Total 12 Director/C-Level clinical researcher job vacancies in Education / Training category in Malaysia

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the assigned indication(s).

• Serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy

• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions.

• Interpret and communicate clinical trial data.

• Author/review protocols, CSRs, publications, and regulatory submissions

• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL.

• Identify new clinical research opportunities.

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be required.

• This is a potential managerial role, successful prior experience seeking and developing talent is a plus.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.

• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.

• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.

• Involved in filing activities as part of the moving the program through the development lifecycle.

• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.

• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

ROLE SUMMARY

The purpose of the Senior Director of Clinical Research role is to coordinate and lead the development of first in man (FIH), proof of mechanism (POM), proof of clinical activity (SoCA) and proof of concept (PoC) and dose ranging studies for novel biological and small molecule therapies in Neurology focused programs. 

• The Senior Director of Clinical Research will be responsible for the Phase 2, PoM and SoCA trial designs and implementation of the study in collaboration with Pfizer development operations and the project team to meet enrollment and study delivery timelines.  The clinical study lead will be the primary liaison for investigators who have enrollment or extraordinary protocol issues that require escalation and may need to conduct study site visits to ensure timely delivery of the study.
• The individual will be involved with a focus on clinical drug activities from discovery research through PoM, SoCA and PoC studies. They will be a key member on project teams to collaborate with Early Clinical Development (ECD) and ensure seamless transition of the new asset to the Pfizer Global Product Development (GPD) for Ph3 development.

ROLE RESPONSIBILITIES

The Senior Director of Clinical Research will develop a disease specific global network of potential investigators and key opinion leaders (KoL) for the new therapeutic before PoM, SoCA or POC trial conception to assist in trial design, as well as management and recruitment of study, analysis, interpretation and presentation of results. Design PoM, SoCA or POC studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, etc.).

• Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile.
• Sit on project teams from FIH/POM/SOCA through POC trial completion to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g., start-up and delivery of PoM, SOCA and PoC trials.
   
• Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.
• Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.
• Expand the culture of collaboration between the clinical team and partners in the Inflammation and Immunology Research Unit (I&I RU) (Discovery, Pre-clinical and Systems Immunology), Clinical Pharmacology and Bioanalytics, Statistics, and Research and Developments (PRD) teams by maintaining open communications and ensuring successful program transitions. Foster a transparent environment that encourages strong trust between teams, sub-teams, and leaders.
   
• Sit on project teams from FIH/POM/SOCA through POC trial completion to ensure that clinical development strategies are in place, being implemented and are contributing to key development milestones, e.g., start-up and delivery of PoM, SOCA and PoC trials.
   
• Accountable for safety across the study, including regular review of safety data (including but not limited to serious adverse events) and response to safety issues.

• Provide leadership to the clinical function in preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents. Expand the culture of collaboration between the clinical team and partners in the I&I RU and PRD by maintaining open communications between the two groups and ensuring successful program transitions.

• Foster a transparent environment that encourages strong partnerships and mutual trust between teams, sub-teams, and leaders.
   

• Coordinate with other clinical research activities in the I&I RU and greater PRD organization.

• Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.
   

Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.
Develop effective collaborations with key PRD partners in design of POC studies and develop target clinical goals to benchmark success of POC and SoCA studies. 

Work on transition team with Late-stage development colleagues to analyze and interpret final POC clinical data in achieving study objectives and develop the phase 3 clinical strategy to support seamless transfer of the asset to the respective Phase3 team.

Establish relationships with external experts, consultants, opinion leaders, regulators and disease specific investigator networks.

The applicant will have the opportunity to participate in strategic assessment of I&I RU portfolio, and Business Development activities.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

QUALIFICATIONS

Education: Requires MD or MD/PhD, neurology specialty required, but other specialists with experience in neurology clinical trials will be considered.

Technical Skills: Experience in generating hypothesis-driven research investigations.

Five or more years of experience in biopharmaceutical sponsored clinical research, with a minimum of two in neurology. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable.

Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches.

Ability to analyze and interpret complex datasets.

Ability to operate with a sense of pace and urgency in matrixed project teams.

Exercises initiative in meeting goals and drives innovation in projects.
 

Demonstrated scientific productivity (publications, abstracts, etc.).

Good communication and presentation skills as well as proven scientific writing skills.

This role is relocation eligible.

Relocation assistance may be available based on business needs and/or eligibility.

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director, Inflammation

Live

What you will do

Let’s do this. Let’s change the world. The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is US - Remote.

Responsibilities:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions

• Interpret and communicate clinical trial data

• Author/review CSRs, publications and regulatory submissions

  Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

• Identify new clinical research opportunities

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be require

• Potential managerial role, seeking and developing talent in past will be a plus

Knowledge:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development esp Ph2/3 registrational trials

• Medical knowledge in the relevant therapeutic area

• Sound scientific and clinical judgment

• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Prior experience of regulatory interactions, authoring filing IND or BLA experience

• Understanding of new drug commercialization and business practices

• Understanding of resourcing and budgeting

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development lifecycle.
• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $256,334. - $318,868.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

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

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):

Career Category

Job Description

Salary Range

You will support the Deputy Chief Executive Officer, Research & Education to oversee and implement the research programmes and initiatives of the National Dental Research Institute Singapore (NDRIS). Additionally, you will support the Academic Chair to oversee the academic initiatives under the Oral Health Academic Clinical Program (ORH ACP). You will be in-charge of managing research and academic support grants awarded to NDRIS and ORH ACP.

You will be responsible for research and academic strategic planning and implementation of the NDRIS’ and ORH ACP’s research and academic masterplans. You will be in charge of formulating and reviewing research and academic policies and procedures. You will be required to develop grant proposals and presentation decks for research and academic programmes and prepare cases for support to attract philanthropy funding. You will oversee the organisation of strategic initiatives, including planning strategic retreats, study trips and visits by key overseas delegations. You will facilitate partnerships with collaborators and industry players.

Requirements:

• PhD/ Masters in Science or other related field with minimum 10 years of relevant experience in research and academic administration
• At least 6 years of supervisory experience will be preferred
• Able to work independently and lead a team and function well in a team-based setting
• Possess good leadership, interpersonal, communication, organizational, time-management, analytical, presentation deck development and writing skills
• Highly motivated with strong ability to drive initiatives