Assoc. Dir, Clinical Research

Job Description

Associate Director Clinical Research Early Phase

Location: Beijing& Shanghai

Report to: CR group 1 lead

Our Company seeks individuals to provide leadership and experience in conducting early clinical research in China. One of the most important missions of clinical research in China is to conduct innovative clinical research thus broaden the indications and facilitate the drug development globally. This individual will be the key driver of assigned program(s) for developing products towards registration with efforts on developing study protocol engaging key opinion leaders drafting study report and preparing dossier for regulatory submission.

As Clinical Lead in Early China Product Development Team clinical research physician will play a key leadership role for the clinical development in China. This individual will be responsible and accountable for the development of best China development plan. Clinical research partners closely with headquarter project development team China regulatory affair project management clinical trial operation team for flawless plan and execution of early clinical studies in support of eventual registration. This individual is expected to be responsible for different programs across therapeutic franchise.

• This individual will serve as the key interface between headquarter project development team and China development center. The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in support of study design. The clinical research physician will represent clinical development team of China development center on headquarters project team as needed and this individual is expected to address issues/questions raised by headquarters team and provides feedback to headquarters project team from China perspective. This individual should have excellent communication skill with demonstrated language skills in both written and verbal English and Chinese.

• Whenever Clinical Research designs a clinical study the clinical research physician (clinical monitor) is expected to drive study design and collaborate with biostatisticians regulatory affairs and other relevant disciplines to construct a high-quality clinical study protocol. We place high value on efficient feasibility most desirable labels and cost effective necessitating careful collaboration with operational experts such as colleagues from global clinical trial operation. The clinical monitor will interpret prepare clinical study reports regulatory dossier regulatory responses and review product label. The clinical research physician will also prepare and review manuscript for this role this individual will work with study team to ensure safety/efficacy information adequately captured and review serious adverse events. Clinical research physician will review and approve monitoring plan/reports/data listings.

• The clinical research physician will also work as clinical scientist to lead lab selection and clinical supply application during study planning phase and investigator meeting during study initiation phase and review protocol deviation and answer protocol related questions during study implementation phase.

• To develop the best most suitable clinical plan and protocol the clinical research physician is expected to engage scientific leaders and internal key stakeholders such as medical affair and marketing and regulatory affair etc. The clinical physician will be involving in introducing new compounds in development to China scientific leaders and seek feedback for our clinical development plan as needed.

• The clinical research physician will participate due diligence evaluation as expert for medical related matter. Clinical physician is also working closely with medical affair to identify gap/opportunities of patient care in China and develop clinical plan/study to capitalize the emerging opportunities.

任职资格

Requirement:

• A PHD/Master in clinical medicine with postgraduate training in oncology or relative major.
• Deep understanding of China regulatory environment and clinical development procedure.
• More than 5 years clinical research/drug development working experience. Previous experience of early clinical research/clinical development (ph1 trials) is highly desirable including strategy development medical monitoring and protocol/ writing.
• The candidate who is ideally suited for this position will be bright driven dedicated persistent strategic flexible clever and resourceful.
• The candidate should have a strong leadership excellent written and oral communication skills and project management skills.
• Strong capability of work prioritization and deliver results with parallel multiple tasks.
• Excellent language skills in both English and Chinese (fluent in verbal and written).
• The position may require the flexibility to work outside of the area of primary medical specialization.

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Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.

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