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Job Category:Chemical Manufacturing & Control

Who We Are

Dart NeuroScience LLC (DNS) is a privately held company with offices in San Diego, CA.
 
DNS is a company discovering new technologies and developing new therapies to help maintain cognitive vitality throughout life. DNS's mission is to become the leading specialized pharmaceutical company for memory disorders by focusing on the discovery and development of innovative drugs with new mechanisms of action. These discoveries are firmly based in a careful examination of the genes involved in the reorganization of synaptic connections in the brain, a cellular/molecular process which underlies both implicit (motor skills) and explicit (facts and events) forms of memory.
Our unique company culture engages employees by promoting thought-provoking investigation and targeted research opportunities. Our collegial environment also recognizes the value of stimulating cross-functional communication and collaboration as catalysts in generating the creative spark that inspires novel approaches and produces ground-breaking results. We want to attract, retain, and reward the top talent in our field. If you are looking for a productive, meaningful career path in the area of neuroscience, we would like to hear from you!


Job Summary:

The Manager of Clinical Trials Materials (CTM) Management is responsible for overseeing and ensuring the clinical supply needs for multiple clinical development programs. The successful candidate will work closely with Clinical Development, Clinical Operations, Regulatory Affairs, Manufacturing, and Quality Assurance to make certain that CTM are available for ongoing studies. To support programs, the manager will identify, negotiate, and manage packaging, labeling and distribution CROs who will provide the primary logistics of CTM supply to support both domestic and global studies. Additionally, he/she will track inventory levels to ensure demand requirements are met, safeguard against expiry dates lapses that could cause study delays, and handle re-supply of CTM in a seamless fashion. The manger will contribute to the development, review and acceptance testing of IRT systems, work closely with Clinical Operations to monitor and review enrollment plans and modify supply chain logistic plans as required.

Roles and Responsibilities:
• Coordinate logistics and distribution of CTM for both U.S. and international clinical studies
• Identity, negotiate with, and manage CROs and vendors that will package, label, and distribute CTM for worldwide clinical trial
• Review clinical trial protocols and understand their impact on CTM
• In collaboration with Clinical Operations, identify demand assumptions, enrollment rates, number of sites, number of countries to understand CTM requirements
• Collaborate with Manufacture and Quality to ensure that CTM manufacture and release meet the needs of clinical studies
• Work directly with IRT vendors to define specification, acceptance, and implementation of the IXRS
• Monitor inventory levels and expiry dates of CTM at depots and clinical sites throughout the duration of clinical studies to proactively prevent downstream supply issues
• Manage CTM label development and approval process
• Provide guidance towards and implement of packaging and supply strategies to maximize supply efficiency and minimize waste
• Develop risk mitigation strategies and provide contingency plans to minimize delays to study conduct
• Apply simulation tools to drive optimal clinical supply plan as appropriate
• Regularly update development project teams on ongoing CTM requirements and status
• Contribute to yearly budget generation
• Write and review SOPs, where appropriate
• Establish and maintain a strong, collaborative working relationship with internal and external stakeholders to ensure customer satisfaction

Qualifications/Requirements:

• Bachelors in life sciences, Masters preferred
• Minimum 5 years in life sciences industry related experience, including Project Management, Pharmaceutical Development, Clinical Supply Management, and/or Clinical Trials Coordination
• At least 4 years direct experience in clinical supplies environment
• Proficient knowledge of Microsoft Excel, PowerPoint and Project software required
• APICS certification preferred

Physical Demands and Work Environment:
• Travel domestic and international – up to 15%

Competencies:
• Strong working knowledge of of clinical study design, implementation, and impact of CTM supply
• Familiarity with a variety of clinical trial designs (e.g. randomized, double-blind, double-dummy, placebo-controlled, open label.)
• Experience in inventory management and forecasting drug supply to support global trials
• Experience with IXRS systems, including direct knowledge of set-up and use of IXRS
• General understanding of GMP and GCP requirements for CTM
• Ability to adapt to modification and changes to clinical plans, demonstrating flexibility to implement new strategies and tactics to accommodate these changes
• Excellent communication and influencing skills, strong collaboration skills
• Strong attention to detail
• Ability to multi-task and manage complexity

Benefits:

DNS offers competitive salaries and a great benefits package including paid holidays, incentive bonuses, healthcare, vision, dental, long-term disability, life insurance, flexible spending, and a 401(k) retirement savings plan. Click here to learn more.


Dart NeuroScience is an Equal Opportunity Employer/Minorities/Women/Disability/Veterans.

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