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 Chain Manager (CSCM) will report directly to the Senior Manager of Clinical Supply Chain and will manage global clinical trial materials for Phase 3 trials with minimal supervision, as outlined in the Responsibilities section. The CSCM will work cross-functionally, primarily interacting with Quality, Clinical Operations, and Manufacturing teams. This is a hybrid role, with onsite presence required as needed.
MAJOR DUTIES & RESPONSIBILITIES:
The CSCM will be responsible for overseeing end-to-end clinical supply chain operations throughout the lifecycle of clinical studies. The role encompasses, but is not limited to, the following areas:
- Supply Strategy & Execution: Design and implement supply strategies that align with clinical development timelines and protocol requirements.
- Cross-Functional Coordination: Collaborate with internal teams to facilitate the prompt acquisition and delivery of study materials.
- Inventory Oversight: Track supply levels and conduct periodic inventory checks to ensure accurate records and appropriate storage conditions.
- External Vendor Oversight: Manage relationships with third-party suppliers, including contract negotiations and ongoing performance evaluation to ensure consistent supply quality.
- Compliance & Documentation: Verify that all supplies comply with regulatory standards. Ensure meticulous record-keeping to support audits and regulatory inspections.
- Stakeholder Collaboration: Work closely with colleagues in CMC, Clinical Operations, Quality, Regulatory Affairs, and other departments to synchronize supply chain efforts with overall project goals.
- Risk Mitigation: Proactively assess vulnerabilities within the supply chain and implement strategies to prevent or resolve potential disruptions.
- Budget Oversight: Administer supply-related budgets, aiming to reduce costs while maintaining timelines and quality standards.
- Performance Reporting: Generate detailed reports summarizing supply chain activities, identifying risks, and tracking key performance indicators.
- Other duties as assigned, nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time
QUALIFICATIONS:
Education:
- A bachelor’s degree in supply chain management, life sciences, healthcare, or a related field is required.
Experience:
- 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.
- Experience with global supply logistics, including knowledge of import/export processes, is a plus.
Other Qualifications/Skills:
- 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.
Travel: 10%Physical Requirements and Working Conditions:
- Physical Activity - Repetitive motions: Making substantial movements (motions) of the wrists, hands, and/or fingers. Fingering: Picking, pinching, typing or otherwise working, primarily with fingers rather than with whole hand or arm as in handling. Talking: Expressing or exchanging ideas by means of the spoken word.
- Physical Requirements - Sedentary work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
- Working Conditions - The worker is not substantially exposed to adverse environmental conditions (as in typical office or administrative work).
Base salary compensation range: $125,000/yr-$177,000/yr4DMT 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
