Clinical Supplies Manager
Who We Are
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Team
The Clinical Supplies Manager will be performing the activities required to provide leadership and support in the planning, development, and execution of clinical supply chain activities and the ability to drive cross-functional deliverables and manage activities of supply partners and functions (e.g. packaging and distribution, depots, logistics). This person is instrumental in timely planning, accurate forecasting and managing investigational supplies for all phases of clinical trials. The position requires flexibility, teamwork, attention to detail, and rapid response to issues as they arise.
- Understand and translate clinical study protocol requirements into demand for drug product within a clinical study
- Create initial supply forecasts and re-forecast, as needed, based on study strategy or timeline changes
- Partner with cross functional groups to meet study start up timelines and countries activations
- Manage drug supply function within IRT; including releasing lots, managing shipments, and site inventory. Participate in initial IRT builds, UAT, and any changes within the system
- Monitor inventory levels at depots and clinical sites
- Manage label development and approval process
- Manage CMO for packaging, labeling, distribution, storage, distribution, and reconciliation of returns
- Manage inspection readiness activities, including filing in TMF, returns and reconciliation, storyboards, etc.
- Bachelor's degree in a science, supply chain, or related discipline
- 3+ years of relevant industry experience, knowledge of the complete clinical supplies life cycle preferred
- Working knowledge of the International Conference on Harmonization (ICH) guidelines, Good Clinical Practice (GCP), the Code of Federal Regulations (CFR), and EMA GMP and GDP Guidelines and a solid understanding of Good Manufacturing Practices (GMP), the Code of Federal Regulations (CFR),
- Understand the roles/responsibilities and inter-dependencies for key functions involved in clinical supply
- Excellent interpersonal skills and problem solving/decision making skills
Our Locations
Waltham, MA: Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO: We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter/parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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Cogent Biosciences is a biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to a...
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