Track 1 - Optimisation of existing vaccine candidates towards Phase I trials

Strategic research

WP1 (Peter Andersen), WP5 (Ann Rawkins) Selected number of promising candidate vaccines
Optimisation of delivery and composition Evaluation of safety, immunogenicity, and protective efficacy in relevant animal models.
Second generation vaccine candidates for downstream development in Phase I trials

WP4 (Tom Ottenhoff)
Identify and develop human correlates of protection
Identify and develop markers of TB disease and TB immunopathology
Impact on the time and resources for evaluation of vaccine candidates in future clinical trials and early identification of the most effective vaccines

 

 

Downstream development

WP6 (Paul-Henry Lambert)
GMP production,
Regulatory aspects of vaccine development (ao. pre-clinical files)
Phase I clinical trials, in TB endemic and non-endemic areas Selection of candidates for further trials (involvement of EDCTP)

 

Track 2 - New vaccines/antigen discovery

WP2 (Carlos Martin)
Optimisation of (three) selected live vaccine candidates that showed a distinct, improved efficacy as compared to BCG and show promise as vaccines in infants Identification and effects immunomodulatory ligands
Selection of candidates/ligands for downstream development to Phase I trials

WP3 (Stefan Kaufmann)
Innovative back-up research to identify and develop novel vaccines/antigen components with a primary focus on subunit vaccines based on dormancy related antigens

Optimisation and downstream development

 

JOB OFFER / PROJECT MANAGER IN VACCINE DEVELOPMENT


The goal is to develop a live vaccine against tuberculosis within the University of Zaragoza, Microbiology Department, Faculty of Medicine. We are looking for a Project Manager with the following responsibilities.


Product development plan
- Translate the project strategies and objectives into a planning of activities.
- Contribute to the preparation of the Product Development Plan with strategies, objectives, schedules and major steps of development.
- Use the product development plan to prepare technical and operational work plan with well-timed activities and resources need. Create planning / Gantt charts for the project.
- Analyze risks and opportunities, anticipate pitfalls, list deliverables, and assist in establishing the criteria for making decisions.


Implement and monitor workplan
- Assist Project Director in structuring and setting up the Project Team and its sub teams as well as in organizing operations.
- Organize regular technical meetings and reviews done by the project and technical teams. Prepare agendas and take the write minutes of the meetings. Include a list of actions and assignments. Distribute minutes and reports.
- From the work plan as a reference, monitor progress of activities, quality of deliverables, timing, and cost.
- Within the Project Team, report progress, status according to plan and forecast. Highlight changes or delay, and flag risks and pitfalls. Develop corrective actions and plans to mitigate risks.
- Update Gantt as needed.
- Interact with PM, partners, consultants and contractors as needed.
- Assist the Project Director in reviews by Committees.
- Participate in quarterly and annual project reviews.
- Coordinate and contribute to the writing of proposals, reports, project descriptions, and scopes of work, as requested.


Experience and Skills
- PhD in life sciences or commensurate experience.
- Scientific background in the science related to vaccines.
- At least 5 years of experience in project management of vaccine development, preferably from the bio-pharmaceutical industry.
- Experience in managing multiple projects in an integrated way.
- Superior organizational skills.
- Strategic and analytical thinking.
- Ability to work in a multinational and multi-cultural environment with project teams, in a matrix organization.
- Excellent verbal and written communication skills.
- Being skilled in Microsoft Project is highly desirable. Use of web-based information sharing is a plus.
- Commitment to PATH’s mission and objectives.
- Experience with international projects is desirable.
- Knowledge of GLP, GCP and/or quality assurance and regulatory affairs associated with vaccine development is desirable.

We offer: A year-contract starting on April 2008, renewable for a second one. Submit a statement of scientific interests and accomplishments, the names and addresses of at least three references and a curriculum vitae to Dr. Carlos Martin Department of Microbiology, Faculty of Medicine, University of Zaragoza, Calle Domingo Miral, Zaragoza 50009, Spain. Electronic applications encouraged; send to tbvac.manager@unizar.es. Applications will be reviewed beginning March 1, 2008.