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Clinical Program Leader

北京, 中国; Kuala Lumpur, 马来西来; Singapore, 新加坡
Clinical Trial Coordination


Requisition ID: 1905763800W

TITLE: Clinical Program Leader, Managed Access (Medical Affairs Operations)


=============== DESCRIPTION ===============:


Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Medical Affairs Operations Clinical Program Leader, Managed Access with location in China, Singapore or Malaysia.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.


Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases, and pulmonary hypertension. Please visit for more information.


We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.


The Medical Affairs Operations Clinical Program Leader (MAO-CPL), reporting to the Global Operations Lead for Managed Access is accountable for successful operational planning, setup and execution of Managed Access initiatives within the assigned therapeutic areas (TAs). This in alignment with regional and local regulations and Janssen policies and processes. Managed Access initiatives include Post-Trail Access and Pre-Approval Access initiatives such as Named Patient Programs (NPPs) and Single Patients Requests (SPRs).


The MAO-CPL for Managed Access acts as the single point of end-to-end accountability within GCDO-MAO for the portfolio of the assigned TAs and the ASPAC region. In this role, you will lead and oversee operational planning and execution of Managed Access initiatives and strategic projects in coordination with OCMO, GCSO, TAs and GCDO colleagues, such as Patient Support, TA leads, CDTLs, GMALs, and regional MAF, and external suppliers.


The MAO-CPL is accountable for managing and developing a global team while fostering a diverse work force that works seamlessly in a highly matrixed environment, and ensures consistencies across Managed Access initiatives, and creates and leverages synergies and innovative approaches.




·       Provides strategic operational expertise and leadership to ensure operational delivery of Managed Access initiatives with regards to time, quality and budget, and ensure operational consistency across programs and regions.

·       Performance and development of employees within the department, including clear goals and objectives setting, performance management, training plans, succession planning and employee development plans.

·       Oversees the budget forecasting and management, and partners with the Global Trial Managers for project related milestones and adequate resources (incl. effective resource availability – hiring -and assignment).

·       Regular and ad-hoc Managed Access initiative reporting to Global Operations Lead and initiative sponsors.

·       Ensure compliance with regional and local regulations, guidelines and internal operating procedures and processes.

·       Provides leadership to pro-actively plan and/or define risk mitigation strategies and ensures implementation in collaboration with business partners and external vendors.

·       Contributes to the design, development, and evaluation of operational processes, and is pro-active in defining continuous improvement initiatives that help further shape the organization.

  • Leads CRO selection, ensures scope of work is defined and is responsible to define deliverables, turnaround times, and quality and performance levels for new sourcing needs.

·       Primary point of contact for Managed Access within ASPAC and contributes to strategic access efforts within the region, aligned with the global strategy.



=============== QUALIFICATIONS ===============:


·       A minimum of University/College degree in Life Sciences (e.g. Biology, Chemistry, Pharmacy, Biochemistry, Nursing) is required. An advance degree (e.g. Masters, MBA, MD, PhD) is preferred.

·       A minimum of 10 years of experience in clinical development and Medical Affairs, including Managed Access.

·       Proven track record of global clinical operational experience or strong clinical project management experience in biotech, pharma or CRO environment.

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

·       Excellent people leadership skills, managing global or regional teams in a virtual matrix environment is required.

·       Effective leadership and communication skills, with proven ability to effectively manage stakeholders, foster team productivity and create cohesiveness.

·       Ability to balance the customer needs and the business demands, collaborate, be results and performance driven, have a sense of urgency and manage complexity and strong decision making.

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

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

·       Solid understanding of the Managed Access landscape in the ASPAC region.

·       Profound understanding of the Janssen TA portfolio, with strong Oncology experience is preferred.

亚太地区-马来西来-Kuala Lumpur-Kuala Lumpur, 亚太地区-新加坡-Singapore-Singapore
J&J (China) Investments Ltd A- Beijing Branch (7075)
Clinical Trial Coordination
Requisition ID