Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• 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.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, 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.
• 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.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• 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).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Under the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to: data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with Standard Operating Procedures. Works with management to maintain the consistent execution of quality global procedures and monitors workload and resource allocation. Supports the comprehensive development of junior supervised staff and encourages effective interaction of Data Management Center staff with business partners to achieve common objectives. Is accountable for the quality and timely execution and delivery of Global Data Operations deliverables at the trial level.

Education:

At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge and Skills:

Four years’ experience in data management, medical research, or database design and development is preferable. Extensive start-up and in-life data management experience is required. Knowledge of database structures and available tools to manage, extract, and report data is preferred. Fluent Oral and written English language skills. Knowledge of applicable regulations and policies. Proficient overall working knowledge of the clinical development process.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

It is critical that, for all our company-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The position has a significant impact in achieving those objectives.Under the guidance of the Regional Director, Clinical Quality Management Leads, the role oversees all CQM activities in the respective country/cluster and responsible to manage a team of CCQMs.

The role is reponsible for Quality Strategy and Training Strategy development for GCTO China, and requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives.

Qualifications:
• Bachelor's Degree or equivalent in relevant health care area.

Experience:
• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred.
• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Demonstrated experience in leading cross-functional teams.
• Ideally, experience in Clinical Quality Management including Quality Control Activities,Process Management & Improvement.
• Ideally, experience in managing audits and inspections.
• Ideally, experience in coordinating and delivering training sessions.

Skills:
• Superior oral and written communication and leadership skills in an international environment.
• Excellent project management, organizational and prioritization skills.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• 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.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, 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.
• 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.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• 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).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Brief Description of Position

Position Overview:

Under the direction of the applicable management, the Senior Clinical Data Manager (SCDM) is responsible for executing end to end data management activities pertaining to clinical trials, including but not limited to; data management tool and system development, validation and maintenance, data collection, data integrity review and reconciliation, query management, medical coding, and database lock preparation, in compliance with company Standard Operating Procedures (SOPs) and ICH-GCP guidelines.

Primary activities include, but are not limited to:

• All responsibilities of a Clinical Data Manager.
• Assume data management responsibilities for larger, more complex or higher priority protocols.
• May coordinate general ad-hoc Sponsor Data Entry (SDE) process for the protocol, discuss timelines, and provide data entry status to the Clinical Development Scientist (CDS).
• Provide protocol specific training of SDE Process to CDM.
• Triage, research, discuss and resolve the reports outputs provided by Clinical Development Scientist (CDS) and Statisticians at a protocol level during in-life and database lock stages supported by the LCDM. Execute special reports in different systems and coordinate the resolution under direction of the LCDM.
• Responsible for the preparation, creation, validation and review of data management tool specifications and tools under the direction of the LCDM, including but not limited to: eCRFs, Time & Events Schedules, eCRF Entry Guidelines, Edit Checks, Data Review Plans (DRPs) and In-life Reports, Encoding and Data Management Plans (DMPs).
• Coordinate User Acceptance Testing (UAT) of the Clinical Database Repository under the direction of the LCDM.
• Coordinates communications, global status tracking and issue resolution at study level with Lead CDM (LCDM).
• Support LCDM in interaction and communication with customers and stakeholders both internal and external to GDMS as well as company when needed.
• Responsible for the communication with Clinical Trial Operations team regarding site level issues on a protocol on behalf of the LCDM.
• Monitor protocol level cycle time performance (metrics) and follow up on specific countries/sites metrics issues and deliver status and resolution updates to LCDM.
• Responsible for study level status assessment, reporting and communication with LCDM.
• Coordinate and mentor CDMs and other SCDMs who work in his/ her protocol to maintain compliance with SOPs, data management plans and data review plans.

• Be assigned to special responsibilities related to process maintenance, data quality assessment, staff training and mentoring and/ or other special activities, such as providing inputs to create or update SOPs, supporting documents and training materials as needed.
• May contribute to special activities such as   supporting DMC Process Owner (PO) Models in the local DMC and/or in the Global PO networks.
• Participate in cross functional technical or process improvement projects.

Qualifications, Skills & Experience

Education:

At least B.A. or B.S. degree, preferably in Medicine, Pharmacy, Nursing, Biological Sciences, or health care related discipline.

Knowledge and Skills:

1. Two years’ experience in clinical data management in pharmaceutical or health care clinical research environment is preferable.

2. Self-motivated, excellent in work planning and time management.

3. Fluent oral and written English skills.

4. Good basic awareness of the clinical development process.

5. Good basic awareness of clinical practice and grasp of medical terminology.

6. Good sense and awareness of regulations and policies.

7. Able to work under pressure and in a changing environment with flexibility.

8. Good communication skills with the ability to communicate with both technical and business areas.

9. Proven leadership skills, specifically the ability to coordinate the work of others and influence management on decision making.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Position Overview

China Development Center seeks individuals to provide leadership and experience in conducting clinical research in China. One of the most important mission of clinical research in China is to shorten gap of the drug lag in China so effective treatment options become available to Chinese patients. This individual will be the key driver of assigned program(s) for developing local registration strategy, engaging key opinion leaders, developing study protocol, drafting study report, and preparing dossier for regulatory submission.

Main Responsibility

• 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 supporting China registration.  
• 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.
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs 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. 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.

Requirements

• Master or above degree in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable,
• Be bright, driven, dedicated, persistent, strategic, flexible, clever, and resourceful. 
• 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.   

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Responsibilities:

• Provide professional and efficient administrative support to senior leader of the company's China R&D, Including Calendar management, Trip (meeting) arrangement, Reimbursement, Effectively coordinate with function directors and all admin related work.
• Organize regular Management Meetings, Headquarter Leader visit and support site level events, such us Family Day and Annual Meetings etc. Control the budget and cost in a reasonable and effective way.
• Company culture build-up, actively involved in design and implement social committee activities as well as Corporate Society Responsibility activities. and dedicate in R&D newsletter design and publish work with innovative ideas.

Requirements:

• Bachelor Degree: English or Administrative Management major with oversea education background is preferred.
• Minimum of 5 years secretary experience in multi-national companies.  
• Excellent command of spoken and written English is essential.
• Proficient in MS-office applications, such as Word, Excel, PowerPoint, etc.
• Possesses good organizational and communication skills.       
• Initiative and have high integrity and confidentiality in handling jobs.
• Good understanding of Company's working procedures and Compliance.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Department:

 Quality Assurance (QA)

Reports to:

Head of Therapeutic Area Quality

Function:

Senior Director,  QA Head, Asia-Pacific (AP)

Position Overview: Basic Functions & Responsibilities

Essential functions include but are not limited to:  working independently, with limited guidance to ensure implementation and management of the Quality Assurance strategy for Asia-Pacific (AP) across Therapeutic Areas (TA) for multiple programs and indications. The  QA Head, Asia-Pacific (AP) will ensure quality principles are considered throughout the drug development process, risk mitigation strategies for programs underway are implemented and quality metrics, including audits, are utilized to inform the business of the state of quality of the programs within their respective therapeutic area. The  QA Head, Asia-Pacific (AP) will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants.   This role will be responsible to perform risk assessments for the region to identify audit targets, conduct audits, develop and maintain audit tools, as well as, review audit reports.  They will work to assure quality standards are consistently applied and will escalate resource and data quality matters to Senior Management as appropriate. This role will also enable cross functional regional and local QA activities with respect to vendor, laboratory qualification and support activities, as well as business partner functions in Pharmacovigilance and Medical Affairs. In addition, this role will be key in ensuring excellence in communication between the China R&D and Quality Leadership teams.

Primary Activities:

Primary activities include but are not limited to:

Provides QA strategic guidance to both internal and external stakeholders in the AP region. Responsible for practical knowledge of current and emerging global guidelines and regulations in the region, relevant regulatory approaches and actions and status of competitor/similar products/projects to effectively develop and advance QA strategies. Maintains robust audit and quality assurance oversight plans for local and regional activities in support of clinical trials, contributes to the QA strategy and through collaboration with stakeholders,  QA Clinical Head and  QA TA Heads, refines and adjusts strategies and plans as needed. Building strong relationships with all LT functions across  QA organization. Identifies areas of greatest risk, through intelligence gathering (e.g., data trends, identified quality issues, regulatory intelligence), to proactively and accurately address and complete risk- based QA assessments and influence the implementation of robust mitigation strategies. Lead and manage a range of GCP and/or Good Pharmacovigilance Practice (GPVP) audits, local/regional vendor audits, including complex audits (i.e., directed, for-cause), for a given program and/or across programs for the region.  Interfaces with relevant stakeholders, including regulatory, clinical and development, as appropriate, to provide Good Clinical Practice, Pharmacovigilance QA expertise. Support the Significant Quality Issue management process related to issues related to AP region, including assessment of potential root causes and remediation (corrective and preventative actions). Develops and enhances QA procedures, guidance documents and audit tools to ensure consistent global QA practices. Ensures rapid communication of QA issues including potential misconduct or issues of significant deviation within project/products to appropriate leaders and colleagues. Provides inspection management support as needed. Manage personnel or assist with the management of personnel and planning functional group activities to achieve functional area and/or departmental objectives, as applicable. Provides guidance and collaborates with QA Specialists, as appropriate, to assure adequate audit focus and timely knowledge transfer. Provides training, mentorship and development opportunities to  QA AP staff.

Skills:

Primary skills include but are not limited to:

Collaboration and Partnering:  Demonstrates advanced ability to work in partnership with others (within  QA and external to  QA) to accomplish quality goals; possesses advanced leadership skills.

Communication Skills:  Demonstrates expert communication skills to convey and receive information.  Demonstrates advanced oral and written communication skills. 

Problem Solving:  Demonstrates advanced skills in problem solving using creative thinking, gathers data from appropriate stakeholders and responds to new, complex or problematic situations to influence organization direction. 

Strategic Thinking:  Demonstrates advanced skills to drive change that enhances processes within  QA or across areas within  to improve quality and /or add value to the business.  

Project Management:  Demonstrates advanced ability to organize work efforts, prioritization of tasks and utilize appropriate resources to deliver or support work products in accordance with timelines and appropriate regulations. 

Decision Making:  Demonstrates advanced skills to utilize knowledge, networks and data to make rapid and appropriate decisions and to determine when escalation of issues is necessary.

Business Operations/Knowledge of Field: Demonstrates advanced level of knowledge of regulations and business trends and applies this knowledge to optimize daily activities and make appropriate decisions that improves the quality of business and functional area outputs. Regulatory and Compliance Management: Demonstrates advanced knowledge of regulations and regulatory trends to ensure  QA and appropriate functional areas within  are compliant with regulations and appropriate procedures and policies and proactively manages and mitigates risks to achieve quality outcomes.

Education/Experience:  BS/BA degree in relevant area with extensive experience in field and knowledge of therapeutic area.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

The China Clinical Research Vaccine Head is a leadership role responsible for providing strategic direction and oversight to the clinical research activities within Vaccine Therapeutic Area. This position plays a critical role in driving the development and execution of clinical research programs to support the company's drug development objectives.

Job Responsibilities:

Strategic Leadership: Providing exceptional scientific and medical leadership in clinical research Vaccine Therapeutic Area, aligning with the overall corporate goals and objectives, contributing to groundbreaking advancements in the field of Vaccine.

Clinical Development Strategy: Develop and implement the clinical development strategy for the Vaccine TA, ensuring alignment with regulatory requirements, patient needs, and market demands.

Clinical Program Management: Oversee the planning, execution, and management of global clinical research programs, including study design, protocol development, site selection, data collection, and analysis.

Team Management: Provide leadership, guidance, and mentorship to a team of clinical research professionals, ensuring their professional development and success.

Collaboration and Stakeholder Engagement: Collaborate with global and China cross-functional teams, including medical affairs, regulatory affairs, biostatistics, and commercial departments, to ensure seamless integration of clinical research activities.

External Partnerships: Establish and maintain collaborative relationships with key opinion leaders (KOLs), investigators, academic institutions, and other external stakeholders to enhance clinical research opportunities and scientific insights.

Risk Management and Compliance: Ensure compliance with regulatory guidelines, data integrity, ethical standards, and company policies throughout the clinical research process.

Budget and Resource Management: Manage the clinical research Vaccine team budget and resources effectively, optimizing resource allocation and ensuring efficient utilization.

Education:

• Advanced degree in a relevant scientific discipline (e.g., MD, PhD)
• In-depth understanding of the drug development process, including clinical study design, data analysis, and regulatory requirements.
• At least 10 years of experience in clinical research, with a track record of developing China development strategies, protocols, successful execution of strategies, and registration of drugs in China. (Vaccine TA experience not mandatory)
• Strong leadership skills. Proven leadership in promoting, motivating, and empowering others to accomplish individual, team, and organizational objectives are desirable.
• Excellent communication skills.in both English and Chinese, with fluency in verbal and written communication.

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Main Responsibility

• The clinical research physician is expected to abstract high level relevant clinical and preclinical data and effectively use these data in supporting China registration.  The clinical research physician is expected to address issues/questions raised.
• 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.  
• The clinical research physician will also work as clinical scientist, to lead lab selection and clinical supply application during study planning phase, provide scientific inputs, 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.
• 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.

Requirements

• Master Degree and above in clinical medicine (at least 5 year medical school graduates)
• Deep understanding of China regulatory environment and clinical development procedure.
• Previous experience of clinical research/clinical development is highly desirable.
• 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).

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

• Position Objective

  We are looking for a highly motivated individual with expertise in scientific andand business strategic planning to join our team at China R&D. The primary objective will be to gather information from internal and external sources toformulate business review materials and summarizee scientific and operational results for scientific breakthrough monitoring, technology briefing book, external pipeline analysis, generate insights, and suggest actions. The ideal candidate should also possess the potential to manage projects effectively and have a strong understanding and familiarity with innovation in the United States.

  Duties and Responsibilities

• head of strategic planning  Coordinate with cross-functional teams to gather relevant data and insights, ensuring accuracy and consistency in communication materials. Continuously improve communication processes and materials, leveraging feedback and data analytics to optimize effectiveness and impact.
• Assist in crafting clear and compelling messaging to effectively communicate complex scientific and business concepts to diverse audiences. Prepare high-quality, engaging presentations for internal and external stakeholders, showcasing key insights, strategic initiatives, and progress updates.
• Collect and summarize relevant publications on scientific, technological, and pipeline advancements, employing data analysis and research skills to extract essential information, formulate briefing drafts of assets analysis, recommend actions.
• Stay informed about industry trends, regulatory developments, and market dynamics to support critical decision-making and effectively tailor strategic communication messages and presentations.
• Plan, coordinate, and manage projects from initiation through completion, ensuring delivery within specified timelines and budgets.
• Fulfill other duties assigned by the supervisor in alignment with the strategic planning role.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

• Education and Experience:

• Master's degree or above in life or biomedical sciences or a related field. Strong understanding of scientific principles and the pharmaceutical industry.
• Proven track record of successfully managing projects, demonstrating strong organizational and leadership skills.
• Familiarity with the innovation landscape in the United States, including knowledge of emerging trends, drug discovery process and technologies.

• Communication and Presentation Skills:

• Excellent written and verbal communication skills in Chinese and English.
• Ability to create compelling and concise presentations.
• Experience in conducting landscapelandscape research and competitive analysis.
• Ability to gather insights and identify opportunities and risks.
• Understanding of the Nasdaq stock exchange, its operations, and its impact on the business environment.

• Collaboration and Analytical Skills:

• Strong interpersonal skills and ability to work effectively with cross-functional teams.
• Critical thinking, analytical mindset with attention to detail in gathering and interpreting data accurately.

• Landscape Research and Analysis:

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

Job Summary: As the Director/Senior Director, you will play a pivotal role in closely collaborating with our HQ oncology asset team, shaping the overall asset China strategy, and enabling seamless coordination across different tumor types and Clinical Project Development Teams (CPDTs). In addition to your strategic responsibilities, this role also involves team management, where you will provide leadership, guidance, and mentorship to a team of clinical research professionals, fostering their professional development and ensuring their success.

Job Responsibilities:

• Providing exceptional scientific and medical leadership for developing China overall strategy for responsible new assets
• Managing selected opportunities and developing comprehensive strategies that encompass realistic milestones, performance measures, timelines, and budgets to achieve designated value inflection points in our asset portfolio.
• Developing innovative clinical development strategies for investigational or marketed oncology drugs, harnessing cutting-edge science to revolutionize treatment outcomes and patient care.
• Crafting meticulous plans for clinical trials, including detailed design, operational plans, and settings that align with our clinical development strategies, ensuring scientific rigor and regulatory compliance.
• Monitoring and overseeing ongoing or new clinical trials for investigational or marketed oncology drugs, ensuring their successful execution, data integrity, and adherence to protocols.
• Analyzing and summarizing the clinical findings from studies, providing critical insights to support decisions on safety, efficacy, new drug applications, clinical study reports, and publications, shaping the future of oncology therapies.
• Providing leadership, guidance, and mentorship to a team of clinical research professionals, fostering their professional development, empowering their growth, and enabling their success.

Current Employees apply HERE

Current Contingent Workers apply HERE

Secondary Language(s) Job Description:

Requirements:

To excel in this role, you should possess the following qualifications:

• M.D. or M.D./Ph.D. degree, showcasing your exceptional medical and scientific credentials.
• Deep knowledge and broad experience (likely ≥5 years) in drug  clinical development from early to late stage, including significant cross-functional project team experience.
• Strong awareness of the Oncology therapeutic area, encompassing current and emerging treatment pathways in major tumor types, enabling you to drive transformative solutions.
• Demonstrated leadership and decision-making skills in a cross-functional project team environment, guiding teams towards successful outcomes.
• Solid understanding of the commercial, regulatory, and broader strategic aspects of drug development, with a keen awareness of the competitive landscape, facilitating informed decision-making.
• Proven experience in building external networks and fostering effective relationships with external experts, enhancing collaboration and driving collective success.

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Description

This role is primarily accountable for the end-to-end performance and project management forassigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Provide 
a key support role to TA-Head / CRD to effectively manage team, volume of clinical trials, and local/regional or global projects. The Sr. CRM (Senior Clinical Research Manager) may be responsible for managing a specific study for several countries within a cluster.

Responsibilities include, but are not limited to:
• Main Point of Contact (POC) for assigned protocols and link between Country Operations and Clinical Trial Team (CTT).
• May support TA-Head / CRD with oversight of Therapeutic Area program(s) and strategy alignment as needed.
• Responsible for project management of the assigned studies: pro-actively plans, drives andtracks execution and performance of deliverables/timelines/results to meet country commitments from
feasibility and site selection, recruitment, execution and close out.
• Accountable for performance for assigned protocols in a country in compliance with ICH/GCP and country regulations, company policies and procedures, quality standards andadverse event reporting requirements internally and externally.
o Reviews Monitoring Visits Reports and escalates performance issues and trainingneeds to CRA-Manager and/or functional vendor and internal management as needed.
o Performs Quality control visits as required.
• Leads local study teams to high performance: trains in the protocol other local roles, closely collaborates with and supports CRAs as protocol expert and coordinates activities across the different local country roles ensuring a strong collaboration (including the CTCs, CRAs and COMs).
• Responsible for creating and executing a local risk management plan for assigned studies.
• Ensures compliance with CTMS, eTMF and other key systems in assigned studies.
• Escalates as needed different challenges and issues to TA-Head/CRD/CCQM and or CTT(as appropriate).
• Identifies and shares best practices across clinical trials, countries, clusters.
• May act as a mentor. 
• Responsible for collaboration with functional outsourcing vendors, investigators, otherexternal partners in assigned studies.
• Country POC for programmatically outsourced trials for assigned protocols.
• As a customer-facing role, this position will build business relationships and represent our company with investigators and medical centers.
• Serves local business needs as applicable in his/her country (if delegated can sign contracts and manage budgets).
• Supports local and regional strategy development consistent with long‐term corporate needs in conjunction with CRD, TA-Head and Regional Operations.
• Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilance, Global Medical Affairs to align on key issues/decisions across the trials. Consult with Global Human Health BU as needed.

Qualifications, Skills & Experience

Skills:
• Expertise in project and site management. The position requires demonstrated successful implementation of project management skills at program and site level. 
• Strong organizational skills with demonstrated success required.
• Requires ability to make decisions independently and oversee important activities relevant to clinical research activities according to predetermined global policies andcommitments.
• Requires a complete understanding of ICH GCP and global/regional/local regulatory environment.
• Strong scientific and clinical research knowledge is required. Including extensive knowledge of regional and/or country clinical trial landscape. 
• Deep understanding of the organizational structure of our R&D Department and cross-functional roles and responsibilities of its members. 
• Strong understanding of clinical trial planning, management and metrics is essential aswell as the ability to focus on multiple deliverables and execute complex protocols simultaneously.
• Experience functioning as a key link between Country Operations and Clinical Trial Teams.
• Communicates effectively and fosters a collaborative spirit in a remote/virtual environmentand across countries, cultures and functions.
• Ability, experience, and skills to proactively manage resource allocation, processes (and controls), productivity,quality and project and/or program delivery.
• Oversee TA strategy alignment and consolidate relevant information, within specific indications, escalating to the TA-H / CRD accordingly. 
• Proficiency in written and spoken English and local language. The incumbent must be competent and effective in written and verbal communication.
• Strategic thinking.
• Ability to work efficiently in a remote and virtual environment.
• The position requires proven strong project management skills and/or project management certification or relevant training program/close mentoring.
• High emotional intelligence
• Ability to focus on multiple deliverables and protocols/projects simultaneously.
• Exercise strategic thinking and executes effectively across projects
• Fosters understanding of cultural diversity.
• Strong leadership skills that enable and drive alignment with the goals, purpose and mission of our R&D Department, Global Clinical Development and Global Clinical Trial Operations.
• Ability to identify problems, conflicts and opportunities early and lead, analyze and creatively prepare mitigation plans and drive conflict resolution is critical.
• Required to negotiate skillfully in tough situations with both internal and external groups; settle differences with minimum disruption. Examples of common problems include:

1) low patient recruitment,

2) inadequate staff to meet business needs,

3) performance or compliance issues,
4) working with regulatory issues and the broader organization, and
5) resolution of conflictive situations.
• Educational/pedagogic, diplomatic and empathic skills to effectively build and maintain professional relationships with investigators and other stakeholders.

Qualification & Experience:
Required:
• 10+ years of experience in clinical research with demonstrated success 
and increasing responsibilities of which 5+ years consisted of leading projects
• Bachelor degree in Science (or comparable)

Preferred:
• CRA Experience preferred
• Advanced degree, (e.g., Master degree, MD, PhD)

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):