Scientific Director Dengue応募後で応募 求人ID R0033259 掲載日 06/15/2021 Location:Zurich, Switzerland; Boston, Massachusetts
- This position provides global scientific/clinical expertise to the Clinical Program Team (CPT) and to the Global Program Team (GPT) for assigned vaccine(s).
- The scientific director is accountable to the Medical/Sr. Medical Director for in-depth knowledge and understanding of disease(s), clinical trial design and management, and clinical strategy for the assigned clinical program and study(ies).
- Manages the clinical development program (CDP) development and update process and clinical program timelines as well as alignment with GPT and global program timelines.
- Frequently works with global cross functional teams, distilling complex data to resolve issues in accordance with the clinical development plans.
- Management of clinical program timelines and coordination across assigned clinical project(s).
- Management of cross functional CDP processes, including endorsement at GPT and approval at CDP approval committee.
- Coordination with the GPT and GPT project manager to assure alignment of clinical program with global program timelines.
- May be a member of GPT.
- Supports or leads clinical program and budget timeline discussions.
Clinical Program Team Participation and Leadership
- May lead the global clinical trial/ program level scientific and clinical activities for assigned compounds. Emphasis will be on ensuring that the development teams are proactively identifying contingencies, potential risks and strategies to address future obstacles.
- Supports the Medical/Senior Medical director in Clinical Program/ Development Team strategy and deliverables overseeing the Development Strategy, Clinical Development Plan and Clinical Protocols.
- Supports the Medical/Sr. Medical Director in responsibility for high impact global decisions and support of required internal governing bodies approval, 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 labelling.
Synopsis / Protocol Development, Study Execution, & Study Interpretation
- For assigned compounds, drives all Clinical Development activities relating to the preparation / approval of Synopses, Protocols and the conduct of clinical studies.
- May serve as a scientific advisor to other clinical scientists involved in these activities, and is accountable to senior company management for the successful completion of underlying objectives.
- For the assigned compounds, is accountable for the successful completion of projects undertaken - and for pro-active contingency planning / interventions necessary to ensure achievement of related goals.
- Interprets data from an overall scientific standpoint as well as within the context of the medical significance to individual patients, may present at scientific meetings and congresses.
- Presents study conclusions to Management and determines how individual study results impact the overall compound strategy.
Process Development and Management
- Supports portfolio management and monthly reports.
- Support Quality management system, SOP review and audits.
- Establishes, maintains and directs interactions with key opinion leaders relevant to assigned products.
- Supports clinical program level activities for interactions with regulatory authorities/agencies and key opinion leaders relevant to the clinical development of assigned compounds.
- Collaborates with the Medical Director / Senior Medical Director in the development of clinical sections of program level regulatory documents.
Due Diligence (DD), Business Development and Alliance Projects
- Supports the Medical Director / Senior Medical Director in the evaluation of potential business development opportunities with regard to clinical development.
- May assess 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 clinical science on internal assessment teams.
- May serves 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. Provides guidance to clinical scientists who are involved in some of these activities.
Leadership, Task Force Participation, Upper Management Accountability
- Interacts directly with research division based on pertinent clinical and development expertise and with the division to provide knowledge/understanding of market environment in line with status as the Vaccines scientific content matter expert for assigned compounds.
- Represents clinical development on high impact/priority task forces across the organization or external to the company.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Education and Experience
- Bachelors required with 15 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of the aforementioned) and professional license.
- Masters in Sciences preferred with 13 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of the aforementioned).
- PharmD preferred with 12 years of clinical research experience within the pharmaceutical industry, CRO health-related consulting company, or biomedical/clinical experience within academia (or a combination of the aforementioned).
- PhD in a related scientific discipline preferred with 10 years of clinical research experience within the pharmaceutical industry, 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 with responsibility for multiple studies. Global experience preferred.
- 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.
- Therapeutic area knowledge relevant to mechanisms of action of compounds in remit.
- Regional/global regulatory requirements.
- 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. Some international travel may be required.
- Requires approximately up to 20% travel.