Your Role:

  • You will lead and mentor a team providing operational support to the Pharmaceutical Development team (Drug Product, Drug Substance and Supply Chain) including: CMC logistics, budgets, accruals, vendor contracting.
  • You will propose and implement initiatives to grow effective CMC Operations culture and institute best practices within the CMC teams.
  • You will help negotiate, obtain, and review for accuracy legal and corporate approval for master service agreements, CDAs and related statements of work for pharmaceutical development activities with external partners.
  • You will work with business unit head, accounting, finance, and functional leaders to support creation and maintenance of pharmaceutical development budget and forecast.
  • You will be responsible for ensuring CMC resources, budget, forecast and timelines are in alignment with product development and registration strategies.
  • You will create, manage, and maintain adherence/adjustments to CMC timelines to enable IND / NDA filing of multiple compounds and track completion against milestones
  • You will pressure-test time-line assumptions and call attention to potential risks in consultation with relevant functional area.
  • You will work closely with Regulatory to perform a gap analysis(s) between the IND / NDA requirements and current regulatory or development plans.
  • You will coordinate GLP and GMP CMC Scale up & Development activities for IND enabling, clinical studies, and registration/validation batches.
  • You will collaborate with Project Manager(s) to develop, maintain, and deploy key project management tools and metrics and their consistent application across functions.
  • You will ensure timely and effective communication of project status, changes to plan, cost changes, and risks to project team members and department heads
  • You will participate in CMC and Supply Chain group meetings including follow up on Action Items and Timelines

Your Background:

  • You have earned a bachelor’s and/or master’s in pharmaceutical or a scientific discipline
  • You have 10+ years of experience in a drug development organization, with 6+ years in CMC operations (small molecules and oral solids experience preferred) or project management
  • You have knowledge of the overall drug development process from IND enabling studies to NDA filing
  • You routinely apply project /CMC operation principles and practices to integrate cross-functional execution strategies and communication
  • You have experience supporting CMC budgeting, forecasting, and accruals
  • You are comfortable working in a dynamic working environment and thrive in a fast-paced innovative environment with competing tasks
  • You have ability to manage multiple high-priority projects in parallel.
  • You bring a high degree of energy, motivation, and attention to detail
  • You work independently and successfully in a matrix environment
  • You have strong communication skills and problem-solving talents
  • You have knowledge of MS Project, SmartSheet, ThinkCell and MS Excel

#LI-JB1

About Relay Therapeutics

Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.  

Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us! 

Company policy requires that all employees be fully vaccinated against COVID-19, and all new hires must be fully vaccinated (as defined by the CDC) by the time they start employment. By applying to this position, you are confirming that, if hired, you can satisfy this express condition of employment. The Company will make reasonable accommodations under applicable law for qualified individuals to enable them to perform the essential functions of the job, unless doing so would create an undue hardship for the Company.

 

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