influencing abilities across multinational business cultures.
- Vaccines, immunology, infectious diseases, public health.
- Regional/country medical and regulatory requirements and practices.
- Emerging research in designated therapeutic area.
- Ability to drive to or fly to various meetings or client sites, including overnight trips.
- International travel will be required - approximately 25-30 % travel.