AddressAt Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.
The position is responsible for ensuring a compliant, uninterrupted end-to-end Clinical Supply of all Neumora’s clinical programs. This will include developing and implementing required Clinical Supply Chain procedures and infrastructure; global supply demand and inventory management; short- and long-term sourcing strategies, building and maintaining strong supplier relationships; and oversight of label development, package manufacturing, and finished clinical product distribution.
Provides strategic thinking, problem-solving, clear and concise communications, sound judgment, and tactical execution, all while exhibiting the highest standards.
Demonstrates the ability to effectively work across cross-functional teams, maintain project timelines, articulate proposed solutions and associated benefits across the organization, and successfully guide the implementation including all change management aspects.
This hands-on role requires an independent self-starter with strong experience in Clinical Supply Chain management. The role will be based out of our Watertown office with the possibility of remote work for the right candidate.
Responsibilities:
- Develop and implement Supply Chain management strategies to maximize Clinical Supply efficiency and minimize waste. Develop IMP demand and supply plans that support study timelines and incorporate risk mitigation plans to ensure timely and uninterrupted supply. Collaborate with other CMC teams to optimize end-to-end inventory strategies.
- Manage contract manufacturers performing primary packaging, labeling, and global distribution. Lead the evaluation, selection, and ongoing oversight of CMO operations to ensure they are effective members of Neumora’s global Supply Chain. Collaborate with QA for appropriate quality audits and evaluations.
- Lead the development of compliant IMP labels in collaboration with Clinical Operations, RA, and QA to ensure all label text and proofs follow applicable regulations, product specifications, and clinical study protocols.
- Perform demand and supply planning and forecasting for all Neumora’s development programs. Conduct supply planning scenarios to evaluate the impact of changing inventory targets, clinical demand, and budget needs.
- Collaborate with CMC Leads, Clinical Operations, and Regulatory Affairs (RA) on clinical studies program strategies, scope, and study demands, ensuring alignment with CMC capabilities, supply plans, and timelines. Ensure all plans effectively incorporate CMC capacity and lead times.
- Partner with Clinical Operations for evaluation and selection of CRO partners and IRT vendors. Collaborate regarding CRO capabilities to support study execution of IMP supply, including global depot networks and IRT functionality, as necessary.
- Collaborate with Clinical Operations and Data Management for the creation of User Requirements Specifications (URS) and effective end-to-end UAT testing. Ensure that the IRT is optimally configured and utilized effectively to maintain continuous IMP supplies.
- Manage the IMP global logistics network leveraging CMO and other logistics and global trade compliance business partners to ensure timely and compliant movement of Neumora’s IMP products.
- Serve as internal lead for triaging of product complaints, temperature excursions, and deviations originating from distribution vendors and clinical sites. Partners with Quality Assurance to resolve any quality-related items.
- Develop and implement logistics and planning tools through MS Project, spreadsheet, and/or relational databases for Supply Chain, Procurement, and Operations
- Create and maintain planning and logistics metrics to enable process improvements.
Qualifications:
- 15+ years of Pharmaceutical/Biotech specific industry experience and 10+ years of Clinical Supply Chain management experience with strong knowledge of related sourcing processes, tools/systems, policies, business intelligence and reporting platforms, and best practices.
- MS or BS in a scientific or business discipline.
- Management and logistics in the pharmaceutical industry with increasing scope of responsibilities.
- Solid understanding of global pharmaceutical regulatory requirements and clinical study management. Working knowledge of GMP/GCP/GLP regulations.
- Experience developing Supply Chain strategies, garnering support from other functional teams, generating support and commitment from Supply Chain team members.
- Knowledge of IRT functionality, system setup, and operation.
- Experience in IMP demand and supply planning, scenario planning, and risk modeling; proficiency with Excel-based models.
- Experience in recruiting and developing team members and creating a healthy, robust Clinical Supply Chain team.
- Strong experience in clinical label development, global shipping, and trade compliance.
- Excellent time management skills, and ability to prioritize effectively to deliver results within aggressive timelines with the ability to work independently and as part of a team.
- Previous experience in the biotech-pharmaceutical industry, with a strong understanding of the drug development and manufacturing process.
- Ability to effectively articulate recommendations and lead the implementation plan within the project budget and timelines.
- Strong project management skills. Understands the importance of defining and managing the critical path; brings solutions when needed to address potential delays.
- Exceptional cross-functional collaborator, both internally across Company functions and externally with strategic suppliers. Listens well, is open to objective discussion, and then moves forward with absolute commitment once recommendations and decisions are reached.
- Previous working knowledge of business intelligence and reporting tools; experience creating and automating custom reports and dashboards.
- Experienced in process improvement and continuous improvement methodologies.
- Understands the importance of supplier relationship management; tangible experience engaging with strategic suppliers and business stakeholders to drive a culture of continuous improvement and breakthrough innovations.
- Excellent communication and organizational skills.
Company benefits include:
- Medical, dental, vision, and life insurance
- 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
- New hire stock options
- Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
- Leave of Absence: Paid family leave, paid short- and long-term disability
- Discretionary year-end bonus
The salary range posted describes the minimum to maximum base salary range for this position in the location listed. Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer.
Base Salary Range: $201,461 - $259,641
Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases.
Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.
Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
