Clinical Supply Manager
| Company | 4D Molecular Therapeutics |
|---|---|
| Location | Oakland, CA, USA |
| Salary | $125000 – $177000 |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior |
Requirements
- A bachelor’s degree in supply chain management, life sciences, healthcare, or a related field is required.
- A minimum of 5 years of relevant experience in clinical supply chain management or a similar position within the pharmaceutical or biotech industry.
- Proven track record in overseeing supply logistics for international clinical trials. Experience with trials outside of the US is essential.
- Solid understanding of cGMP, cGLP, and FDA/EMA regulations, along with knowledge of international regulatory standards, import/export requirements, and international requirements for genetically modified organisms (GMOs).
- Strong planning and organizational skills with the ability to handle multiple concurrent projects and tight timelines.
- Exceptional communication skills—both verbal and written—with the capacity to explain complex concepts effectively.
- Demonstrated ability to analyze data and solve problems efficiently.
- Takes initiative in identifying potential issues and implementing timely corrective actions.
- Capable of working collaboratively in a cross-functional team setting.
- High attention to detail and a commitment to maintaining compliance and product integrity.
Responsibilities
- Design and implement supply strategies that align with clinical development timelines and protocol requirements.
- Collaborate with internal teams to facilitate the prompt acquisition and delivery of study materials.
- Track supply levels and conduct periodic inventory checks to ensure accurate records and appropriate storage conditions.
- Manage relationships with third-party suppliers, including contract negotiations and ongoing performance evaluation to ensure consistent supply quality.
- Verify that all supplies comply with regulatory standards. Ensure meticulous record-keeping to support audits and regulatory inspections.
- Work closely with colleagues in CMC, Clinical Operations, Quality, Regulatory Affairs, and other departments to synchronize supply chain efforts with overall project goals.
- Proactively assess vulnerabilities within the supply chain and implement strategies to prevent or resolve potential disruptions.
- Administer supply-related budgets, aiming to reduce costs while maintaining timelines and quality standards.
- Generate detailed reports summarizing supply chain activities, identifying risks, and tracking key performance indicators.
Preferred Qualifications
- Experience with global supply logistics, including knowledge of import/export processes, is a plus.