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Director / Sr Director, Clinical Business Operations

Cambridge, MA

The Opportunity:

As Director / Senior Director, Clinical Business Operations, you will play a pivotal role in enabling the success of Relay Tx’s clinical programs. You will partner with the cross-functional team members and leadership in Clinical Development, Finance, and Legal to assess the best fit for Relay Tx’s growing pipeline as you lead the development of outsourcing strategies as well as vendor selection and contracting, vendor budgeting and accruals. You will also be responsible for communicating with clinical study sites to negotiate and implement clinical site study budgets and payment terms. To be successful, you will be skilled at developing and leveraging relationships with external vendors for strong business results and know how to structure service agreements/contracts to drive accountability, quality and performance. You will be experienced in outsourcing management, contract and budget negotiation, budget management, and vendor financial oversight.

Your Role:

  • Lead the end-to-end RFI/RFP process in collaboration with key stakeholders as needed, i.e., Clinical Operations, Regulatory, Data Management, Biostatistics, Medical, Finance, Legal, IT, and other key stakeholders.
  • Lead negotiations and execute agreements, budgets, payment terms, and change orders to optimize vendor relationships, and maximize Relay Therapeutics’ cash position.
  • Drive cost savings and improve operational efficiency through innovative sourcing strategies and preferred financial models for CROs and other high-spend or key vendors, including discount structures.
  • You will work with the VP, Clinical Operational Excellence and the cross-functional team and leadership to refine function-specific governance processes, which include joint oversight committee membership, with key clinical vendors to monitor financial performance and manage issue escalation and resolution.
  • You will partner with the Legal team to develop the Clinical Trial Agreements (CTAs), lead the development of clinical site budgets, and partner with CRO counterparts to negotiate with sites.
  • You will partner with Finance on a variety of clinical finance deliverables as needed, e.g., clinical trial budgeting, forecasting, long-range plan (LRP), accruals (vendor and site), and reporting with variance analysis and comments.
  • You will support the Clinical Working Groups in the review and approval of vendor invoices to ensure their accuracy as well as the review of monthly and/or quarterly accrual estimates and review of out-of-scope expense items.
  • You will provide support for financial planning and the financial management of clinical studies/programs, including developing more efficient budget and budget tracking processes.
  • You will lead and mentor junior team members to support their development and enable program deliverables.
  • You will drive, challenge, and improve our existing systems and processes to improve performance.

 

 

Your Background:                                 

  • You have 10+ years of experience in clinical vendor outsourcing, management and/or clinical financial management. Both Sponsor & CRO experience is strongly preferred.
  • You have experience with all aspects of vendor oversight or alliance management: from vendor selection and contracting to vendor financial performance management and relationship building.
  • You have expertise working with cross-functional teams, within Clinical Development as well as Finance, Legal, and Quality with hands-on financial analytics experience.
  • You have extensive knowledge of the drug development process and regulatory requirements (ICH, GCP, 21 CFR Part 11).
  • You have broad knowledge of legal principles and procedures as they relate to vendor and clinical site contracts.
  • You possess excellent interpersonal skills to build strong and trusted relationships internally across functions, as well as with external vendors.
  • You have exceptional negotiation, analytical, project management, and decision-making skills.
  • You are a highly driven and self-motivated individual, with a commitment to the highest standards of ethics, honesty, and integrity.
  • You are pragmatic and adaptable to managing multiple projects, commitments and needs effectively.
  • You have outstanding verbal and written communication skills, allowing for an open and effective dialogue throughout the organization.
  • You are proficient in using contract lifecycle systems as well as creating dashboards and reports for management.
  • You possess the ability to influence without authority, lead change and manage resistance to change. You must be able to solicit information, persuade others and shape outcomes.
  • You have a strong work ethic, excellent problem-solving ability, and attention to detail and quality which are critical to success.

#ASM1

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! 

 

 

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