• Leiden
  • 40 uur
  • WO
solliciteer via YACHT

Clinical Program Lead (Yacht Life Sciences)


  • 12 september 2018
  • Leiden
  • 40 uur
  • WO

functieomschrijving

  • 12 september 2018
  • vacaturenummer: 9057891

Yacht Life Sciences has a vacancy for a Clinical Program Lead (CPML).

The CPML works in partnership with the CL (Clinical Leader) to achieve the following results: 

  • Establish the Clinical strategy with concomitant goals and objectives in alignment with the organizational objectives. Contribute to and coordinate Clinical strategy updates over time; provide context and history to new CT members/ stakeholders. Mentor colleagues in CT best practices. 
  • Drive the CT to meet or exceed those goals by providing superior global cross-functional operational leadership and management in a matrix organization, facilitating Clinical issue identification and resolution, problem-solving, risk management, contingency planning and decision-making. The CPML challenges the status quo and leads innovation. 
  • Manage the CT in a manner that fosters and maintains a high performance team culture, and utilize team development best practices and facilitate lessons learned to ensure optimal performance. With the CL, co-chair CT meetings and represent the CT to the Company at governance meetings, co-development partnerships, and external meetings such as Health Authority or Advisory Meetings.
  • 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. 
  • If applicable, on co-development programs, work within the Joint Development Team or equivalent to manage and align cross company Clinical research activities and objectives. 
  • In collaboration with the Clinical and regulatory functions, work at the Clinical program level to drive the planning and preparation of Clinical documents required for successful Health Authority submissions, and clinically-related external committees and meetings such as Advisory Boards. 
  • Motivate colleagues through personal example, and dedication to team goals. Inspire confidence and build group trust. Use emotional intelligence to spot signals others miss. Keep group focused on strategy and goals despite complexity, controversy, or conflict. Build bridges between organizations; turn adversity into opportunities for change and growth. 
  • Contribute to the success of the PMO in achieving its goals and objectives by ensuring program work is conducted in compliance with PMO processes and Company policies, lead program management process and quality improvement initiatives and other tasks assigned by the PMO leadership team.
  • Primary duties listed above are not to be construed as exhaustive; other duties may be assigned by the PMO. 

Functie-eisen

  • Strong tracking, coordination and project planning skills
  • Ability to identify and implement process and/or application improvements
  • Strong analytical and problem-solving skills
  • Must be able to work on multiple simultaneous tasks with limited supervision
  • Quick learner, motivated self-starter
  • Excellent customer service, interpersonal, communication and team collaboration skills
  • Able to follow change management procedures and internal guidelines
  • Master and/or Bachelor Degree in Mathematics, Engineering, Computer Science, Chemistry or Bioinformatics OR equivalent through experience
  • Advanced course work in technical systems plus continued education in technical disciplines is preferred
  • Additional certification is a plus
  • Language proficiency: English spoken and written

Arbeidsvoorwaarden

This concerns a full-time secondment position via Yacht, temporary contract for 1 year (extension is not likely to happen at this moment).
This role can be performed by a freelancer/ ZZP'er as well.

Bedrijfsinformatie

Our client is dedicated to bringing meaningful innovation to global health. Their teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases. In their organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. To strengthen their team, they are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to the company. 

 

Contactinformatie

Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer 06-12387998

Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.

Uiteraard staat deze vacature open voor zowel mannen als vrouwen.

Deze vacature wordt via YACHT aangeboden. Het solliciteren en verdere contact verloopt via YACHT.