Johnson & Johnson Careers

Clinical Program Leader

Beijing, China; Kuala Lumpur, Malaysia; Singapore, Singapore
Clinical Trial Coordination


Job Description

Requisition ID: 1905763800W

1.     POSITION TITLE:  MAO Clinical Program Leader (CPL) – Managed Access (MAc) (PG 40)

2.   POSITION SUMMARY: Briefly state the objective of this position.

The MAO CPL is accountable for the successful planning, execution and reporting of a portfolio of assigned local, regional and/or global MAc programs (including Post Approval access, Post Trial access and Pre-Approval Access initiatives such as Named Patient Programs (NPPs) and single patients requests (SPRs)), across all TAs. This includes adequate resource planning and allocation, meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements. 

 

The MAO CPL-MAc acts as the single point of end-to-end accountability within GCDO-MAO at the overall portfolio/program level and has strong leadership accountability to lead high performing teams.  The position serves as the key contact for and managing relationships with global, regional and local Business Partners (e.g. Medical Affairs and R&D), other internal Business Partners (eg. CF&A and FP), and external suppliers.

 

The MAO CPL-MAc is responsible for coordinating all activities within R&D Operations (RDO) and other key subject matter experts [e.g. Global Medical Safety (GMS)].

 

The MAO CPL-MAc leads and supervises a team of Associate Director Global Trial Managers (AD GTMs), Global Trial Managers (GTMs), Trial Managers (TMs) and Global Trial Manager Clinical Trial Assistants (GTM-CTA) and ensures consistencies across MAcs and leverages synergies and innovative approaches across portfolio/programs.

 

This MAO CPL-MAc is accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering  a diverse work force that works seamlessly in a highly matrixed environment.

PRINCIPAL RESPONSIBILITIES: 

·       Is the single point of accountability for the overall MAc program portfolio. Provides strategic operational expertise and leadership to    ensure operational delivery of MAc programs with regards to time, quality and budget.

 

Oversees the budget forecasting and management inclusive of OOP and FTE estimates. Partners with the AD GTMs for project related milestones and adequate resources. Ensures effective resource availability and assignments for MAc programs.

 

Oversees the Request for Service (RFS) process and partnerships with Clinical Forecasting & Analytics (CF&A) and other functions if appropriate (e.g. Pharmaceutical Development & Manufacturing Sciences).

 

Ensures  operational consistency across all MAc programs within the portfolio/program, working with the Global Operations Lead and regions.

 

Promotes optimal communication between the AD-GTMs/GTMs/TMs/GTM-CTAs and GCDO functions, if appropriate, internal Business Partners, and other key subject matter experts experts [e.g. Global Medical Safety (GMS)]). Ensures timely provision of status updates on project deliverables to the Business Partners and/or other enterprise sectors, as applicable.

 

Provides leadership to plan and/or define risk mitigation strategies and ensures implementation.

 

Communicates regularly with the Global Operations Lead (GOL) on all issues and risks related to project resources, timelines and budget. Makes recommendations for solutions and aligns with the GOL, as appropriate, on the action plan. Work with relevant project stakeholders/management teams to implement solutions/action plans.

 

Ensures project objectives are met according to all applicable regulations, legislations, guidelines and internal SOPs/policies.

 

Accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering  a diverse work force that works seamlessly in a highly matrixed environment.

 

As applicable, acquire and sustain advanced knowledge of  appropriate therapeutic area(s), product and project setting.

 

Establishes strong relationships with COHs, other CPLs and GOLs within GCDO across all regions and therapeutic areas.

 

Provides recommendations to functional manager on functional and project execution strategies, and people management-related topics. Is pro-active in defining continuous improvement initiatiatives that help further shape the organization, and take a lead role in the execution and deliver of some of these initiatives.

 

Contributes to the design, development, and evaluation of  operational processes and standards.

 

4.  RESPONSIBILITY FOR OTHERS(If applicable): Describe the nature of supervision exercised over others by this position.

 

The MAO CPL reports to the Global Operations Lead, Managed Access.

 

The MAO CPL is responsible for a team of Associate Director Global Trial Managers (AD GTMs), Global Trial Managers (GTMs), Trial Managers(TMS) and Global Trial Managers-Clinical Trial Assistants(GTM-CTAs).

 

ADDITIONAL RESPONSIBILITIES:

·       Provides timely and accurate updates and ensure transparency to GCDO Management and internal business partners on the delivery status of portfolio/program and contributes to Governance bodies as applicable

·       Leads and/or supports  GCDO and other cross-functional or cross-sector initiatives, as assigned and identification of innovation opportunities.

·       Responsible for interviewing and hiring of GCDO-MAO AD GTMs, GTMs, TMs, GTM-CTAs, as appropriate..

 

EMPLOYEES SUPERVISED: CHECK ALL RELEVANT

 

EXEMPT:               

NON-EXEMPT:     

PART-TIME:           

 

TEMPORARY:      

CO-OP:                   

CONSULTANT:     

 

 

5. WORKING RELATIONSHIPS/INTERFACE: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. Describe the primary working relationships (internal & external) and primary interfaces.

·       Internal contacts: COHs, other CPLs, GTMs, TMs and GTM-CTAs, Global Medical Affairs Leads, Regional and Country Medical Affairs teams, Therapeutic Area (eg. Compound Development Leads, Study Responsible Physicians/Scientists), Patient support,  RDO COEs FP, PDMS, Finance , Legal,  Procurement (JRP), Quality Management & Training group; HCBI/HCC, and other J&J enterprise sectors, as applicable.

 

·       External contacts: external service providers and other partners

 

6. EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.

University/college degree in a scientific discipline is required.  An advance degree (e.g. Masters, MBA, MD, PhD) is preferred.

 

10 years or more experience in clinical development and Medical Affairs, including Managed Access and with Leadership Competencies, along with a proven track record of global clinical operational experience or strong clinical project management experience in biotech, pharma or CRO environment.

 

Excellent people leadership skills in a matrix environment is required, people management experience is strongly preferred.

 

Willingness and ability to travel up to 20% of the time, defined by business needs.

 

Solid knowledge of global regulatory, quality and logistical aspects of global and local clinical programs is required.

 

Sound clinical financial acumen; experience with managing budgets is required.

 

Following skills are required to be considered further:

·       Trusted, inclusive, leader with demonstrated experience in managing/ mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness.

·       Is able to balance the customer needs and the business demands.

·       Ability to provide strategic leadership, proven decision making skills, strong negotiating and conflict resolution skills

·       Excellent communication and influencing skills and ability to establish strong relationships in a global matrix environment as well as the innate flexibility to work in a rapidly growing and changing organization.

·       In addition, the following competencies are required: collaboration and teaming, integrity and Credo based-actions, results and performance driven, sense of urgency, managing complexity, analytical skills, customer and external orientation.

 

Full understanding of all logistical aspects when running Managed Access programs regionally and locally, and good understanding on the therapeutic areas where J&J is involved.


Qualifications
1.     POSITION TITLE:  MAO Clinical Program Leader (CPL) – Managed Access (MAc) (PG 40)

2.   POSITION SUMMARY: Briefly state the objective of this position.

The MAO CPL is accountable for the successful planning, execution and reporting of a portfolio of assigned local, regional and/or global MAc programs (including Post Approval access, Post Trial access and Pre-Approval Access initiatives such as Named Patient Programs (NPPs) and single patients requests (SPRs)), across all TAs. This includes adequate resource planning and allocation, meeting deliverables within agreed timelines, budget, and with high quality per company procedures and regulatory requirements. 

 

The MAO CPL-MAc acts as the single point of end-to-end accountability within GCDO-MAO at the overall portfolio/program level and has strong leadership accountability to lead high performing teams.  The position serves as the key contact for and managing relationships with global, regional and local Business Partners (e.g. Medical Affairs and R&D), other internal Business Partners (eg. CF&A and FP), and external suppliers.

 

The MAO CPL-MAc is responsible for coordinating all activities within R&D Operations (RDO) and other key subject matter experts [e.g. Global Medical Safety (GMS)].

 

The MAO CPL-MAc leads and supervises a team of Associate Director Global Trial Managers (AD GTMs), Global Trial Managers (GTMs), Trial Managers (TMs) and Global Trial Manager Clinical Trial Assistants (GTM-CTA) and ensures consistencies across MAcs and leverages synergies and innovative approaches across portfolio/programs.

 

This MAO CPL-MAc is accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering  a diverse work force that works seamlessly in a highly matrixed environment.

PRINCIPAL RESPONSIBILITIES: 

·       Is the single point of accountability for the overall MAc program portfolio. Provides strategic operational expertise and leadership to    ensure operational delivery of MAc programs with regards to time, quality and budget.

 

Oversees the budget forecasting and management inclusive of OOP and FTE estimates. Partners with the AD GTMs for project related milestones and adequate resources. Ensures effective resource availability and assignments for MAc programs.

 

Oversees the Request for Service (RFS) process and partnerships with Clinical Forecasting & Analytics (CF&A) and other functions if appropriate (e.g. Pharmaceutical Development & Manufacturing Sciences).

 

Ensures  operational consistency across all MAc programs within the portfolio/program, working with the Global Operations Lead and regions.

 

Promotes optimal communication between the AD-GTMs/GTMs/TMs/GTM-CTAs and GCDO functions, if appropriate, internal Business Partners, and other key subject matter experts experts [e.g. Global Medical Safety (GMS)]). Ensures timely provision of status updates on project deliverables to the Business Partners and/or other enterprise sectors, as applicable.

 

Provides leadership to plan and/or define risk mitigation strategies and ensures implementation.

 

Communicates regularly with the Global Operations Lead (GOL) on all issues and risks related to project resources, timelines and budget. Makes recommendations for solutions and aligns with the GOL, as appropriate, on the action plan. Work with relevant project stakeholders/management teams to implement solutions/action plans.

 

Ensures project objectives are met according to all applicable regulations, legislations, guidelines and internal SOPs/policies.

 

Accountable for managing and developing staff within his/her scope of responsibility to meet enterprise wide leadership standards for current and future employment opportunities while fostering  a diverse work force that works seamlessly in a highly matrixed environment.

 

As applicable, acquire and sustain advanced knowledge of  appropriate therapeutic area(s), product and project setting.

 

Establishes strong relationships with COHs, other CPLs and GOLs within GCDO across all regions and therapeutic areas.

 

Provides recommendations to functional manager on functional and project execution strategies, and people management-related topics. Is pro-active in defining continuous improvement initiatiatives that help further shape the organization, and take a lead role in the execution and deliver of some of these initiatives.

 

Contributes to the design, development, and evaluation of  operational processes and standards.

 

4.  RESPONSIBILITY FOR OTHERS(If applicable): Describe the nature of supervision exercised over others by this position.

 

The MAO CPL reports to the Global Operations Lead, Managed Access.

 

The MAO CPL is responsible for a team of Associate Director Global Trial Managers (AD GTMs), Global Trial Managers (GTMs), Trial Managers(TMS) and Global Trial Managers-Clinical Trial Assistants(GTM-CTAs).

 

ADDITIONAL RESPONSIBILITIES:

·       Provides timely and accurate updates and ensure transparency to GCDO Management and internal business partners on the delivery status of portfolio/program and contributes to Governance bodies as applicable

·       Leads and/or supports  GCDO and other cross-functional or cross-sector initiatives, as assigned and identification of innovation opportunities.

·       Responsible for interviewing and hiring of GCDO-MAO AD GTMs, GTMs, TMs, GTM-CTAs, as appropriate..

 

EMPLOYEES SUPERVISED: CHECK ALL RELEVANT

 

EXEMPT:               

NON-EXEMPT:     

PART-TIME:           

 

TEMPORARY:      

CO-OP:                   

CONSULTANT:     

 

 

5. WORKING RELATIONSHIPS/INTERFACE: Describe the primary working relationships (internal & external) and primary interfaces along with the frequency and purpose/nature. Describe the primary working relationships (internal & external) and primary interfaces.

·       Internal contacts: COHs, other CPLs, GTMs, TMs and GTM-CTAs, Global Medical Affairs Leads, Regional and Country Medical Affairs teams, Therapeutic Area (eg. Compound Development Leads, Study Responsible Physicians/Scientists), Patient support,  RDO COEs FP, PDMS, Finance , Legal,  Procurement (JRP), Quality Management & Training group; HCBI/HCC, and other J&J enterprise sectors, as applicable.

 

·       External contacts: external service providers and other partners

 

6. EDUCATION & EXPERIENCE REQUIREMENTS: Describe the minimum knowledge, skill and ability requirements for the position. Include any degrees or certifications which are required and/or desirable.

University/college degree in a scientific discipline is required.  An advance degree (e.g. Masters, MBA, MD, PhD) is preferred.

 

10 years or more experience in clinical development and Medical Affairs, including Managed Access and with Leadership Competencies, along with a proven track record of global clinical operational experience or strong clinical project management experience in biotech, pharma or CRO environment.

 

Excellent people leadership skills in a matrix environment is required, people management experience is strongly preferred.

 

Willingness and ability to travel up to 20% of the time, defined by business needs.

 

Solid knowledge of global regulatory, quality and logistical aspects of global and local clinical programs is required.

 

Sound clinical financial acumen; experience with managing budgets is required.

 

Following skills are required to be considered further:

·       Trusted, inclusive, leader with demonstrated experience in managing/ mentoring global, cross functional matrix teams and a proven ability to foster team productivity and cohesiveness.

·       Is able to balance the customer needs and the business demands.

·       Ability to provide strategic leadership, proven decision making skills, strong negotiating and conflict resolution skills

·       Excellent communication and influencing skills and ability to establish strong relationships in a global matrix environment as well as the innate flexibility to work in a rapidly growing and changing organization.

·       In addition, the following competencies are required: collaboration and teaming, integrity and Credo based-actions, results and performance driven, sense of urgency, managing complexity, analytical skills, customer and external orientation.

 

Full understanding of all logistical aspects when running Managed Access programs regionally and locally, and good understanding on the therapeutic areas where J&J is involved.


Primary Location
China-Beijing-Beijing-
Other Locations
Asia Pacific-Malaysia-Kuala Lumpur-Kuala Lumpur, Asia Pacific-Singapore-Singapore-Singapore
Organization
J&J (China) Investments Ltd A- Beijing Branch (7075)
Job Function
Clinical Trial Coordination
Requisition ID
1905763800W