Associate Director, R&D (Product Development & Clinical Studies) at Human Capital Synergies

Our client, the Global Alliance for Livestock Veterinary Medicines (GALVmed)is a not-for-profit organization whose mission is to develop livestock vaccines and medicines to benefit smallholder livestock keepers in the developing world seeks to recruit an Associate Director, R&D (Product Development & Clinical Studies)

Main Purpose and Scope of the Job

To serve as Manager contributing to product development projects under the VITAL and future GALVmed R&D programmes.

The jobholder will also be responsible for initiating and managing implementation of regulatory and non-regulatory clinical and non-clinical trials as per GALVmed’s required standards.

Reports to: Director, Research and Development (VITAL)

Key Interfaces: Executive Director, R&D; Director, R&D (TAHSSL); TAHSSL management team and partners (ILRI, Clinglobal); Portfolio Managers; Project Leaders; Contracts management; GALVmed consultants; External clinical trial partners, Scientific Community.

Key Activities

1. Manage and contribute to achievement of objectives of VITAL, and future R&D projects as agreed with funders and in support of GALVmed 2030 Strategy.
2. Manage assigned R&D project budgets through proactive intervention to achieve alignment with budget forecasts
3. Create product development plans to fit specific assigned and future R&D project objectives.
4. Together with the Portfolio Manager, oversee the product development planning of assigned projects via MS Project to ensure transparent planning and communication of tasks and timelines.
5. Lead assigned R & D projects to product development and registration and achieve the objectives of the funded projects within timelines.
6. Ensure that all product development work under assigned projects is conducted in accordance with written and approved procedures/protocols, and in accordance with good scientific practices.
7. Map out and maintain awareness of relevant scientific literature to aid success of assigned product development projects.
8. Maintain accurate records on assigned projects and issue reports as per project milestones
9. Design internal studies in consultation with Director R&D (VITAL) and in collaboration with R&D partners
10. Manage GALVmed clinical operational staff.
11. Co-ordinate all study activities, including protocol writing, conduct, site monitoring and close out.
12. Prepare study protocols, data capture forms, test article documentation and study reports
13. Maintain study files in accordance with SOPs and regulatory requirements
14. Coordinate/Oversee data management processes including data entry, review, tracking, verification, and validation
15. Coordinate animal related study activities (i.e., clinical sampling, test article administration, and clinical observations).
16. Monitor all studies appropriately including training of investigators and other study personnel.
17. Serve as the clinical communication link between GALVmed, the sponsor and study site.
18. Act as a team leader of assigned projects as required, and to interact with external commercial and academic partners and funders to achieve efficient project progression and assessment.
19. Manage functions of GALVmed study monitor, archivist, SOP coordinator and study number allocator for the R & D Group
20. Contribute to the selection and management of consultants and partners as may be required from time-to-time for effective implementation of assigned GALVmed R&D projects.·         Represent GALVmed within the research and scientific community in Africa and South Asia through regular contact, and attendance and presentation at scientific meetings
21. Contribute to scientific manuscript writing and/or review.
22. Improve GALVmed’s performance by continuous review and improvement of R&D procedures to achieve the most efficient methods and procedures for product development.

 Qualifications / experience REQUIRED (in order to successfully carry out the job role)

1. Minimum:  PhD in Biological Sciences or equivalent
2. At least 5 years’ experience of product (essentially vaccine) development within a commercial environment
3. Familiarity with design & management of clinical trials in animals
4. Experience in conducting registration trials
5. Project Leadership and Management experience with demonstrated ability
6. Solutions driven, and creative·    Attention to detail & ability to prioritise work
7. Excellent team-player and ability to work across functions
8. Willingness to travel as needed, sometimes to challenging locations
9. Experience of working in low & middle income countries
10. Knowledge and experience on poultry diseases ((IB, IBD (Gumboro), FP, ND, Coccidiosis)

TRAVEL:

Significant amount of travel around Africa