Associate R&D / Clinical Officer

Associate R&D/Clinical Officer
in charge of all therapeutic areas, especially Respiratory

Job Description

Associate R&D/Clinical Project Leader (A-PL) is an assistant manager position to oversee and coordinate R&D/Clinical projects with the Project Leader (PL). A-PL may perform his/her tasks with advice/instructions from PL and/or under supervision of PL (depending on his or her capability).

l In each assigned project, A-PL is responsible to generate and maintain local development strategy and project plan together with PL and Development Team Members, and to engage in project management activities.

l A-PL is requested to work pro-actively with PL and Team Members in order to

- identify issues that might change strategy and plan, delay timeline, and increase costs

- make recommendations to improve timeline and costs for project completion.

l When Business Development needs to technical advice for Business Development decision-making, A-PL is requested to give appropriate input in a prompt manner.

l A-PL should deal with other project-related tasks as necessary or as required.

Major Accountabilities

To be perfomed with advice/instructions from PL and or under supervision of PL (depending on his or her capability)

l Establish local development strategy/plan maximizing returns on portfolio management and build “one voice” development concept in global development strategy/plan, in collaboration with Global/Regional Project Management and Development Team Members.

l Drive local project activities efficiently with appropriate vendors through well-organized project management including time management, budget management, resource management, risk/issue management, quality management.

l Prepare or coordinate document packages submitted to Health Authorities (e.g. PMDA consultation package, CTN package, NDA package), vendors (e.g. request for proposal, contract), and other third parties.

l Establish sound relationship with KOLs and keep it.

l Control vendors efficiently (e.g. CRO, SMO, central lab, translation agency, printing works).

Ideal Background

l University degree in pharmaceuticals and/or bioscience

l Advanced degree in pharmaceuticals/bioscience preferred

l English both spoken and written

l Japanese as fluent

l Full and broader R&D experience and knowledge

l Significant (>5 years) experience in a R&D development function and R&D planning function in the pharmaceutical industry, especially in Respiratory therapeutic area..

l Demonstrated ability to think broadly and innovate within the pharmaceutical business, especially around product strategy and development plan and achievement

l Proven ability to work effectively across a matrixes and widely-dispersed organization

l Excellent interpersonal, communication, and influencing skills

l Demonstrated facilitation skills and success

l Excellent analytical ability

l Working knowledge of pharmaceutical R&D procedures and trends, and thorough understanding of product- relevant bioscience

l Must be experienced in MS Office and MS Project

l Must have knowledge of principles as in GCP guidelines and PAL

l Team oriented

l Age from 30 to 40’s

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