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ASSOCIATE DIRECTOR, R&D (PRODUCT DEVELOPMENT& CLINICAL STUDIES)

Posted 3 months ago

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.

Job Location: Nairobi, Kenya

Key Activities

  • 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.
  • Manage assigned R&D project budgets through proactive intervention to achieve alignment with budget forecasts
  •  Create product development plans to fit specific assigned and future R&D project objectives.
  • 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.
  • Lead assigned R & D projects to product development and registration and achieve the objectives of the funded projects within timelines.
  • 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.
  • Map out and maintain awareness of relevant scientific literature to aid success of assigned product development projects.
  • Maintain accurate records on assigned projects and issue reports as per project milestones
  • Design internal studies in consultation with Director R&D (VITAL) and in collaboration with R&D partners
  • Manage GALVmed clinical operational staff.
    • Co-ordinate all study activities, including protocol writing, conduct, site monitoring and close out.
    • Prepare study protocols, data capture forms, test article documentation and study reports
    • Maintain study files in accordance with SOPs and regulatory requirements
    • Coordinate/Oversee data management processes including data entry, review, tracking, verification, and validation
    • Coordinate animal related study activities (i.e., clinical sampling, test article administration, and clinical observations).
    • Monitor all studies appropriately including training of investigators and other study personnel.
  • Serve as the clinical communication link between GALVmed, the sponsor and study site.
  • 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.
  • Manage functions of GALVmed study monitor, archivist, SOP coordinator and study number allocator for the R & D Group
  • 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
  • Contribute to scientific manuscript writing and/or review.
  • 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)

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

TRAVEL:

Significant amount of travel around Africa

To Apply:   

Applicants who meet the requirements stated above should send their applications and detailed CVs with a day – time Telephone number to the email address: recruit@hcsafrica.com  with Associate Director, R&D on the Subject line. Candidates MUST indicate their Current and Expected salaries

Only shortlisted will be contacted

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