JOB INFORMATION
求人情報

求人番号 79057-003

製薬・医療機器業界

日系 メディカル

Associate Director, R&D Marketed Products, Therapeutic Area Strategy Unit

  • 年収
    非公開
  • 勤務地
    近畿
  • 英語力
    上級

製薬会社における【Associate Director, R&D Marketed Products, Therapeutic Area Strategy Unit/ 日本開発センター 領域戦略ユニット主席部員】のポジションです。

職務内容
■Marketed Product R&D support & Leadership
- Partner with R&D Marketed Product Project Manager to coordinate R&D function support for assigned products within the GPT or EPST. Provide clinical scientific leadership,expertise and execution for assigned products to support other R&D function leads within the team.
- Establish integrated partnership(s) with R&D functional leads on assigned team (regulatory affairs, pharmacovgilance, global development operations).
- Collaborates with the commercial organization and Established Products Team and Sub Teams to achieve team objectives
- Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders to support assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Medical Affairs (Global and Regional), Global Commercial, LOC MDs, Regional Business Units (e.g., product brand leads) and LOC product leads.
- Forms integrated partnerships with and works with Global Product Team Leaders (GPL) and Established Product Sub Team Project manager (EPST GPM) as necessary, and ensures excellence in delivery of clinical support and execution of clinical development activities/studies across assigned products. Works effectively to support GPT/EPSTs.
- Forms integrated partnership with strategic partner vendor(s) and provide oversight of all strategic partner vendor clinical deliverables for assigned products. Ensure highest quality of clinical science input and clinical components of deliverables from the strategic partner vendor.
- Partners with strategic partner vendor(s) and drives clinical scientific activities relating to the preparation / approval of protocols and the conduct of clinical studies to support LCM, post marketing requirements and regional or local registration as needed. Provides Takeda oversight of strategic partner MDs/clinical staff involved in these activities. Ensures the successful design, execution and interpretation of clinical studies.
- Oversees the strategic partner vendor(s) to ensure appropriate and continuous medical monitoring and medical data review of clinical studies, to ensure appropriate benefit/risk of subjects within the study. In collaboration with Medical Director, ensures internal oversight of strategic partner vendor medical monitoring activities, assessing issues related to protocol conduct and/or individual subject benefit/risk. Participates in assessment of overall safety information for studies and compound in conjunction with Pharmacovigilance. Participates in making final decisions regarding study conduct related to scientific integrity
- Establish integrated partnership with strategic partner clinical operations and statistical functional leads to ensure the integrity and correctness of data analysis and interpretation with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally in support of regulatory submissions, ensuring data quality and adherence to national and international regulations and requirements and ICH.
- Participates in cross functional non-project-specific initiatives and committees on behalf of project clinical perspective
- Participates in presentation of Presents study conclusions to management and determine how individual study results impact the product strategy. Participates in interpretation of data from an overall scientific and regulatory standpoint as well as within the context of the medical significance to individual patients
- Participate in and support all required regulatory submissions/interactions for assigned products. Represent Takeda as Responsible Clinical expert to regulatory agencies globally for assigned products as needed. Support Local Operating Company (LOC) medical/clinical staff for regulatory agency interactions for assigned products, as needed. Provides clinical scientific input and supports development of required documents for regulatory applications/submissions (e.g. briefing reports, CTDs, IND updates, PSUR updates, label changes etc.), materials used for meeting presentations, and formal responses to communications received from the regulatory agencies.
- Supports to provide scientific education and mentoring for internal and external audiences (academic partners, scientific community)
- Oversee compliance with internal SOPs and external legal requirements, including training of assigned personnel, contractual arrangements with external service providers and partner companies.
■Japan specific product R&D support & Leadership
- Japan Development team (JDT) team leader and an expert of Clinical Science in JDT for the assigned marketed product or the assigned Japan specific newly developing product. Provide clinical scientific lead as well as exerting leadership as a JDT team leader in conducting and promoting clinical activities of the team partnering with Project Management.
- Establish integrated partnership(s) with R&D functional leads on assigned JDT such as regulatory affairs, pharmacovgilance, clinical operations, stats and with strategic partner vendor(s).
- In collaboration with Japan Business Unit (JPBU), participates from the aspect of Clinical Science in conducting and promoting clinical activities including life-cycle management to maximize the value of the assigned product(s).
- Form integrated partnerships and collaborate with all relevant cross-divisional stakeholders involved in the support of assigned products, including but not limited to, Quality, Global Manufacturing and Supply, Japan Medical Affairs.
- As a manager in MPG clinical science, provides advice to his/her direct report(s) on the task management, career development, education, etc.
■External Interactions
- Build and develop medical and clinical expert relationships to ensure delivery and maintenance of state-of-the-art medical therapeutic and clinical scientific expertise into medical and clinical R&D support for assigned marketed products
- Participates in meetings with regulatory agencies as required
■Due Diligence, Business Development & Alliance Projects
- Participate and conduct clinical due diligence evaluations and development of clinical development plans for potential alliances and or in-licensing opportunities.
- Assess both scientific 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 due diligence visits and alliance negotiations, and actively participating on internal assessment teams in conjunction with commercial colleagues.
応募条件
Requirement
<Education>
- Master's degree in life sciences (pharmacy, agriculture, physical chemistry, medicine, etc.)
- Bachelor's degree in pharmacy of 6-year system .
- 生命科学(薬学、農学、理化学、医学等)修士または6年制薬学部卒業以上の学歴を有する。
<Experience>
- Six or more years of clinical development experience within the pharmaceutical industry, CRO, health-related consulting company.
- Track record and demonstrated ability to lead and manage both science and business aspects of drug development.
- Experience with and demonstrated ability to lead and manage highly trained research, scientific and technical professionals
- NDA/MAA/Submission experience preferred
<スキル・資格>
- 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
- Knowledge for Regional/global Regulatory requirements
- Knowledge for GCP/ICH
<語学>
- English skill is required to use without problem in business and discussion with global employees
- Working experience in a global team or environment is preferable.
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