Job Title Regional Medical Director, Vaccine Business Division (North America)
Job Profile Regional Medical Director, Vaccine Business Division (North America)','1400571','!*!OBJECTIVES:
The Regional Medical Director leads and drives strategy for the clinical development and medical affairs activities in his/her assigned geographical region, taking into consideration both the local/regional and global medical, scientific, operational, regulatory and commercial matters.
Leading a multi-disciplinary, matrix team through highly complex decisions, this individual has the required development expertise and is able to integrate the input from various disciplines to help create, maintain, and support the execution of the global development plans in the region that will support the company’s global development objectives and ultimately business objectives. This individual influences VBD senior leadership decision-making by incorporating regional/local needs in the global development strategies.
KOL and Investigators managementResponsible for setting-up, developing and managing a regional network of KOLs and Investigators who will successfully support development of Takeda’s key vaccine candidates in the region.In collaboration with the program team, sets-up and participates in Regional/Local Scientific and Clinical Advisory Board Meetings.Trial Medical MonitoringUnderstands clinical development global strategy and translation into region including CDPs and protocols.Oversees medical monitoring activities in assigned region, assessing medical issues related to protocol conduct and/or individual subject safety.In conjunction with Pharmacovigilance and the clinical program team, assesses overall safety information for studies and compounds in assigned region. Ad-hoc member of the Vaccines Safety Team.Clinical Development Regional OperationsEnsures that the regional/country medical needs and practices (current treatments, standard of care, unmet medical needs) are taken into account when elaborating global clinical development plans.Has a leading role in the country and site/investigator selection process as a member of the Trial Allocation Board. Leads the study feasibility assessment at the regional and country level, also providing input into the study protocol as it is developed.Provides medical input in regional/local study documents for submissions (ICF, information letters,…) and overall medical advice to the Development Delivery Group.Takes the lead in managing critical issues (which have a time/budget/relationship impact) linked to the investigator and his team and if appropriate manages the escalation process.Leads the regional development team (including the Development Delivery members. EpidemiologyProvides input in the global epidemiology plan making sure that the regional needs and specificities are taken into account.Participates in the initiation, set-up, oversight and reporting of country/region specific epidemiology trials in collaboration with the Development Delivery Group.Regulatory AffairsAttendance and participation in meetings with regulatory authorities/agencies in the assigned region/countries.Represents Takeda in relevant regional vaccine bodies for the region and pan region. Provides support for the preparation of regional section of central documents (DSUR, CTAs,…)Medical AffairsEnsures that the regional/country medical needs are taken into account when elaborating global Medical Affairs strategies.In coordination with Global Medical Affairs takes the lead for the set-up and management of a regional network of KOLs which will be instrumental in advising and supporting the adequate development of Takeda’s vaccines in the region.Provides support of country/region specific medical affairs activities as appropriate (Advisory Boards, pre-launch activities,…)IISR and Phase IV StudiesTakes the lead in the 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 IISR in the assigned region.Risk ManagementProvides continual critical evaluation of the regional development strategy to ensure that it remains competitive and consistent with the latest regulatory and medical guidelines requirements, proactively identifies challenges, and develops contingency plans to meet them.ComplianceEnsures 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 ProjectsResponsible for the evaluation of potential business development opportunities arising in the region with regard to clinical development.Serves as clinical contact point for new or ongoing regional alliances. Provides guidance to development team members who are involved in some of these activities.Leadership, Change managementAs the vaccines business grows, is able to adapt the regional structure over time and successfully manage a shift in priorities and focus. Is moreover able to seize regional growth opportunities to further develop the capabilities of the vaccines division.Is an advocate of Takeda’s values internally and externally.As appropriate, hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities.','!*!EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
MD or internationally recognized equivalent plus 5 years of clinical research experience within the Vaccines industry. Previous experience successfully leading a clinical development and medical affairs team/matrix team with responsibility for studies/activities in multiple regions. NDA/MAA/Submission experience preferred Experience with and demonstrated ability to lead and manage highly trained medical, scientific and technical professionals preferred
Superior communication, strategic, interpersonal and negotiating skills Ability to proactively predict issues and solve problems 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 GCP/ICH
Ability to drive to or fly to various meetings or client sites, including overnight trips. Some international travel may be required. Requires approximately 20% travel.
Takeda is an EEO employer of minorities, women, disabled, protected veterans. For more information, visit ****No Phone Calls or Recruiters Please.','Research and Development','US-IL-Deerfield','','Full-time','Regional Medical Director, Vaccine Business Division (North America)