Medical Product Development Team Lead
2 weeks ago
The successful candidate will lead the drug development processes workstream for the market-shaping output, working closely with CHAI and other stakeholders to drive product development and quality assurance processes.
Key Performance Areas- Lead the drug development processes workstream, ensuring efficient and effective strategies are implemented to accelerate preclinical and clinical research and product development.
- Work closely with CHAI's US-based product development and regulatory team to develop plans to accelerate generic product development, assess and mitigate product development risks with generic partners, and support innovative regulatory strategies.
- Engage in job shadowing during technical meetings with generic manufacturers and strategy development, developing and maintaining strong working relationships with CHAI, manufacturers, and other stakeholders.
- Convene and/or attend and lead drug development and regulatory stakeholder meetings, ensuring coordination with the supplier engagement and contract management workstream.
- Oversee the planning and coordination of the drug development workstream, ensuring optimal staff utilization and maintenance of sound labor relations.
- Line manage and give day-to-day direction to one project manager: drug development processes, and dotted line management of two other positions (project administrator and project statistician).
- Attend manufacturer site visits as necessary, reporting monthly on key achievements, challenges, and any anecdotal success stories.
- Contribute to and support financial management and control as related to the above human resources and other activities.
- Plan, convene, and produce reports for monthly one-on-one meetings with supervised staff to monitor performance and support.
- Attend to all staffing requirements and administration, ensuring a positive attitude and responding openly to feedback.
- A Graduate-level Technical Degree with significant experience in medical product (drug) development commercialization.
- Minimum 8 years of private sector work experience, with a focus on medical product (drug) development and commercialization.
- Successful experience accelerating preclinical and clinical research and product development by implementing efficient and effective drug development strategies for these products.
- Experience developing strategies to overcome key barriers and issues related to product development, filing, approval, introduction, and adoption.
- Extensive experience managing relationships with manufacturers, procurement and other partners, Stringent Regulatory Authority (SRAs), National Drug Regulatory Authorities (NDRAs), Ministries of Health, and other key stakeholders.
- Ability to collaborate remotely with team members spread across geographies.
- Good interpersonal skills and ability to navigate complicated situations, excellent levels of written and verbal English communication skills, ability to communicate in other SA languages, preferably area-appropriate.
- Travel will be required within and outside of South Africa.
- Work can be highly demanding and pressurized, and requires flexibility, management, training, and leadership experience.
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