Attention recruitment agencies:
All agency inquiries are vetted through 4DMT’s internal Talent Acquisition team. No unsolicited resumes will be accepted. The 4DMT Talent Acquisition team must expressly engage agencies on any requisition. Agencies contacting hiring managers directly will not be tolerated, and doing so may impact your ability to work with 4DMT in the future.4DMT is a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines. We seek to unlock the full potential of gene therapy using our platform, Therapeutic Vector Evolution (TVE), which combines the power of directed evolution with our approximately one billion synthetic AAV capsid-derived sequences to invent evolved vectors for use in our products.
We believe key features of our targeted and evolved vectors will help us create targeted product candidates with improved therapeutic profiles. These profiles will allow us to treat a broad range of large market diseases, unlike most current genetic medicines that generally focus on rare or small market diseases. Company Differentiators: • Fully integrated clinical-phase company with internal manufacturing• Demonstrated ability to move rapidly from idea to IND• Five candidate products in the clinic and two declared pre-clinical programs• Robust technology and IP foundation, including our TVE and manufacturing platforms• Initial product safety and efficacy data substantiates the value of our platforms• Opportunities to expand to other indications and modalities within genetic medicine
GENERAL SUMMARY:
The Clinical Supply Specialist (CSS) will report directly to the Sr. Manager, Clinical Supply Chain and will manage clinical trial materials for Phase 1 and 2 clinical trials (with minimum supervision), as outlined in the Responsibilities section. Cross-functionally, CSS will mostly interact with Quality, Clinical Operations, and Manufacturing teams. CSS will be working hybrid and reports onsite as needed.
RESPONSIBILITIES:
Management: 60% of TIME
- Management of Phase 1 and 2 clinical trial materials planning and execution.
- Accountable for communication, support, and issue resolution for site-facing drug supply management processes and on-site drug supply issues.
- Collaborate with Clinical Operations to generate, maintain and circulate regular supply forecast and drug consumption reports.
- CMO Management. Plan and coordinate clinical supply activities including labeling, packaging, distribution of clinical trial supplies, randomization, and drug accountability systems control.
- Participate in supply chain business process development project.
- Drive continuous operational performance improvement efforts.
- Ensure compliance with Good Manufacturing Practices and applicable state and federal regulatory authorities.
Routine Work: 40% of TIME
- Monitor inventory levels at the depot and escalate to Supply Chain management any potential issues (shortfalls, overstock, expiration dating)
- Oversee distribution activities to clinical sites. Review of clinical supply requests, placing ancillary supply orders, and communicating IP.
- Generate and maintain various clinical supply inventory reports.
- Arrange shipping of bulk clinical supply and ancillary supplies to Contract Manufacturing Organization (CMO) or depot.
- Assist in filing CMC related documentation in eTMF.
- Perform other duties as assigned.
QUALIFICATIONS:
Education:
- Bachelor’s degree in supply chain or health care/biotech related fields
Experience:
- 5+ years of experience overall (in the pharmaceutical Industry) with 2+ years being in clinical or commercial supply chain management or clinical operations in Life Science or similar industry.
- Requires working knowledge of cGMP, cGLP, and regulations applicable to the FDA and comparable international regulatory agencies.
Skills:
- Demonstrated ability to work accurately, meet timelines and handle multiple priorities
- Excellent interpersonal, verbal, and written communication skills. Able to work efficiently and effectively collaborating with colleagues and SC vendors.
- Problem solving & adaptability. Strong attention to detail
- Self-driven. Proven ability and desire to learn.
- Able to perform well in a fast-paced and challenging environment.
- Basic understanding of logistics management.
- Proficient in Microsoft Applications (Word, Excel, PowerPoint, Projects, etc.)
- Experience in import/export of clinical supplies or knowledge in applicable area.
Compensation Range: $109,000/year - $141,000/yearPlease note, the base salary compensation range and actual salary offered to the final candidate depends on various factors: candidate’s geographical location, relevant work experience, skills, and years of experience.4DMT provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, status as a covered veteran, and any other category protected under applicable federal, state, provincial and local laws.Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
