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GALVmed – Associate Director, R and D (Product Development and Clinical Studies)

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Associate Director, R&D (Product Development & Clinical Studies)
LOCATION:
GALVMED NAIROBI OFFICE (WOULD CONSIDER GALVMED EDINBURGH OFFICE WITH SIGNIFICANT TRAVEL REQUIRED)

SALARY RANGE:
KES 7,600,000 – KES 9,000,000 P.A.
REPORTING LINE & KEY INTERFACES:
Reports to: Director, Research and Development (VITAL)
Direct Reports: Associate Manager, Clinical Research
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.


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.


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.
o Co-ordinate all study activities, including protocol writing, conduct, site monitoring and close out.
o Prepare study protocols, data capture forms, test article documentation and study reports
o Maintain study files in accordance with SOPs and regulatory requirements
o Coordinate/Oversee data management processes including data entry, review, tracking, verification, and validation
o Coordinate animal related study activities (i.e., clinical sampling, test article administration, and clinical observations).
o 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.


Closing Date for applications: 23rd March 2022
Start Date: As soon as possible Please send CV & covering letter to recruit@hcsafrica.com

• 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)


Essential
• 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).

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