Clinical Programs Lead LOC の求人情報なら転職エージェントJAC


Clinical Programs Lead LOC

  • 転勤なし
  • 週休二日制
  • 上場
  • 外資



会社名 外資製薬メーカー <業種:メディカル・バイオ - 製薬>


雇用形態 正社員(期間の定めなし)
勤務地 東京都


This section focuses on the main purpose of the job in one to four sentences.

-The primary responsibility is to be the lead for all Local Country (LOC) study activities ( in JP PMS activities led by the GPSP person are out of scope) ) in Japan. This role in Japan is expected to oversee study activities related to global programs which JP joins (regardless international or local stand-alone study) and contribute to the global dossier.This role should contribute to the understanding of the JP needs and feed this information to the global CPM.The role holder assures the country Medical Affairs plans are visible to the global CD and CDO groups in a timely manner.The position holder is expected to drive communication between the local and global functions, guide on required processes and structure if there is a special need for a role, assure alignment with the compound/development and outsourcing strategy, support oversight of the selected vendor, drive appropriate quality of the local studies and work in closest collaboration with the global Program CDO representative aligned with the predefined RACI by giving input onto R&R for each study.

-Close collaboration and communication between stakeholders i.e. Drug Safety and Risk Management , Regulatory Affairs, MA, Patient Outcome, Clinical Development, Clinical Quality, External Partnerships and the CDO functions is expected.

-In Japan the role holder should support local RA with input into the development activities as needed, especially for JP stand-alone studies and support communication with the global teams. This is a focus of this role.

-Dependent on the stage of the life cycle of a compound the scope of oversight (of study and strategy) and interactions may vary.

<Essential Duties and Responsibilities>

This section contains a list of five to eight primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.

・Represent Clinical Development Operations (biostatistics, data management, clinical operations, and clinical scientific writing, outsourcing) on brand planning meetings and respective CD activities to support realistic budget, time, allocations.

・Assure full transparency of local studies to the global organization and work closely with the respective global functions.

・Works collaboratively with the GPSP representative and global program lead





To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

-Has working knowledge and familiarity with local country regulations including non-interventional studies.

-Understanding of Medical Affairs, Clinical plans including potential risks to facilitate decision making.

-Excellent verbal and written communication skills required. Strong interpersonal and organizational skills a must, able to navigate in a matrix organization.

-Possess working knowledge of research objectives, protocol design, data collection standards, epidemiology and clinical quality standards.

-Working knowledge of common office and scientific computer programs as Microsoft Word, Excel and Project.

-Must demonstrate leadership skills in order to direct country representatives , global CDO functions, MA etc. in study preparation and execution and to effectively communicate decisions.

-Curiosity for new set ups, able to deal with ambiguity and willing to listen to different interests.

-Ability to travel ca 20%of time.

<Education and/or Experience>

Include the education and experience that is necessary to perform the job satisfactorily.

-Scientific degree or equivalent experience (MS/MSc/PhD/). Must possess at least 8 years of clinical experience in the pharmaceutical or biotechnology industry in Japan including Development and Operations.


年収 1000万円 - 1500万円