Program Lead
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Zuid-Holland Netherlands.
In addition to the PML accountabilities listed above, the CPML role is accountable to CT Leader to utilize best-in-class Clinical program management support to provide end-to-end oversight of the Clinical program strategy, and management for initiating, planning, executing, controlling, reporting, and terminating the integrated Clinical development plan.
- Drive the CDT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making—the PML challenges the status quo and leads innovation.
- Manage the CDT in a manner that fosters and maintains a high performance team culture; at the direction of the CDTL, chair CDT meetings and represent the CDT to the Company at large, governance meetings, co-development partnerships, and external meetings such as Health Authority or Advisory Meetings.
- Works with other R&D departments to establish processes and procedures that facilitate activity, resource and cost planning across the R&D project portfolio.
- Co-leads the CT. The Clinical Leader/ Global Medical Leader drives strategy, and the CPML leads the team to operationalize that strategy (including scenario planning, stage gate approvals and setting priorities) and optimize the Clinical plans through constructive challenge and continuous dialog with the different functions to ensure all activities are aligned with the Compound Development Team goals and objectives. Th CPML ensures documentation of Clinical team meetings, key decisions, action items and cross functional communication (e.g., SharePoint, Teamworx).
- Partner with cross functional leads (TA, GCDO, Statistics, Clinical Pharmacology, Biomarkers, Clinical Supplies, Global Medical Safety, Finance, Regulatory) at the Clinical program level to assure end to end Clinical program oversight; and to identify and mitigate risks and issues in order to maintain quality, timelines, resources and budget.
- Collaborate with Clinical Team partners (TA, Medical Writing, RA, etc.) and provide oversight in the design, development and submission of key Clinical documents including the protocol, study reports and appendices. Gain cross-functional alignment to assure that risks are identified, key issues are resolved and the timelines are maintained. Take a lead role in ensuring Clinical readiness for stage gate reviews and governance reviews and decisions.
- Partner with the Program Coordinator (PC), Finance and the PMT to manage the overall Clinical program planning and budget (FTE + OOP) on an ongoing basis as well as during business plan cycles. Drive integration of the overall Clinical budget with TA, GCDO, CSU and functional representatives. In conjunction with PMO partners, provide input and/or review of periodic reports to management.
- Post-graduate degree in life sciences, engineering, or business management is preferred.
- Professional project management certification and/or diploma is preferred.
- A minimum of 1-3 years of industry/business experience, including a minimum of 1-3 in pharmaceutical R&D, is preferred.
- Prior experience as a member of a cross-functional team is preferred.
- A minimum of 1-3 years of experience in project management, team leadership, and/or functional line management in one or more of the major R&D functions is preferred; cross-functional experience is preferred.
- Demonstrated ability to resolve conflict and influence teams without formal authority is required.
- Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.
- Experience in planning and / or management of regulatory submissions (e.g., IND/CTA, NDA, MAA, etc.) is preferred.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
The Company
Our client is a professional Pharmaceutical organisation, based in Netherlands. In our organization, entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are of crucial importance. We are continuously looking for enthusiastic, talented people who have the ambition to develop themselves.Role Description
The PML is accountable to both the PMO leadership and the Compound Development Team Leader or Research Team Leader for initiating, planning, executing, controlling, reporting, and terminating the integrated, end-to-end (E2E) compound development plan as approved by the appropriate governing body. As a member of the Compound Development Team or Research Team, the PML provides cross-functional operational and program management leadership for the development of therapeutic products or non-interventional healthcare platforms in a global, matrix organization, from target validation to life cycle management.In addition to the PML accountabilities listed above, the CPML role is accountable to CT Leader to utilize best-in-class Clinical program management support to provide end-to-end oversight of the Clinical program strategy, and management for initiating, planning, executing, controlling, reporting, and terminating the integrated Clinical development plan.
Responsibilities
- The PML works in partnership with the CDTL/DASL to achieve the following results: o Establish the CDT/DAS strategy with concomitant goals & objectives in alignment with the organizational objectives. Contribute to and coordinate compound strategy updates over time; provide context and history to new CDT members/stakeholders.- Drive the CDT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating issue identification and resolution, problem-solving, risk management, contingency planning and decision-making—the PML challenges the status quo and leads innovation.
- Manage the CDT in a manner that fosters and maintains a high performance team culture; at the direction of the CDTL, chair CDT meetings and represent the CDT to the Company at large, governance meetings, co-development partnerships, and external meetings such as Health Authority or Advisory Meetings.
- Works with other R&D departments to establish processes and procedures that facilitate activity, resource and cost planning across the R&D project portfolio.
- Co-leads the CT. The Clinical Leader/ Global Medical Leader drives strategy, and the CPML leads the team to operationalize that strategy (including scenario planning, stage gate approvals and setting priorities) and optimize the Clinical plans through constructive challenge and continuous dialog with the different functions to ensure all activities are aligned with the Compound Development Team goals and objectives. Th CPML ensures documentation of Clinical team meetings, key decisions, action items and cross functional communication (e.g., SharePoint, Teamworx).
- Partner with cross functional leads (TA, GCDO, Statistics, Clinical Pharmacology, Biomarkers, Clinical Supplies, Global Medical Safety, Finance, Regulatory) at the Clinical program level to assure end to end Clinical program oversight; and to identify and mitigate risks and issues in order to maintain quality, timelines, resources and budget.
- Collaborate with Clinical Team partners (TA, Medical Writing, RA, etc.) and provide oversight in the design, development and submission of key Clinical documents including the protocol, study reports and appendices. Gain cross-functional alignment to assure that risks are identified, key issues are resolved and the timelines are maintained. Take a lead role in ensuring Clinical readiness for stage gate reviews and governance reviews and decisions.
- Partner with the Program Coordinator (PC), Finance and the PMT to manage the overall Clinical program planning and budget (FTE + OOP) on an ongoing basis as well as during business plan cycles. Drive integration of the overall Clinical budget with TA, GCDO, CSU and functional representatives. In conjunction with PMO partners, provide input and/or review of periodic reports to management.
Requirements
- A minimum of a Bachelor’s degree is required- Post-graduate degree in life sciences, engineering, or business management is preferred.
- Professional project management certification and/or diploma is preferred.
- A minimum of 1-3 years of industry/business experience, including a minimum of 1-3 in pharmaceutical R&D, is preferred.
- Prior experience as a member of a cross-functional team is preferred.
- A minimum of 1-3 years of experience in project management, team leadership, and/or functional line management in one or more of the major R&D functions is preferred; cross-functional experience is preferred.
- Demonstrated ability to resolve conflict and influence teams without formal authority is required.
- Successful experience managing or leading global and/or virtual teams is preferred, especially if done within a matrix organization.
- Experience in planning and / or management of regulatory submissions (e.g., IND/CTA, NDA, MAA, etc.) is preferred.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
