- The Medical Director leads and drives strategy for parts of the clinical development program or overall global clinical development for Takeda vaccine candidate(s) or aspects thereof, taking into consideration medical, scientific, regulatory and commercial issues.
- Leads a multi-disciplinary, multi-regional, matrix team through complex decisions. This individual has the expertise for development decisions assessing and integrating the input from various disciplines to create, maintain, and execute a global clinical development plan that will result in the regulatory approval of the assigned area in multiple regions.
- Applies clinical/medical decision making to clinical development issues.
- Supports the Senior Medical Director in the administrative and operational requirements of the clinical development team and in people management where appropriate.
- This individual influences clinical development decision-making by supporting strategic direction. Success or failure directly translates to the ability of VBU to meet its corporate goals and for Takeda to have future commercial products.
Clinical Development Team Participation and Leadership
- Supports Leadership of the global clinical development team for assigned vaccines. For a given vaccine, may lead the clinical program team and may represent clinical development on the global program team to ensure that activities are aligned with the global strategy. Emphasis will be on ensuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
- For assigned vaccine or aspects thereof, directs clinical development team strategy and deliverables overseeing the development strategy, clinical development plan and clinical protocols. Recommends scope, complexity and size, which influence the budget of assigned aspects of a program. Provides continual critical evaluation of the development strategy to maintain a state-of-the-art development plan that is competitive and consistent with the latest regulatory requirements, proactive identification of challenges, and development of contingency plans to meet them.
- Responsible for global decisions: monitoring and interpreting data from ongoing internal and external studies, assessing the medical and scientific implications and making recommendations that impact regional and global development such as go/no go decisions or modification of development plans or study designs that may have a significant impact on timelines or product labeling. Plans clinical development strategies in context of medical/clinical significance considering how a given product will fit in with current treatments, standard of care, and unmet medical need.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- Drives all clinical development activities relating to the preparation / approval of synopses, protocols and the conduct of clinical studies. Serves as an advisor to the Associate Medical Directors involved in these activities.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients.
Trial Medical Monitoring
- Oversees medical monitoring activities, assessing issues related to protocol conduct and/or individual subject safety. Assesses overall safety information for studies and vaccines in conjunction with Pharmacovigilance.
- If not qualified as a medical doctor (MD), the Associate Director will delegate responsibilities to MD colleagues, where applicable.
- Directs activities involved in interactions with regulatory authorities/agencies and clinical development and key opinion leaders relevant to assigned vaccines. Provides leadership and serves as an advisor to the other clinical program and trial team members engaged in these activities and, in the context of these responsibilities, will be accountable to senior leadership for the successful completion of related objectives.
Due Diligence (DD), Business Development and Alliance Projects
- Responsible for evaluation of potential business development opportunities with regard to clinical development. Assesses scientific, medical, and development feasibility, evaluating strategic fit with overall portfolio, evaluating complete or ongoing clinical trials, assessing regulatory interactions and future development plans, interacting with upper management of potential partner/acquisition companies during DD visits and alliance negotiations, and representing VBU clinical development on internal assessment teams.
- Serves as clinical contact point for ongoing alliance projects and interfaces with partners to achieve Takeda s strategic goals while striving to maintain a good working relationship between Takeda and its partners.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with internal and external partners based on pertinent clinical and development expertise and with the business unit to provide knowledge/understanding of market environment in line with status as the Vaccines scientific content matter expert for assigned vaccines. Represents clinical development on high impact/priority task forces across the organization or external to the company.
- Hires, manages, mentors, motivates, empowers, develops and retains staff to support assigned activities. Conducts performance reviews and drives goal setting and development planning.
- For the assigned vaccines, the Medical Director is accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience
- Medically-qualified candidates: MD or internationally recognized equivalent plus 5+ years of relevant experience, preferably within the vaccines industry.
- Previous experience of successfully leading a clinical development team/matrix team with responsibility for studies in multiple regions.
- New drug application/marketing authorization application/regulatory 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.
- Therapeutic area knowledge relevant to mechanisms of action of vaccines in remit.
- Regional/global regulatory requirements.
- Emerging research in designated therapeutic area.
- 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 20% travel.
Empowering Our People to Shine
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