- Director level role driving strategy for clinical development activities for Takeda Vaccines in the assigned geographical region, taking into consideration both local/region and global medical, scientific, operational, regulatory and commercial matters.
- The 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 organization s global development objectives and ultimately business objectives.
- Serve as key contributor to clinical documents, including clinical trial documents, reports and publications and integrated clinical documents for regulatory submissions, as well as external presentations.
Clinical Development team participation
- Ensure 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.
- Work in a matrix team with other colleagues (other clinicians, statisticians, clinical trial and program managers ...), to ensure that the development teams are proactively identifying contingencies, potential risks and strategies to address future hurdles.
- 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. Support continuing evaluation of the strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements with proactive identification of challenges, and development of contingency plans to meet them.
- Contribute to regional decision making: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional development. Considers how a given product will fit in with current treatments, standard of care, and unmet medical need i. e. medical/clinical significance.
- Co-lead in the country and site/investigator selection process
- Co-lead in feasibility assessment at regional and country level, also provide input into the study protocol as it is developed.
- Provide medical input in regional/local study documents for submissions (ICF, information letters, etc) and overall medical advice to the Development Delivery Group.
- Take the lead in managing critical issues (which have a time/budget/relationship impact) linked to the investigator and his/her team and if appropriate manages the escalation process.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Support Clinical Development activities and clinical development plans, clinical trial protocols designs, Clinical Study 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
- Support preparation of study budgets and internal budgets
- Has the co-responsibility for quality of all related clinical trial documents
- Review appropriate documents prepared for the submission package according to local regulations (e. g. submissions to Health Authorities and Ethics Committees)
- Responsible for identification of and contact with potential sites and negotiation of budget proposals
- Interpret data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
- Responsible for the interaction with study investigators and presents clinical trial results.
- Liaise with Pharmacovigilance (PV) to develop RMPs (Risk management plans), Core safety data sheets and serves on SMT (safety management team). In clinical trials, together with PV, analyze potential safety signals and escalate accordingly.
Trial Medical Monitoring
- Oversee medical monitoring activities (including but not limited to Data Listing review for the medical portion of data listing), assure medical consistency within a trial and across trials within a program, assessing issues related to protocol conduct and/or individual subject safety. Assess the overall safety information for studies and vaccines in conjunction with Pharmacovigilance. Pay special attention to serious adverse events, pregnancies, AESI s (adverse events of special interest) and potential safety signals.
- Serve as a counterpart of vendor physicians to ensure alignment of clinical trial activities (including, but not limited to, scientific and medical issues as well as subject safety)
- Understand clinical development global strategy and translation into region including CDPs and protocols
- 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.
- Support of country/region specific medical affairs activities as appropriate
- 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.
KOL and Investigators management
- Responsible for setting-up, developing and managing a regional network of KOLs and Investigators who will successfully support development of Takeda s key products candidates in the region.
- Supports Regional/Local Scientific and Clinical Advisory Board Meetings.
- Supports 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 postmarketing commitment trials.
- Responsible for the oversight of Investigators Initiated Studies in the assigned region.
- Provide 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.
- 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
- Assesses scientific, medical, and development feasibility, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans.
- 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.
- As the vaccines business grows, the individual 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 vaccine business unit
- Is an advocate of Takeda s values internally and externally
- As appropriate mentors, motivates, empowers, develops and retains staff to support assigned activities.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Medical Degree 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 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
- Emerging research in designated therapeutic area
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to drive to or fly to various meetings or client sites, including overnight trips. International travel will be required.
- Requires approximately 10-15 % travel
Empowering Our People to Shine
Learn more at takedajobs.com.