ประสบการณ์:

1 ปีขึ้นไป

ทักษะ:

Analytical Thinking, Quality Assurance, Risk Management, Data Analysis, Negotiation

ประเภทงาน:

งานประจำ

• Accountable for country delivery of Phase I-III clinical studies.
• Ensure timely study start-up, activation, enrollment, and close-out.
• Monitor country performance against operational KPIs.
• Drive recruitment acceleration initiatives and proactive risk mitigation.
• Escalate critical operational risks and ensure timely resolution. Site Strategy & Capability Development.
• Develop and execute Thailand's site strategy to support current and future oncology pipeline.
• Expand investigator relationships and strategic hospital partnerships.
• Strengthen feasibility quality and scientific site engagement.
• Drive innovative recruitment strategies, including patient referral networks and screening partnerships where appropriate.
• Support the expansion of Thailand's Phase I clinical trial capabilities. Cross-functional Leadership Provide strategic country leadership and foster effective collaboration across GCO and other functions to support successful clinical trial delivery and business objectives. Build strong partnerships and align priorities across: Clinical Operations Clinical Study Management Site Management Study Start-up Feasibility & Scientific Site Engagement Clinical Trial Management Associates (CTMA) Clinical Development Medical Affairs Regulatory Affairs Pharmacovigilance / Drug Safety Biometrics (Data Management, Biostatistics & Programming) Clinical Supply Chain Quality Assurance & Compliance Legal Contracts & Outsourcing Global Project Teams FSP partners and external vendors Commercial and Market Access (where appropriate) Government Affairs and Public Affairs (where appropriate) Represent Global Clinical Operations in country cross-functional governance forums and facilitate alignment between local, regional, and global stakeholders. Drive timely decision-making, issue resolution, and effective communication across all stakeholders to ensure successful study delivery and country performance. Build and maintain strong relationships with investigators, healthcare institutions, academic networks, collaborative groups, and other external stakeholders to strengthen BeOne's clinical research presence in Thailand. People Leadership.
• Lead, coach, and develop the Thailand Clinical Operations organization.
• Build a high-performing and collaborative team culture.
• Drive talent development, succession planning, and employee engagement. Foster a culture of accountability, innovation, and continuous improvement. Quality & Compliance.
• Ensure compliance with ICH-GCP, Thai FDA regulations, CREC requirements, and BeOne SOPs.
• Promote inspection readiness across all studies.
• Principal Investigators.
• Hospital leadership.
• Research institutions.
• FSP partners.
• Professional organizations.
• Regulatory authorities.
• Strengthen BeOne's reputation as a preferred clinical research partner in Thailand. Major.
• Accountable for Thailand Clinical Operations performance.
• Drive country operational strategy and execution.
• Deliver country enrollment and study execution targets.
• Develop country site expansion and investigator engagement strategies.
• Lead country governance meetings and portfolio reviews.
• Manage country operational risks and mitigation plans.
• Oversee resource planning and country operational capacity.
• Support implementation of new operational models and continuous improvement initiatives.
• Partner with regional and global functions to support BeOne's strategic objectives.
• Supervisory.
• Education.
• Required: Bachelor's degree or higher in Life Sciences or a related discipline (e.g., Medicine, Pharmacy, Nursing, Biology, or Medical Laboratory Science).
• Key Competencies.
• Strategic Leadership Country Leadership Clinical Operations Expertise Oncology Drug Development Site Network Development Investigator Engagement Cross-functional Leadership Operational Excellence People Leadership Stakeholder Management Quality & Compliance Risk Management Decision Making Change Leadership Business Acumen Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and other business applications.
• Working knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and other clinical trial technologies.
• Ability to utilize operational metrics, reporting tools, and clinical trial systems to support oversight, decision-making, and performance management.
• Minimum 12 years of experience in clinical research, clinical development, or the biopharmaceutical industry.
• Minimum 8 years of progressive leadership experience in Clinical Operations, including line management and country- or regional-level leadership responsibilities.
• Demonstrated experience managing Phase I-III oncology clinical trials.
• Proven experience leading country-level Clinical Operations within a global, matrix organization.
• Strong knowledge of ICH-GCP, Thai FDA regulations, and local clinical trial requirements.
• Demonstrated success in leading cross-functional teams and influencing stakeholders across multiple functions and organizational levels.
• Strong strategic thinking, business acumen, and sound decision-making skills.
• Excellent communication, negotiation, and stakeholder management skills, with the ability to build effective relationships with investigators, healthcare institutions, FSP partners, and internal stakeholders.
• Fluent in both Thai and English (written and spoken).
• Self-motivated, adaptable, and detail-oriented, with a strong sense of accountability and a proactive, can-do attitude.
• Travel.
• This role requires domestic and international travel.
• What We Offer.
• To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant!) In-house and external learning and development opportunities Fantastic benefits program and keep improving! Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we. Join us and Make momentum in your career! BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations. Due to BeOne's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne's Job Applicant Privacy Policy ( https://beonemedicines.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us.

ประสบการณ์:

1 ปีขึ้นไป

ทักษะ:

Analytical Thinking, Quality Assurance, Risk Management, Data Analysis, Negotiation

ประเภทงาน:

งานประจำ

• Accountable for country delivery of Phase I-III clinical studies.
• Ensure timely study start-up, activation, enrollment, and close-out.
• Monitor country performance against operational KPIs.
• Drive recruitment acceleration initiatives and proactive risk mitigation.
• Escalate critical operational risks and ensure timely resolution. Site Strategy & Capability Development.
• Develop and execute Thailand's site strategy to support current and future oncology pipeline.
• Expand investigator relationships and strategic hospital partnerships.
• Strengthen feasibility quality and scientific site engagement.
• Drive innovative recruitment strategies, including patient referral networks and screening partnerships where appropriate.
• Support the expansion of Thailand's Phase I clinical trial capabilities. Cross-functional Leadership Provide strategic country leadership and foster effective collaboration across GCO and other functions to support successful clinical trial delivery and business objectives. Build strong partnerships and align priorities across: Clinical Operations Clinical Study Management Site Management Study Start-up Feasibility & Scientific Site Engagement Clinical Trial Management Associates (CTMA) Clinical Development Medical Affairs Regulatory Affairs Pharmacovigilance / Drug Safety Biometrics (Data Management, Biostatistics & Programming) Clinical Supply Chain Quality Assurance & Compliance Legal Contracts & Outsourcing Global Project Teams FSP partners and external vendors Commercial and Market Access (where appropriate) Government Affairs and Public Affairs (where appropriate) Represent Global Clinical Operations in country cross-functional governance forums and facilitate alignment between local, regional, and global stakeholders. Drive timely decision-making, issue resolution, and effective communication across all stakeholders to ensure successful study delivery and country performance. Build and maintain strong relationships with investigators, healthcare institutions, academic networks, collaborative groups, and other external stakeholders to strengthen BeOne's clinical research presence in Thailand. People Leadership.
• Lead, coach, and develop the Thailand Clinical Operations organization.
• Build a high-performing and collaborative team culture.
• Drive talent development, succession planning, and employee engagement. Foster a culture of accountability, innovation, and continuous improvement. Quality & Compliance.
• Ensure compliance with ICH-GCP, Thai FDA regulations, CREC requirements, and BeOne SOPs.
• Promote inspection readiness across all studies.
• Principal Investigators.
• Hospital leadership.
• Research institutions.
• FSP partners.
• Professional organizations.
• Regulatory authorities.
• Strengthen BeOne's reputation as a preferred clinical research partner in Thailand. Major.
• Accountable for Thailand Clinical Operations performance.
• Drive country operational strategy and execution.
• Deliver country enrollment and study execution targets.
• Develop country site expansion and investigator engagement strategies.
• Lead country governance meetings and portfolio reviews.
• Manage country operational risks and mitigation plans.
• Oversee resource planning and country operational capacity.
• Support implementation of new operational models and continuous improvement initiatives.
• Partner with regional and global functions to support BeOne's strategic objectives.
• Supervisory.
• Education.
• Required: Bachelor's degree or higher in Life Sciences or a related discipline (e.g., Medicine, Pharmacy, Nursing, Biology, or Medical Laboratory Science).
• Key Competencies.
• Strategic Leadership Country Leadership Clinical Operations Expertise Oncology Drug Development Site Network Development Investigator Engagement Cross-functional Leadership Operational Excellence People Leadership Stakeholder Management Quality & Compliance Risk Management Decision Making Change Leadership Business Acumen Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and other business applications.
• Working knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and other clinical trial technologies.
• Ability to utilize operational metrics, reporting tools, and clinical trial systems to support oversight, decision-making, and performance management.
• Minimum 12 years of experience in clinical research, clinical development, or the biopharmaceutical industry.
• Minimum 8 years of progressive leadership experience in Clinical Operations, including line management and country- or regional-level leadership responsibilities.
• Demonstrated experience managing Phase I-III oncology clinical trials.
• Proven experience leading country-level Clinical Operations within a global, matrix organization.
• Strong knowledge of ICH-GCP, Thai FDA regulations, and local clinical trial requirements.
• Demonstrated success in leading cross-functional teams and influencing stakeholders across multiple functions and organizational levels.
• Strong strategic thinking, business acumen, and sound decision-making skills.
• Excellent communication, negotiation, and stakeholder management skills, with the ability to build effective relationships with investigators, healthcare institutions, FSP partners, and internal stakeholders.
• Fluent in both Thai and English (written and spoken).
• Self-motivated, adaptable, and detail-oriented, with a strong sense of accountability and a proactive, can-do attitude.
• Travel.
• This role requires domestic and international travel.
• What We Offer.
• To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant!) In-house and external learning and development opportunities Fantastic benefits program and keep improving! Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we. Join us and Make momentum in your career! BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations. Due to BeOne's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne's Job Applicant Privacy Policy ( https://beonemedicines.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us.

ประสบการณ์:

1 ปีขึ้นไป

ทักษะ:

Analytical Thinking, Quality Assurance, Risk Management, Data Analysis, Negotiation

ประเภทงาน:

งานประจำ

• Accountable for country delivery of Phase I-III clinical studies.
• Ensure timely study start-up, activation, enrollment, and close-out.
• Monitor country performance against operational KPIs.
• Drive recruitment acceleration initiatives and proactive risk mitigation.
• Escalate critical operational risks and ensure timely resolution. Site Strategy & Capability Development.
• Develop and execute Thailand's site strategy to support current and future oncology pipeline.
• Expand investigator relationships and strategic hospital partnerships.
• Strengthen feasibility quality and scientific site engagement.
• Drive innovative recruitment strategies, including patient referral networks and screening partnerships where appropriate.
• Support the expansion of Thailand's Phase I clinical trial capabilities. Cross-functional Leadership Provide strategic country leadership and foster effective collaboration across GCO and other functions to support successful clinical trial delivery and business objectives. Build strong partnerships and align priorities across: Clinical Operations Clinical Study Management Site Management Study Start-up Feasibility & Scientific Site Engagement Clinical Trial Management Associates (CTMA) Clinical Development Medical Affairs Regulatory Affairs Pharmacovigilance / Drug Safety Biometrics (Data Management, Biostatistics & Programming) Clinical Supply Chain Quality Assurance & Compliance Legal Contracts & Outsourcing Global Project Teams FSP partners and external vendors Commercial and Market Access (where appropriate) Government Affairs and Public Affairs (where appropriate) Represent Global Clinical Operations in country cross-functional governance forums and facilitate alignment between local, regional, and global stakeholders. Drive timely decision-making, issue resolution, and effective communication across all stakeholders to ensure successful study delivery and country performance. Build and maintain strong relationships with investigators, healthcare institutions, academic networks, collaborative groups, and other external stakeholders to strengthen BeOne's clinical research presence in Thailand. People Leadership.
• Lead, coach, and develop the Thailand Clinical Operations organization.
• Build a high-performing and collaborative team culture.
• Drive talent development, succession planning, and employee engagement. Foster a culture of accountability, innovation, and continuous improvement. Quality & Compliance.
• Ensure compliance with ICH-GCP, Thai FDA regulations, CREC requirements, and BeOne SOPs.
• Promote inspection readiness across all studies.
• Principal Investigators.
• Hospital leadership.
• Research institutions.
• FSP partners.
• Professional organizations.
• Regulatory authorities.
• Strengthen BeOne's reputation as a preferred clinical research partner in Thailand. Major.
• Accountable for Thailand Clinical Operations performance.
• Drive country operational strategy and execution.
• Deliver country enrollment and study execution targets.
• Develop country site expansion and investigator engagement strategies.
• Lead country governance meetings and portfolio reviews.
• Manage country operational risks and mitigation plans.
• Oversee resource planning and country operational capacity.
• Support implementation of new operational models and continuous improvement initiatives.
• Partner with regional and global functions to support BeOne's strategic objectives.
• Supervisory.
• Education.
• Required: Bachelor's degree or higher in Life Sciences or a related discipline (e.g., Medicine, Pharmacy, Nursing, Biology, or Medical Laboratory Science).
• Key Competencies.
• Strategic Leadership Country Leadership Clinical Operations Expertise Oncology Drug Development Site Network Development Investigator Engagement Cross-functional Leadership Operational Excellence People Leadership Stakeholder Management Quality & Compliance Risk Management Decision Making Change Leadership Business Acumen Computer Skills: Proficient in Microsoft Word, Excel, PowerPoint, Outlook, and other business applications.
• Working knowledge of Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) systems, and other clinical trial technologies.
• Ability to utilize operational metrics, reporting tools, and clinical trial systems to support oversight, decision-making, and performance management.
• Minimum 12 years of experience in clinical research, clinical development, or the biopharmaceutical industry.
• Minimum 8 years of progressive leadership experience in Clinical Operations, including line management and country- or regional-level leadership responsibilities.
• Demonstrated experience managing Phase I-III oncology clinical trials.
• Proven experience leading country-level Clinical Operations within a global, matrix organization.
• Strong knowledge of ICH-GCP, Thai FDA regulations, and local clinical trial requirements.
• Demonstrated success in leading cross-functional teams and influencing stakeholders across multiple functions and organizational levels.
• Strong strategic thinking, business acumen, and sound decision-making skills.
• Excellent communication, negotiation, and stakeholder management skills, with the ability to build effective relationships with investigators, healthcare institutions, FSP partners, and internal stakeholders.
• Fluent in both Thai and English (written and spoken).
• Self-motivated, adaptable, and detail-oriented, with a strong sense of accountability and a proactive, can-do attitude.
• Travel.
• This role requires domestic and international travel.
• What We Offer.
• To Our Valued Employees Market competitive compensation package including performance-based annual bonus scheme Company shares (generous welcome grant!) In-house and external learning and development opportunities Fantastic benefits program and keep improving! Plus you get to work with a dynamic team of collaborative, supportive, inclusive, and fun professionals whose mission is clear: Cancer has no borders and neither do we. Join us and Make momentum in your career! BeOne Global Competencies When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity BeOne is committed to respect and protect personal information rights of job applicants and will process job applicants' personal information in accordance with applicable laws and regulations. Due to BeOne's global operation, job applicants' data will be stored overseas with adequate protection. Besides, job applicants' data will be stored for no longer than is necessary to facilitate potential application for other suitable positions in BeOne. For further details, please refer to BeOne's Job Applicant Privacy Policy ( https://beonemedicines.com/privacy-policy ). If you voluntarily provide your personal information to us, it is deemed as you have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you voluntarily provide the personal information of other job applicants to us, it is deemed as you have ensured that the relevant individuals have acknowledged and consented to (if required by the applicable laws) BeOne's Job Applicant Privacy Policy as well as the relevant privacy terms. If you have any concern, please DO NOT provide any resume or other personal information to us.