AD/Dir of Clinical Trial Supply Management
- Posted: 12 days ago
Founded in 2014 and based in Rockville, MD, NeoImmuneTech (NIT) is a clinical-stage T cell-focused biotech company dedicated to the discovery and development of novel immuno-therapeutics. At NIT, we strive to expand the therapeutic horizon in Immuno-Oncology and Infectious Diseases by greatly reducing the fatality and morbidity of life-threatening and debilitating diseases. Led by our scientific founder, who invented our lead asset NT-I7 (efineptakin alfa), we are science driven and patient focused. We believe that with NT-I7, the only clinical-stage long-acting human IL-7, we can enhance the body’s immune function to address key resistance mechanisms in Immuno-Oncology and deadly infectious diseases. We have a profound belief, rooted in our science, that we have the power to transform patient care with unique assets like NT-I7, and are committed to the pursuit of discovering their full potential in treating various diseases.
- Hybrid work opportunity
- Competitive pay
- Annual promotion opportunities
- 401(k) + company matching - 100% vests immediately!
- Free medical insurance
- Flexible Spending Account (FSA)
- Free life insurance
- Paid time off
- Paid holidays
- Paid sick leave
- Paid Family Medical Leave
- Free lunches, snacks, and drinks
- Cell phone reimbursement
- Internet reimbursement
The Associate Director/Director of Clinical Trial Supply Management will provide leadership and strategic operational oversight of clinical trial supply chain and manufacturing forecasting in support of the development pipeline, clinical and non-clinical trials. This role will work collaboratively with CMC, QA and other cross-functional teams and outsourcing partners to ensure that clinical trial supplies used in the execution of NeoImmuneTech studies meet operational demands in alignment with current regulatory standards and within agreed timelines and budgets.
- Translates trial design/protocol requirements to IP and ancillary supply requirements including alignment of forecasted demand with manufacturing schedules, packaging, labeling, logistics management, and procurement of ancillary supplies/comparators
- Provides and/or secures expertise for import/export requirements and timeframes for material shipments
- Accountable for overall on-time supply of product for trials
- Represents clinical trial supply function through attendance at program-level and/or trial-level meetings and discussions
- Identifies and hires appropriate clinical trial supply management resources to support current and future pipeline programs including outsourcing support
- Leads and/or assists in clinical trial supply-related vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners
- Manages the performance of external vendors for all aspects of clinical supply (e.g., procurement to return/destruction) according to contractual agreements and budget, ensuring quality standards are met
- Drives the development of clinical supply-related agreements and other relevant documents in partnership with appropriate functional areas; leads and/or assists with request, creation, and review of scope of work and budgets
- Develops in consultation with cross-functional partners clinical supply-related key performance indicators (KPIs) and key quality indicators (KQIs) to build into contractual agreements
- Participates in review of operational documentation including clinical protocols, clinical supply-related documents, templates, and manuals (e.g., IMPD, pharmacy manual, etc.); participates in the development of the relevant components of regulatory submissions
- Develops, forecasts, and manages function budget
- Oversees and/or ensures supply management systems (e.g., IRT) are designed and executed according to protocol design requirements and regulatory standards. When supply management systems are not used, will develop, maintain, communicate optimized manual process(es) to minimize risk and maximize efficiency
- Leads clinical trial supply-related program-level and trial-level operational risk identification, management, and mitigation efforts and report progress to senior leadership
- Establishes and implements inspection-readiness for supply-related documentation.
- Responds to and participates in Quality Assurance audits and/or regulatory authority inspections
- Contributes to the development and improvement of department-level and cross-functional Standard Operating Procedures (SOPs), work instructions, and other necessary processes, systems, tools (e.g., forms, templates).
- Manages internal staffing and performance management including hiring, training, coaching and performance reviews for clinical trial supply management staff. Mentors and develops staff.
- Other duties as assigned
- Bachelor’s degree required, advanced degree preferred in related field (e.g. pharmacy, biopharmaceutics, supply chain, engineering
- 10+ years of experience working in clinical research, clinical supply or closely related field with progressive management experience in manufacturing, clinical trial supplies and related vendors (minimum 4 years of clinical trial supply experience)
- Extensive experience managing third-party depots, budgets, and timelines is required
- Strong working knowledge of MS Project and developing Gantt charts / MS Excel
- Experience designing and managing inventory through use of IRT including experience with clinical blinding practices, inventory control is required
- Experience overseeing Investigator Initiated Trials highly desirable
- Demonstrated experience in complex project management and effective management of multiple projects/priorities
- Must have demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
- Experience in regulatory requirements for clinical material/IMP (e.g., IND, IMPD, CTA, etc.) required; experience in regulatory filings (e.g., NDA, BLA, MAA) required
- Previous involvement in the oversight and management of GxP regulatory inspections desired
- Excellent knowledge of ICH-GCP, GMP, regulatory requirements for management of clinical supplies
- Ability and willingness to travel up to 15% of the time, as needed (domestic and international)
- Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
NeoImmuneTech, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
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