Full-Time

Senior Manager

Clinical Supply Chain

Confirmed live in the last 24 hours

Relay Therapeutics

Relay Therapeutics

201-500 employees

Precision medicines company targeting genetic diseases

AI & Machine Learning
Data & Analytics

Mid

Cambridge, MA, USA

Required Skills
Communications
Requirements
  • BS/BA or equivalent in operations, life sciences, or health-related field
  • Minimum of three to five years relevant (e.g., clinical, pharmaceutics, clinical trial material) pharmaceutical/biotechnology experience
  • Experience with investigational drug product primary/secondary packaging and labeling processes
  • Experience with distribution and recall processes for investigational products
  • Experience with CMO contracts and vendor management
  • Clinical study site interaction skills
  • Knowledge of cGMPs and relevant FDA and EU regulations
  • Detail orientated and process focused
  • Excellent communication (written and oral) and interpersonal skills
  • Adept and diplomatic in interacting with senior management both within the organization and with external organizations, consultants and vendors
  • Work effectively with team members across all levels of the organization
  • Able to prioritize multiple tasks from multiple parties and work in a fast-paced environment with tight deadlines
Responsibilities
  • Responsible for forecasting clinical supply needs for regional and global Phase I, II and III studies based on an in-depth understanding of clinical trial protocols and detailed discussions with Clinical Operations and Regulatory on demand assumptions
  • Reviews IP inventory levels at depots and sites and takes anticipatory actions to avoid interruptions to supply
  • Procures concomitant and comparator drugs for clinical trials as needed
  • Authors English label text, coordinates translations, and approves label design for investigational drugs used in clinical trials while maintaining proper regulatory and quality standards
  • Plans, schedules, and oversees packaging and labeling operations at clinical supply vendors
  • Reviews and approves clinical supply packaging and labeling batch records
  • Reviews Clinical Supply sections of all relevant clinical and regulatory documents
  • Monitors depots and sites for proper storage of all investigational product
  • Dispositions temperature excursions and improves processes to minimize the impact of excursions
  • Coordinates and tracks drug product shipments to and from all clinical sites
  • Facilitates import and export documents such as: Import License, special permits, Proforma Invoice, and additional documentation required to transport clinical trial material (CTM) to its final destination
  • Reviews/approves user requirements and specifications and performs User Acceptance Testing (UAT) on new and existing IXRS systems
  • Coordinates returns and destruction of investigational product at sites and depots
  • Develops and reviews CRO/vendor proposals and contracts for packaging/labeling/distribution of investigational product
  • Collaborates with Quality to author and review CTM SOPs and business practices as needed
  • Maintains documentation in an audit-ready state

Relay Therapeutics is dedicated to advancing the field of precision medicine by employing its innovative Dynamo TM Platform to visualize protein motion through high-definition movies. This cutting-edge approach enhances its ability to drug targets more effectively, especially in critical areas like precision oncology and genetic diseases. The company's commitment to leveraging advanced experimental and computational methodologies in structural biology, biophysics, chemistry, and biology positions it as a leader in developing targeted therapies that address complex diseases. Working at Relay Therapeutics offers a unique opportunity to contribute to transformative healthcare solutions and operate at the forefront of biotechnological research.

Company Stage

IPO

Total Funding

$1.2B

Headquarters

Cambridge, Massachusetts

Founded

2016

Growth & Insights
Headcount

6 month growth

-5%

1 year growth

-6%

2 year growth

7%

Benefits

Medical, dental, vision

Life, disability, & FSA

401k

Commuter benefits

Parental leave

Home office stipend

Tuition reimbursement

PTO